update in carotid artery stenting & stroke management dr. nikolaos melas, phd vascular and...

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UPDATE IN CAROTID ARTERY UPDATE IN CAROTID ARTERY STENTING & STROKE MANAGEMENT STENTING & STROKE MANAGEMENT Dr. Nikolaos Melas, PhD Vascular and Endovascular Surgeon Military Doctor Associate in 1st department of Surgery, Aristotle University of Thessaloniki, Greece Associate in Interbalcan Medical Center

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UPDATE IN CAROTID ARTERY UPDATE IN CAROTID ARTERY STENTING amp STROKE STENTING amp STROKE

MANAGEMENTMANAGEMENT

Dr Nikolaos Melas PhDVascular and Endovascular Surgeon

Military Doctor

Associate in 1st department of Surgery Aristotle University of Thessaloniki Greece

Associate in Interbalcan Medical Center

Atherothrombotic embolization from ICA plaque

Natural history of CADNatural history of CAD

Natural history of CADNatural history of CADCan produce TIA or Stroke

Natural history of CADNatural history of CADCausing transient or permanent disability

And even deathStroke is the third leading cause of death worldwide1

1Moore WS et al Circulation 1995 91566 ndash79

bullA valuable therapeutic option for stroke management over simple medical treatment since 1954 Eastcott first description

CEACEAASPIRINASPIRIN

Carotid endarterectomy (CEA)Carotid endarterectomy (CEA)

TrialTrialTrialTrial Mean Mean Follow-upFollow-upMean Mean Follow-upFollow-up

Rate of New Rate of New Neurologic EventsNeurologic Events

Rate of New Rate of New Neurologic EventsNeurologic Events

ACASACASACASACAS AsymptomaticN= 1662 27 years27 years27 years27 years 11111111 51515151

ACSTACSTACSTACST Asymptomatic 5 years5 years5 years5 years 1178117811781178 64646464

Significant 5 year absolute risk reduction of apr 5

Offered Up to 17 relative risk reduction of major cardiovascular events

CEA for symptomatic patientsCEA for symptomatic patients

CEA for asymptomatic patientsCEA for asymptomatic patients

Carotid endarterectomy (CEA)Carotid endarterectomy (CEA)

Carotid Artery Stenting (CAS)Carotid Artery Stenting (CAS)bullLess invasivebullLess traumaticbullLess time consuming bullPainlessbullAvoids neck incisionsbullAvoids nerve damagebullAvoids systemic complications related to anesthesia

Remained the gold standard for carotid Remained the gold standard for carotid artery disease for many years as an artery disease for many years as an

evidence based procedureevidence based procedure

RESULTS

Single center retrospective reports Initial experience with CAS

Prospective multicenter registries for CAS

CAS vs CEA Controlled trials

CAS vs CEA meta- analysis (Cochrane review)

Evidence for CAS

Controlled trials CAS vs CEA

meta- analysis (Cochrane review)

Ederle J et al Cochrane systematic review Stroke 200940(4)1373-80

Coward L et al Cochrane systematic review Stroke 2005 36905-11

Controlled trials comparing CAS with CEA

Ederle J et al Cochrane systematic review Stroke 2009 Apr40(4)1373-80

Slightly favored CEA

Death or stroke within 30 days of procedure

Criticism on EVA-3S and SPACE trials- weak points

bull inadequate sample size (type II statistical error)

bull different stent systems

bull different protocols in pre- and post- administration of antiplatelet drugs

bull not uniform use of EPDs

bull not similar patient groups (eg four times as many people with contralateral ICA occlusion in the CAS group in EVA-3S)

bull surprisingly better results of French surgeons (EVA-3S) in performing CEA comparing to NASCET and ECST (39 vs 65 and 71)

The results do not support a change in clinical practice away from recommending carotid endarterectomy as the treatment of choice for suitable carotid artery stenosis but support continued recruitment in the large ongoing trials

Trial Year FU CAS ips stroke CEA ips stroke P Article

SPACE 2008 2 years 95 885 NS Lancet Neurol 2008 7 893-902

EVA-3s 2008 4 years After the periprocedural period the risk of ipsilateral stroke was low and similar in both treatment groups

NS Lancet Neurol 2008 7 885-892

SAPPHIRE 2008 3 years 6 87 NS N Engl j Med 2008 358 1572-79

CAVATAS 2009 5 years 11middot3 8middot6 NS Lancet Neurol 20098(10)898-907

CREST 2011

Mid and Long term results (6m-5 years)

Coward LJ et al Cochrane review Stroke 200536905-911

Equal results between CEA and CAS

Cranial neuropathy

Stronly favored CAS

No significant difference in the major risks of treatment

Minor complication favorendovascular treatment

Conclusions

Insufficient evidence to support a widespread change in clinical practice

So which is the VERDICT

Current trials didnrsquot prove CAS inferiority

The initial question about gold standard is wrong

vsXBoth CAS CEAand

Play a role in stroke prevention in different patient groups

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

The influence of anatomy on treatment selection for carotid disease

1 Congenital anatomical variation (bovine arch aortic arch types I-III high or low carotid bifurcation aberrant vessels)

2 Alterations that occur with aging and hypertension (inflow and outflow tortuousity calcification thrombi)

3 Extension of disease (eg diffuse multisegmental disease involving the proximal CCA or distal ICA)

Vessel anatomy

Schneider PA et al Semin Vasc Surg 20216-225 2007

Vessel anatomy

Aortic arch type and orificial calcification

Vessel anatomy

Mobile thrombi Vessel anatomy

Vessel anatomyBovine carotid configuration

Proximal common carotid lesionsVessel anatomy

Tortuous CCA or ICA coil

Vessel anatomy

ldquoString signrdquo carotid morphology

Would you advance an EPD into such a vessel

Vessel anatomy

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

Plaque characteristics

Biasi et al ICAROS study Circulation 2004110756-62Fisher M et al Stroke 200536253ndash7Rothwell PM et al Stroke 200031615ndash21

bullGSMlt25 is related with a higher risk of neurologic complications after CASbulllow GSM is not a contraindication to CAS but rather a predictor of increased stroke riskbullLow GSM values are further related to future coronary events and higher rate of restenosis

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

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Atherothrombotic embolization from ICA plaque

Natural history of CADNatural history of CAD

Natural history of CADNatural history of CADCan produce TIA or Stroke

Natural history of CADNatural history of CADCausing transient or permanent disability

And even deathStroke is the third leading cause of death worldwide1

1Moore WS et al Circulation 1995 91566 ndash79

bullA valuable therapeutic option for stroke management over simple medical treatment since 1954 Eastcott first description

CEACEAASPIRINASPIRIN

Carotid endarterectomy (CEA)Carotid endarterectomy (CEA)

TrialTrialTrialTrial Mean Mean Follow-upFollow-upMean Mean Follow-upFollow-up

Rate of New Rate of New Neurologic EventsNeurologic Events

Rate of New Rate of New Neurologic EventsNeurologic Events

ACASACASACASACAS AsymptomaticN= 1662 27 years27 years27 years27 years 11111111 51515151

ACSTACSTACSTACST Asymptomatic 5 years5 years5 years5 years 1178117811781178 64646464

Significant 5 year absolute risk reduction of apr 5

Offered Up to 17 relative risk reduction of major cardiovascular events

CEA for symptomatic patientsCEA for symptomatic patients

CEA for asymptomatic patientsCEA for asymptomatic patients

Carotid endarterectomy (CEA)Carotid endarterectomy (CEA)

Carotid Artery Stenting (CAS)Carotid Artery Stenting (CAS)bullLess invasivebullLess traumaticbullLess time consuming bullPainlessbullAvoids neck incisionsbullAvoids nerve damagebullAvoids systemic complications related to anesthesia

Remained the gold standard for carotid Remained the gold standard for carotid artery disease for many years as an artery disease for many years as an

evidence based procedureevidence based procedure

RESULTS

Single center retrospective reports Initial experience with CAS

Prospective multicenter registries for CAS

CAS vs CEA Controlled trials

CAS vs CEA meta- analysis (Cochrane review)

Evidence for CAS

Controlled trials CAS vs CEA

meta- analysis (Cochrane review)

Ederle J et al Cochrane systematic review Stroke 200940(4)1373-80

Coward L et al Cochrane systematic review Stroke 2005 36905-11

Controlled trials comparing CAS with CEA

Ederle J et al Cochrane systematic review Stroke 2009 Apr40(4)1373-80

Slightly favored CEA

Death or stroke within 30 days of procedure

Criticism on EVA-3S and SPACE trials- weak points

bull inadequate sample size (type II statistical error)

bull different stent systems

bull different protocols in pre- and post- administration of antiplatelet drugs

bull not uniform use of EPDs

bull not similar patient groups (eg four times as many people with contralateral ICA occlusion in the CAS group in EVA-3S)

bull surprisingly better results of French surgeons (EVA-3S) in performing CEA comparing to NASCET and ECST (39 vs 65 and 71)

The results do not support a change in clinical practice away from recommending carotid endarterectomy as the treatment of choice for suitable carotid artery stenosis but support continued recruitment in the large ongoing trials

Trial Year FU CAS ips stroke CEA ips stroke P Article

SPACE 2008 2 years 95 885 NS Lancet Neurol 2008 7 893-902

EVA-3s 2008 4 years After the periprocedural period the risk of ipsilateral stroke was low and similar in both treatment groups

NS Lancet Neurol 2008 7 885-892

SAPPHIRE 2008 3 years 6 87 NS N Engl j Med 2008 358 1572-79

CAVATAS 2009 5 years 11middot3 8middot6 NS Lancet Neurol 20098(10)898-907

CREST 2011

Mid and Long term results (6m-5 years)

Coward LJ et al Cochrane review Stroke 200536905-911

Equal results between CEA and CAS

Cranial neuropathy

Stronly favored CAS

No significant difference in the major risks of treatment

Minor complication favorendovascular treatment

Conclusions

Insufficient evidence to support a widespread change in clinical practice

So which is the VERDICT

Current trials didnrsquot prove CAS inferiority

The initial question about gold standard is wrong

vsXBoth CAS CEAand

Play a role in stroke prevention in different patient groups

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

The influence of anatomy on treatment selection for carotid disease

1 Congenital anatomical variation (bovine arch aortic arch types I-III high or low carotid bifurcation aberrant vessels)

2 Alterations that occur with aging and hypertension (inflow and outflow tortuousity calcification thrombi)

3 Extension of disease (eg diffuse multisegmental disease involving the proximal CCA or distal ICA)

Vessel anatomy

Schneider PA et al Semin Vasc Surg 20216-225 2007

Vessel anatomy

Aortic arch type and orificial calcification

Vessel anatomy

Mobile thrombi Vessel anatomy

Vessel anatomyBovine carotid configuration

Proximal common carotid lesionsVessel anatomy

Tortuous CCA or ICA coil

Vessel anatomy

ldquoString signrdquo carotid morphology

Would you advance an EPD into such a vessel

Vessel anatomy

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

Plaque characteristics

Biasi et al ICAROS study Circulation 2004110756-62Fisher M et al Stroke 200536253ndash7Rothwell PM et al Stroke 200031615ndash21

bullGSMlt25 is related with a higher risk of neurologic complications after CASbulllow GSM is not a contraindication to CAS but rather a predictor of increased stroke riskbullLow GSM values are further related to future coronary events and higher rate of restenosis

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

  • Slide 1
  • Slide 2
  • Slide 3
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Natural history of CADNatural history of CADCan produce TIA or Stroke

Natural history of CADNatural history of CADCausing transient or permanent disability

And even deathStroke is the third leading cause of death worldwide1

1Moore WS et al Circulation 1995 91566 ndash79

bullA valuable therapeutic option for stroke management over simple medical treatment since 1954 Eastcott first description

CEACEAASPIRINASPIRIN

Carotid endarterectomy (CEA)Carotid endarterectomy (CEA)

TrialTrialTrialTrial Mean Mean Follow-upFollow-upMean Mean Follow-upFollow-up

Rate of New Rate of New Neurologic EventsNeurologic Events

Rate of New Rate of New Neurologic EventsNeurologic Events

ACASACASACASACAS AsymptomaticN= 1662 27 years27 years27 years27 years 11111111 51515151

ACSTACSTACSTACST Asymptomatic 5 years5 years5 years5 years 1178117811781178 64646464

Significant 5 year absolute risk reduction of apr 5

Offered Up to 17 relative risk reduction of major cardiovascular events

CEA for symptomatic patientsCEA for symptomatic patients

CEA for asymptomatic patientsCEA for asymptomatic patients

Carotid endarterectomy (CEA)Carotid endarterectomy (CEA)

Carotid Artery Stenting (CAS)Carotid Artery Stenting (CAS)bullLess invasivebullLess traumaticbullLess time consuming bullPainlessbullAvoids neck incisionsbullAvoids nerve damagebullAvoids systemic complications related to anesthesia

Remained the gold standard for carotid Remained the gold standard for carotid artery disease for many years as an artery disease for many years as an

evidence based procedureevidence based procedure

RESULTS

Single center retrospective reports Initial experience with CAS

Prospective multicenter registries for CAS

CAS vs CEA Controlled trials

CAS vs CEA meta- analysis (Cochrane review)

Evidence for CAS

Controlled trials CAS vs CEA

meta- analysis (Cochrane review)

Ederle J et al Cochrane systematic review Stroke 200940(4)1373-80

Coward L et al Cochrane systematic review Stroke 2005 36905-11

Controlled trials comparing CAS with CEA

Ederle J et al Cochrane systematic review Stroke 2009 Apr40(4)1373-80

Slightly favored CEA

Death or stroke within 30 days of procedure

Criticism on EVA-3S and SPACE trials- weak points

bull inadequate sample size (type II statistical error)

bull different stent systems

bull different protocols in pre- and post- administration of antiplatelet drugs

bull not uniform use of EPDs

bull not similar patient groups (eg four times as many people with contralateral ICA occlusion in the CAS group in EVA-3S)

bull surprisingly better results of French surgeons (EVA-3S) in performing CEA comparing to NASCET and ECST (39 vs 65 and 71)

The results do not support a change in clinical practice away from recommending carotid endarterectomy as the treatment of choice for suitable carotid artery stenosis but support continued recruitment in the large ongoing trials

Trial Year FU CAS ips stroke CEA ips stroke P Article

SPACE 2008 2 years 95 885 NS Lancet Neurol 2008 7 893-902

EVA-3s 2008 4 years After the periprocedural period the risk of ipsilateral stroke was low and similar in both treatment groups

NS Lancet Neurol 2008 7 885-892

SAPPHIRE 2008 3 years 6 87 NS N Engl j Med 2008 358 1572-79

CAVATAS 2009 5 years 11middot3 8middot6 NS Lancet Neurol 20098(10)898-907

CREST 2011

Mid and Long term results (6m-5 years)

Coward LJ et al Cochrane review Stroke 200536905-911

Equal results between CEA and CAS

Cranial neuropathy

Stronly favored CAS

No significant difference in the major risks of treatment

Minor complication favorendovascular treatment

Conclusions

Insufficient evidence to support a widespread change in clinical practice

So which is the VERDICT

Current trials didnrsquot prove CAS inferiority

The initial question about gold standard is wrong

vsXBoth CAS CEAand

Play a role in stroke prevention in different patient groups

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

The influence of anatomy on treatment selection for carotid disease

1 Congenital anatomical variation (bovine arch aortic arch types I-III high or low carotid bifurcation aberrant vessels)

2 Alterations that occur with aging and hypertension (inflow and outflow tortuousity calcification thrombi)

3 Extension of disease (eg diffuse multisegmental disease involving the proximal CCA or distal ICA)

Vessel anatomy

Schneider PA et al Semin Vasc Surg 20216-225 2007

Vessel anatomy

Aortic arch type and orificial calcification

Vessel anatomy

Mobile thrombi Vessel anatomy

Vessel anatomyBovine carotid configuration

Proximal common carotid lesionsVessel anatomy

Tortuous CCA or ICA coil

Vessel anatomy

ldquoString signrdquo carotid morphology

Would you advance an EPD into such a vessel

Vessel anatomy

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

Plaque characteristics

Biasi et al ICAROS study Circulation 2004110756-62Fisher M et al Stroke 200536253ndash7Rothwell PM et al Stroke 200031615ndash21

bullGSMlt25 is related with a higher risk of neurologic complications after CASbulllow GSM is not a contraindication to CAS but rather a predictor of increased stroke riskbullLow GSM values are further related to future coronary events and higher rate of restenosis

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

  • Slide 1
  • Slide 2
  • Slide 3
  • Slide 4
  • Slide 5
  • Slide 6
  • Slide 7
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  • Slide 40

Natural history of CADNatural history of CADCausing transient or permanent disability

And even deathStroke is the third leading cause of death worldwide1

1Moore WS et al Circulation 1995 91566 ndash79

bullA valuable therapeutic option for stroke management over simple medical treatment since 1954 Eastcott first description

CEACEAASPIRINASPIRIN

Carotid endarterectomy (CEA)Carotid endarterectomy (CEA)

TrialTrialTrialTrial Mean Mean Follow-upFollow-upMean Mean Follow-upFollow-up

Rate of New Rate of New Neurologic EventsNeurologic Events

Rate of New Rate of New Neurologic EventsNeurologic Events

ACASACASACASACAS AsymptomaticN= 1662 27 years27 years27 years27 years 11111111 51515151

ACSTACSTACSTACST Asymptomatic 5 years5 years5 years5 years 1178117811781178 64646464

Significant 5 year absolute risk reduction of apr 5

Offered Up to 17 relative risk reduction of major cardiovascular events

CEA for symptomatic patientsCEA for symptomatic patients

CEA for asymptomatic patientsCEA for asymptomatic patients

Carotid endarterectomy (CEA)Carotid endarterectomy (CEA)

Carotid Artery Stenting (CAS)Carotid Artery Stenting (CAS)bullLess invasivebullLess traumaticbullLess time consuming bullPainlessbullAvoids neck incisionsbullAvoids nerve damagebullAvoids systemic complications related to anesthesia

Remained the gold standard for carotid Remained the gold standard for carotid artery disease for many years as an artery disease for many years as an

evidence based procedureevidence based procedure

RESULTS

Single center retrospective reports Initial experience with CAS

Prospective multicenter registries for CAS

CAS vs CEA Controlled trials

CAS vs CEA meta- analysis (Cochrane review)

Evidence for CAS

Controlled trials CAS vs CEA

meta- analysis (Cochrane review)

Ederle J et al Cochrane systematic review Stroke 200940(4)1373-80

Coward L et al Cochrane systematic review Stroke 2005 36905-11

Controlled trials comparing CAS with CEA

Ederle J et al Cochrane systematic review Stroke 2009 Apr40(4)1373-80

Slightly favored CEA

Death or stroke within 30 days of procedure

Criticism on EVA-3S and SPACE trials- weak points

bull inadequate sample size (type II statistical error)

bull different stent systems

bull different protocols in pre- and post- administration of antiplatelet drugs

bull not uniform use of EPDs

bull not similar patient groups (eg four times as many people with contralateral ICA occlusion in the CAS group in EVA-3S)

bull surprisingly better results of French surgeons (EVA-3S) in performing CEA comparing to NASCET and ECST (39 vs 65 and 71)

The results do not support a change in clinical practice away from recommending carotid endarterectomy as the treatment of choice for suitable carotid artery stenosis but support continued recruitment in the large ongoing trials

Trial Year FU CAS ips stroke CEA ips stroke P Article

SPACE 2008 2 years 95 885 NS Lancet Neurol 2008 7 893-902

EVA-3s 2008 4 years After the periprocedural period the risk of ipsilateral stroke was low and similar in both treatment groups

NS Lancet Neurol 2008 7 885-892

SAPPHIRE 2008 3 years 6 87 NS N Engl j Med 2008 358 1572-79

CAVATAS 2009 5 years 11middot3 8middot6 NS Lancet Neurol 20098(10)898-907

CREST 2011

Mid and Long term results (6m-5 years)

Coward LJ et al Cochrane review Stroke 200536905-911

Equal results between CEA and CAS

Cranial neuropathy

Stronly favored CAS

No significant difference in the major risks of treatment

Minor complication favorendovascular treatment

Conclusions

Insufficient evidence to support a widespread change in clinical practice

So which is the VERDICT

Current trials didnrsquot prove CAS inferiority

The initial question about gold standard is wrong

vsXBoth CAS CEAand

Play a role in stroke prevention in different patient groups

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

The influence of anatomy on treatment selection for carotid disease

1 Congenital anatomical variation (bovine arch aortic arch types I-III high or low carotid bifurcation aberrant vessels)

2 Alterations that occur with aging and hypertension (inflow and outflow tortuousity calcification thrombi)

3 Extension of disease (eg diffuse multisegmental disease involving the proximal CCA or distal ICA)

Vessel anatomy

Schneider PA et al Semin Vasc Surg 20216-225 2007

Vessel anatomy

Aortic arch type and orificial calcification

Vessel anatomy

Mobile thrombi Vessel anatomy

Vessel anatomyBovine carotid configuration

Proximal common carotid lesionsVessel anatomy

Tortuous CCA or ICA coil

Vessel anatomy

ldquoString signrdquo carotid morphology

Would you advance an EPD into such a vessel

Vessel anatomy

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

Plaque characteristics

Biasi et al ICAROS study Circulation 2004110756-62Fisher M et al Stroke 200536253ndash7Rothwell PM et al Stroke 200031615ndash21

bullGSMlt25 is related with a higher risk of neurologic complications after CASbulllow GSM is not a contraindication to CAS but rather a predictor of increased stroke riskbullLow GSM values are further related to future coronary events and higher rate of restenosis

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

  • Slide 1
  • Slide 2
  • Slide 3
  • Slide 4
  • Slide 5
  • Slide 6
  • Slide 7
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bullA valuable therapeutic option for stroke management over simple medical treatment since 1954 Eastcott first description

CEACEAASPIRINASPIRIN

Carotid endarterectomy (CEA)Carotid endarterectomy (CEA)

TrialTrialTrialTrial Mean Mean Follow-upFollow-upMean Mean Follow-upFollow-up

Rate of New Rate of New Neurologic EventsNeurologic Events

Rate of New Rate of New Neurologic EventsNeurologic Events

ACASACASACASACAS AsymptomaticN= 1662 27 years27 years27 years27 years 11111111 51515151

ACSTACSTACSTACST Asymptomatic 5 years5 years5 years5 years 1178117811781178 64646464

Significant 5 year absolute risk reduction of apr 5

Offered Up to 17 relative risk reduction of major cardiovascular events

CEA for symptomatic patientsCEA for symptomatic patients

CEA for asymptomatic patientsCEA for asymptomatic patients

Carotid endarterectomy (CEA)Carotid endarterectomy (CEA)

Carotid Artery Stenting (CAS)Carotid Artery Stenting (CAS)bullLess invasivebullLess traumaticbullLess time consuming bullPainlessbullAvoids neck incisionsbullAvoids nerve damagebullAvoids systemic complications related to anesthesia

Remained the gold standard for carotid Remained the gold standard for carotid artery disease for many years as an artery disease for many years as an

evidence based procedureevidence based procedure

RESULTS

Single center retrospective reports Initial experience with CAS

Prospective multicenter registries for CAS

CAS vs CEA Controlled trials

CAS vs CEA meta- analysis (Cochrane review)

Evidence for CAS

Controlled trials CAS vs CEA

meta- analysis (Cochrane review)

Ederle J et al Cochrane systematic review Stroke 200940(4)1373-80

Coward L et al Cochrane systematic review Stroke 2005 36905-11

Controlled trials comparing CAS with CEA

Ederle J et al Cochrane systematic review Stroke 2009 Apr40(4)1373-80

Slightly favored CEA

Death or stroke within 30 days of procedure

Criticism on EVA-3S and SPACE trials- weak points

bull inadequate sample size (type II statistical error)

bull different stent systems

bull different protocols in pre- and post- administration of antiplatelet drugs

bull not uniform use of EPDs

bull not similar patient groups (eg four times as many people with contralateral ICA occlusion in the CAS group in EVA-3S)

bull surprisingly better results of French surgeons (EVA-3S) in performing CEA comparing to NASCET and ECST (39 vs 65 and 71)

The results do not support a change in clinical practice away from recommending carotid endarterectomy as the treatment of choice for suitable carotid artery stenosis but support continued recruitment in the large ongoing trials

Trial Year FU CAS ips stroke CEA ips stroke P Article

SPACE 2008 2 years 95 885 NS Lancet Neurol 2008 7 893-902

EVA-3s 2008 4 years After the periprocedural period the risk of ipsilateral stroke was low and similar in both treatment groups

NS Lancet Neurol 2008 7 885-892

SAPPHIRE 2008 3 years 6 87 NS N Engl j Med 2008 358 1572-79

CAVATAS 2009 5 years 11middot3 8middot6 NS Lancet Neurol 20098(10)898-907

CREST 2011

Mid and Long term results (6m-5 years)

Coward LJ et al Cochrane review Stroke 200536905-911

Equal results between CEA and CAS

Cranial neuropathy

Stronly favored CAS

No significant difference in the major risks of treatment

Minor complication favorendovascular treatment

Conclusions

Insufficient evidence to support a widespread change in clinical practice

So which is the VERDICT

Current trials didnrsquot prove CAS inferiority

The initial question about gold standard is wrong

vsXBoth CAS CEAand

Play a role in stroke prevention in different patient groups

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

The influence of anatomy on treatment selection for carotid disease

1 Congenital anatomical variation (bovine arch aortic arch types I-III high or low carotid bifurcation aberrant vessels)

2 Alterations that occur with aging and hypertension (inflow and outflow tortuousity calcification thrombi)

3 Extension of disease (eg diffuse multisegmental disease involving the proximal CCA or distal ICA)

Vessel anatomy

Schneider PA et al Semin Vasc Surg 20216-225 2007

Vessel anatomy

Aortic arch type and orificial calcification

Vessel anatomy

Mobile thrombi Vessel anatomy

Vessel anatomyBovine carotid configuration

Proximal common carotid lesionsVessel anatomy

Tortuous CCA or ICA coil

Vessel anatomy

ldquoString signrdquo carotid morphology

Would you advance an EPD into such a vessel

Vessel anatomy

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

Plaque characteristics

Biasi et al ICAROS study Circulation 2004110756-62Fisher M et al Stroke 200536253ndash7Rothwell PM et al Stroke 200031615ndash21

bullGSMlt25 is related with a higher risk of neurologic complications after CASbulllow GSM is not a contraindication to CAS but rather a predictor of increased stroke riskbullLow GSM values are further related to future coronary events and higher rate of restenosis

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

  • Slide 1
  • Slide 2
  • Slide 3
  • Slide 4
  • Slide 5
  • Slide 6
  • Slide 7
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TrialTrialTrialTrial Mean Mean Follow-upFollow-upMean Mean Follow-upFollow-up

Rate of New Rate of New Neurologic EventsNeurologic Events

Rate of New Rate of New Neurologic EventsNeurologic Events

ACASACASACASACAS AsymptomaticN= 1662 27 years27 years27 years27 years 11111111 51515151

ACSTACSTACSTACST Asymptomatic 5 years5 years5 years5 years 1178117811781178 64646464

Significant 5 year absolute risk reduction of apr 5

Offered Up to 17 relative risk reduction of major cardiovascular events

CEA for symptomatic patientsCEA for symptomatic patients

CEA for asymptomatic patientsCEA for asymptomatic patients

Carotid endarterectomy (CEA)Carotid endarterectomy (CEA)

Carotid Artery Stenting (CAS)Carotid Artery Stenting (CAS)bullLess invasivebullLess traumaticbullLess time consuming bullPainlessbullAvoids neck incisionsbullAvoids nerve damagebullAvoids systemic complications related to anesthesia

Remained the gold standard for carotid Remained the gold standard for carotid artery disease for many years as an artery disease for many years as an

evidence based procedureevidence based procedure

RESULTS

Single center retrospective reports Initial experience with CAS

Prospective multicenter registries for CAS

CAS vs CEA Controlled trials

CAS vs CEA meta- analysis (Cochrane review)

Evidence for CAS

Controlled trials CAS vs CEA

meta- analysis (Cochrane review)

Ederle J et al Cochrane systematic review Stroke 200940(4)1373-80

Coward L et al Cochrane systematic review Stroke 2005 36905-11

Controlled trials comparing CAS with CEA

Ederle J et al Cochrane systematic review Stroke 2009 Apr40(4)1373-80

Slightly favored CEA

Death or stroke within 30 days of procedure

Criticism on EVA-3S and SPACE trials- weak points

bull inadequate sample size (type II statistical error)

bull different stent systems

bull different protocols in pre- and post- administration of antiplatelet drugs

bull not uniform use of EPDs

bull not similar patient groups (eg four times as many people with contralateral ICA occlusion in the CAS group in EVA-3S)

bull surprisingly better results of French surgeons (EVA-3S) in performing CEA comparing to NASCET and ECST (39 vs 65 and 71)

The results do not support a change in clinical practice away from recommending carotid endarterectomy as the treatment of choice for suitable carotid artery stenosis but support continued recruitment in the large ongoing trials

Trial Year FU CAS ips stroke CEA ips stroke P Article

SPACE 2008 2 years 95 885 NS Lancet Neurol 2008 7 893-902

EVA-3s 2008 4 years After the periprocedural period the risk of ipsilateral stroke was low and similar in both treatment groups

NS Lancet Neurol 2008 7 885-892

SAPPHIRE 2008 3 years 6 87 NS N Engl j Med 2008 358 1572-79

CAVATAS 2009 5 years 11middot3 8middot6 NS Lancet Neurol 20098(10)898-907

CREST 2011

Mid and Long term results (6m-5 years)

Coward LJ et al Cochrane review Stroke 200536905-911

Equal results between CEA and CAS

Cranial neuropathy

Stronly favored CAS

No significant difference in the major risks of treatment

Minor complication favorendovascular treatment

Conclusions

Insufficient evidence to support a widespread change in clinical practice

So which is the VERDICT

Current trials didnrsquot prove CAS inferiority

The initial question about gold standard is wrong

vsXBoth CAS CEAand

Play a role in stroke prevention in different patient groups

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

The influence of anatomy on treatment selection for carotid disease

1 Congenital anatomical variation (bovine arch aortic arch types I-III high or low carotid bifurcation aberrant vessels)

2 Alterations that occur with aging and hypertension (inflow and outflow tortuousity calcification thrombi)

3 Extension of disease (eg diffuse multisegmental disease involving the proximal CCA or distal ICA)

Vessel anatomy

Schneider PA et al Semin Vasc Surg 20216-225 2007

Vessel anatomy

Aortic arch type and orificial calcification

Vessel anatomy

Mobile thrombi Vessel anatomy

Vessel anatomyBovine carotid configuration

Proximal common carotid lesionsVessel anatomy

Tortuous CCA or ICA coil

Vessel anatomy

ldquoString signrdquo carotid morphology

Would you advance an EPD into such a vessel

Vessel anatomy

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

Plaque characteristics

Biasi et al ICAROS study Circulation 2004110756-62Fisher M et al Stroke 200536253ndash7Rothwell PM et al Stroke 200031615ndash21

bullGSMlt25 is related with a higher risk of neurologic complications after CASbulllow GSM is not a contraindication to CAS but rather a predictor of increased stroke riskbullLow GSM values are further related to future coronary events and higher rate of restenosis

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

  • Slide 1
  • Slide 2
  • Slide 3
  • Slide 4
  • Slide 5
  • Slide 6
  • Slide 7
  • Slide 8
  • Slide 9
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  • Slide 39
  • Slide 40

Carotid endarterectomy (CEA)Carotid endarterectomy (CEA)

Carotid Artery Stenting (CAS)Carotid Artery Stenting (CAS)bullLess invasivebullLess traumaticbullLess time consuming bullPainlessbullAvoids neck incisionsbullAvoids nerve damagebullAvoids systemic complications related to anesthesia

Remained the gold standard for carotid Remained the gold standard for carotid artery disease for many years as an artery disease for many years as an

evidence based procedureevidence based procedure

RESULTS

Single center retrospective reports Initial experience with CAS

Prospective multicenter registries for CAS

CAS vs CEA Controlled trials

CAS vs CEA meta- analysis (Cochrane review)

Evidence for CAS

Controlled trials CAS vs CEA

meta- analysis (Cochrane review)

Ederle J et al Cochrane systematic review Stroke 200940(4)1373-80

Coward L et al Cochrane systematic review Stroke 2005 36905-11

Controlled trials comparing CAS with CEA

Ederle J et al Cochrane systematic review Stroke 2009 Apr40(4)1373-80

Slightly favored CEA

Death or stroke within 30 days of procedure

Criticism on EVA-3S and SPACE trials- weak points

bull inadequate sample size (type II statistical error)

bull different stent systems

bull different protocols in pre- and post- administration of antiplatelet drugs

bull not uniform use of EPDs

bull not similar patient groups (eg four times as many people with contralateral ICA occlusion in the CAS group in EVA-3S)

bull surprisingly better results of French surgeons (EVA-3S) in performing CEA comparing to NASCET and ECST (39 vs 65 and 71)

The results do not support a change in clinical practice away from recommending carotid endarterectomy as the treatment of choice for suitable carotid artery stenosis but support continued recruitment in the large ongoing trials

Trial Year FU CAS ips stroke CEA ips stroke P Article

SPACE 2008 2 years 95 885 NS Lancet Neurol 2008 7 893-902

EVA-3s 2008 4 years After the periprocedural period the risk of ipsilateral stroke was low and similar in both treatment groups

NS Lancet Neurol 2008 7 885-892

SAPPHIRE 2008 3 years 6 87 NS N Engl j Med 2008 358 1572-79

CAVATAS 2009 5 years 11middot3 8middot6 NS Lancet Neurol 20098(10)898-907

CREST 2011

Mid and Long term results (6m-5 years)

Coward LJ et al Cochrane review Stroke 200536905-911

Equal results between CEA and CAS

Cranial neuropathy

Stronly favored CAS

No significant difference in the major risks of treatment

Minor complication favorendovascular treatment

Conclusions

Insufficient evidence to support a widespread change in clinical practice

So which is the VERDICT

Current trials didnrsquot prove CAS inferiority

The initial question about gold standard is wrong

vsXBoth CAS CEAand

Play a role in stroke prevention in different patient groups

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

The influence of anatomy on treatment selection for carotid disease

1 Congenital anatomical variation (bovine arch aortic arch types I-III high or low carotid bifurcation aberrant vessels)

2 Alterations that occur with aging and hypertension (inflow and outflow tortuousity calcification thrombi)

3 Extension of disease (eg diffuse multisegmental disease involving the proximal CCA or distal ICA)

Vessel anatomy

Schneider PA et al Semin Vasc Surg 20216-225 2007

Vessel anatomy

Aortic arch type and orificial calcification

Vessel anatomy

Mobile thrombi Vessel anatomy

Vessel anatomyBovine carotid configuration

Proximal common carotid lesionsVessel anatomy

Tortuous CCA or ICA coil

Vessel anatomy

ldquoString signrdquo carotid morphology

Would you advance an EPD into such a vessel

Vessel anatomy

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

Plaque characteristics

Biasi et al ICAROS study Circulation 2004110756-62Fisher M et al Stroke 200536253ndash7Rothwell PM et al Stroke 200031615ndash21

bullGSMlt25 is related with a higher risk of neurologic complications after CASbulllow GSM is not a contraindication to CAS but rather a predictor of increased stroke riskbullLow GSM values are further related to future coronary events and higher rate of restenosis

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

  • Slide 1
  • Slide 2
  • Slide 3
  • Slide 4
  • Slide 5
  • Slide 6
  • Slide 7
  • Slide 8
  • Slide 9
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  • Slide 35
  • Slide 36
  • Slide 37
  • Slide 38
  • Slide 39
  • Slide 40

Single center retrospective reports Initial experience with CAS

Prospective multicenter registries for CAS

CAS vs CEA Controlled trials

CAS vs CEA meta- analysis (Cochrane review)

Evidence for CAS

Controlled trials CAS vs CEA

meta- analysis (Cochrane review)

Ederle J et al Cochrane systematic review Stroke 200940(4)1373-80

Coward L et al Cochrane systematic review Stroke 2005 36905-11

Controlled trials comparing CAS with CEA

Ederle J et al Cochrane systematic review Stroke 2009 Apr40(4)1373-80

Slightly favored CEA

Death or stroke within 30 days of procedure

Criticism on EVA-3S and SPACE trials- weak points

bull inadequate sample size (type II statistical error)

bull different stent systems

bull different protocols in pre- and post- administration of antiplatelet drugs

bull not uniform use of EPDs

bull not similar patient groups (eg four times as many people with contralateral ICA occlusion in the CAS group in EVA-3S)

bull surprisingly better results of French surgeons (EVA-3S) in performing CEA comparing to NASCET and ECST (39 vs 65 and 71)

The results do not support a change in clinical practice away from recommending carotid endarterectomy as the treatment of choice for suitable carotid artery stenosis but support continued recruitment in the large ongoing trials

Trial Year FU CAS ips stroke CEA ips stroke P Article

SPACE 2008 2 years 95 885 NS Lancet Neurol 2008 7 893-902

EVA-3s 2008 4 years After the periprocedural period the risk of ipsilateral stroke was low and similar in both treatment groups

NS Lancet Neurol 2008 7 885-892

SAPPHIRE 2008 3 years 6 87 NS N Engl j Med 2008 358 1572-79

CAVATAS 2009 5 years 11middot3 8middot6 NS Lancet Neurol 20098(10)898-907

CREST 2011

Mid and Long term results (6m-5 years)

Coward LJ et al Cochrane review Stroke 200536905-911

Equal results between CEA and CAS

Cranial neuropathy

Stronly favored CAS

No significant difference in the major risks of treatment

Minor complication favorendovascular treatment

Conclusions

Insufficient evidence to support a widespread change in clinical practice

So which is the VERDICT

Current trials didnrsquot prove CAS inferiority

The initial question about gold standard is wrong

vsXBoth CAS CEAand

Play a role in stroke prevention in different patient groups

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

The influence of anatomy on treatment selection for carotid disease

1 Congenital anatomical variation (bovine arch aortic arch types I-III high or low carotid bifurcation aberrant vessels)

2 Alterations that occur with aging and hypertension (inflow and outflow tortuousity calcification thrombi)

3 Extension of disease (eg diffuse multisegmental disease involving the proximal CCA or distal ICA)

Vessel anatomy

Schneider PA et al Semin Vasc Surg 20216-225 2007

Vessel anatomy

Aortic arch type and orificial calcification

Vessel anatomy

Mobile thrombi Vessel anatomy

Vessel anatomyBovine carotid configuration

Proximal common carotid lesionsVessel anatomy

Tortuous CCA or ICA coil

Vessel anatomy

ldquoString signrdquo carotid morphology

Would you advance an EPD into such a vessel

Vessel anatomy

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

Plaque characteristics

Biasi et al ICAROS study Circulation 2004110756-62Fisher M et al Stroke 200536253ndash7Rothwell PM et al Stroke 200031615ndash21

bullGSMlt25 is related with a higher risk of neurologic complications after CASbulllow GSM is not a contraindication to CAS but rather a predictor of increased stroke riskbullLow GSM values are further related to future coronary events and higher rate of restenosis

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

  • Slide 1
  • Slide 2
  • Slide 3
  • Slide 4
  • Slide 5
  • Slide 6
  • Slide 7
  • Slide 8
  • Slide 9
  • Slide 10
  • Slide 11
  • Slide 12
  • Slide 13
  • Slide 14
  • Slide 15
  • Slide 16
  • Slide 17
  • Slide 18
  • Slide 19
  • Slide 20
  • Slide 21
  • Slide 22
  • Slide 23
  • Slide 24
  • Slide 25
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  • Slide 27
  • Slide 28
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  • Slide 32
  • Slide 33
  • Slide 34
  • Slide 35
  • Slide 36
  • Slide 37
  • Slide 38
  • Slide 39
  • Slide 40

Controlled trials CAS vs CEA

meta- analysis (Cochrane review)

Ederle J et al Cochrane systematic review Stroke 200940(4)1373-80

Coward L et al Cochrane systematic review Stroke 2005 36905-11

Controlled trials comparing CAS with CEA

Ederle J et al Cochrane systematic review Stroke 2009 Apr40(4)1373-80

Slightly favored CEA

Death or stroke within 30 days of procedure

Criticism on EVA-3S and SPACE trials- weak points

bull inadequate sample size (type II statistical error)

bull different stent systems

bull different protocols in pre- and post- administration of antiplatelet drugs

bull not uniform use of EPDs

bull not similar patient groups (eg four times as many people with contralateral ICA occlusion in the CAS group in EVA-3S)

bull surprisingly better results of French surgeons (EVA-3S) in performing CEA comparing to NASCET and ECST (39 vs 65 and 71)

The results do not support a change in clinical practice away from recommending carotid endarterectomy as the treatment of choice for suitable carotid artery stenosis but support continued recruitment in the large ongoing trials

Trial Year FU CAS ips stroke CEA ips stroke P Article

SPACE 2008 2 years 95 885 NS Lancet Neurol 2008 7 893-902

EVA-3s 2008 4 years After the periprocedural period the risk of ipsilateral stroke was low and similar in both treatment groups

NS Lancet Neurol 2008 7 885-892

SAPPHIRE 2008 3 years 6 87 NS N Engl j Med 2008 358 1572-79

CAVATAS 2009 5 years 11middot3 8middot6 NS Lancet Neurol 20098(10)898-907

CREST 2011

Mid and Long term results (6m-5 years)

Coward LJ et al Cochrane review Stroke 200536905-911

Equal results between CEA and CAS

Cranial neuropathy

Stronly favored CAS

No significant difference in the major risks of treatment

Minor complication favorendovascular treatment

Conclusions

Insufficient evidence to support a widespread change in clinical practice

So which is the VERDICT

Current trials didnrsquot prove CAS inferiority

The initial question about gold standard is wrong

vsXBoth CAS CEAand

Play a role in stroke prevention in different patient groups

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

The influence of anatomy on treatment selection for carotid disease

1 Congenital anatomical variation (bovine arch aortic arch types I-III high or low carotid bifurcation aberrant vessels)

2 Alterations that occur with aging and hypertension (inflow and outflow tortuousity calcification thrombi)

3 Extension of disease (eg diffuse multisegmental disease involving the proximal CCA or distal ICA)

Vessel anatomy

Schneider PA et al Semin Vasc Surg 20216-225 2007

Vessel anatomy

Aortic arch type and orificial calcification

Vessel anatomy

Mobile thrombi Vessel anatomy

Vessel anatomyBovine carotid configuration

Proximal common carotid lesionsVessel anatomy

Tortuous CCA or ICA coil

Vessel anatomy

ldquoString signrdquo carotid morphology

Would you advance an EPD into such a vessel

Vessel anatomy

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

Plaque characteristics

Biasi et al ICAROS study Circulation 2004110756-62Fisher M et al Stroke 200536253ndash7Rothwell PM et al Stroke 200031615ndash21

bullGSMlt25 is related with a higher risk of neurologic complications after CASbulllow GSM is not a contraindication to CAS but rather a predictor of increased stroke riskbullLow GSM values are further related to future coronary events and higher rate of restenosis

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

  • Slide 1
  • Slide 2
  • Slide 3
  • Slide 4
  • Slide 5
  • Slide 6
  • Slide 7
  • Slide 8
  • Slide 9
  • Slide 10
  • Slide 11
  • Slide 12
  • Slide 13
  • Slide 14
  • Slide 15
  • Slide 16
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  • Slide 31
  • Slide 32
  • Slide 33
  • Slide 34
  • Slide 35
  • Slide 36
  • Slide 37
  • Slide 38
  • Slide 39
  • Slide 40

Controlled trials comparing CAS with CEA

Ederle J et al Cochrane systematic review Stroke 2009 Apr40(4)1373-80

Slightly favored CEA

Death or stroke within 30 days of procedure

Criticism on EVA-3S and SPACE trials- weak points

bull inadequate sample size (type II statistical error)

bull different stent systems

bull different protocols in pre- and post- administration of antiplatelet drugs

bull not uniform use of EPDs

bull not similar patient groups (eg four times as many people with contralateral ICA occlusion in the CAS group in EVA-3S)

bull surprisingly better results of French surgeons (EVA-3S) in performing CEA comparing to NASCET and ECST (39 vs 65 and 71)

The results do not support a change in clinical practice away from recommending carotid endarterectomy as the treatment of choice for suitable carotid artery stenosis but support continued recruitment in the large ongoing trials

Trial Year FU CAS ips stroke CEA ips stroke P Article

SPACE 2008 2 years 95 885 NS Lancet Neurol 2008 7 893-902

EVA-3s 2008 4 years After the periprocedural period the risk of ipsilateral stroke was low and similar in both treatment groups

NS Lancet Neurol 2008 7 885-892

SAPPHIRE 2008 3 years 6 87 NS N Engl j Med 2008 358 1572-79

CAVATAS 2009 5 years 11middot3 8middot6 NS Lancet Neurol 20098(10)898-907

CREST 2011

Mid and Long term results (6m-5 years)

Coward LJ et al Cochrane review Stroke 200536905-911

Equal results between CEA and CAS

Cranial neuropathy

Stronly favored CAS

No significant difference in the major risks of treatment

Minor complication favorendovascular treatment

Conclusions

Insufficient evidence to support a widespread change in clinical practice

So which is the VERDICT

Current trials didnrsquot prove CAS inferiority

The initial question about gold standard is wrong

vsXBoth CAS CEAand

Play a role in stroke prevention in different patient groups

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

The influence of anatomy on treatment selection for carotid disease

1 Congenital anatomical variation (bovine arch aortic arch types I-III high or low carotid bifurcation aberrant vessels)

2 Alterations that occur with aging and hypertension (inflow and outflow tortuousity calcification thrombi)

3 Extension of disease (eg diffuse multisegmental disease involving the proximal CCA or distal ICA)

Vessel anatomy

Schneider PA et al Semin Vasc Surg 20216-225 2007

Vessel anatomy

Aortic arch type and orificial calcification

Vessel anatomy

Mobile thrombi Vessel anatomy

Vessel anatomyBovine carotid configuration

Proximal common carotid lesionsVessel anatomy

Tortuous CCA or ICA coil

Vessel anatomy

ldquoString signrdquo carotid morphology

Would you advance an EPD into such a vessel

Vessel anatomy

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

Plaque characteristics

Biasi et al ICAROS study Circulation 2004110756-62Fisher M et al Stroke 200536253ndash7Rothwell PM et al Stroke 200031615ndash21

bullGSMlt25 is related with a higher risk of neurologic complications after CASbulllow GSM is not a contraindication to CAS but rather a predictor of increased stroke riskbullLow GSM values are further related to future coronary events and higher rate of restenosis

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

  • Slide 1
  • Slide 2
  • Slide 3
  • Slide 4
  • Slide 5
  • Slide 6
  • Slide 7
  • Slide 8
  • Slide 9
  • Slide 10
  • Slide 11
  • Slide 12
  • Slide 13
  • Slide 14
  • Slide 15
  • Slide 16
  • Slide 17
  • Slide 18
  • Slide 19
  • Slide 20
  • Slide 21
  • Slide 22
  • Slide 23
  • Slide 24
  • Slide 25
  • Slide 26
  • Slide 27
  • Slide 28
  • Slide 29
  • Slide 30
  • Slide 31
  • Slide 32
  • Slide 33
  • Slide 34
  • Slide 35
  • Slide 36
  • Slide 37
  • Slide 38
  • Slide 39
  • Slide 40

Criticism on EVA-3S and SPACE trials- weak points

bull inadequate sample size (type II statistical error)

bull different stent systems

bull different protocols in pre- and post- administration of antiplatelet drugs

bull not uniform use of EPDs

bull not similar patient groups (eg four times as many people with contralateral ICA occlusion in the CAS group in EVA-3S)

bull surprisingly better results of French surgeons (EVA-3S) in performing CEA comparing to NASCET and ECST (39 vs 65 and 71)

The results do not support a change in clinical practice away from recommending carotid endarterectomy as the treatment of choice for suitable carotid artery stenosis but support continued recruitment in the large ongoing trials

Trial Year FU CAS ips stroke CEA ips stroke P Article

SPACE 2008 2 years 95 885 NS Lancet Neurol 2008 7 893-902

EVA-3s 2008 4 years After the periprocedural period the risk of ipsilateral stroke was low and similar in both treatment groups

NS Lancet Neurol 2008 7 885-892

SAPPHIRE 2008 3 years 6 87 NS N Engl j Med 2008 358 1572-79

CAVATAS 2009 5 years 11middot3 8middot6 NS Lancet Neurol 20098(10)898-907

CREST 2011

Mid and Long term results (6m-5 years)

Coward LJ et al Cochrane review Stroke 200536905-911

Equal results between CEA and CAS

Cranial neuropathy

Stronly favored CAS

No significant difference in the major risks of treatment

Minor complication favorendovascular treatment

Conclusions

Insufficient evidence to support a widespread change in clinical practice

So which is the VERDICT

Current trials didnrsquot prove CAS inferiority

The initial question about gold standard is wrong

vsXBoth CAS CEAand

Play a role in stroke prevention in different patient groups

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

The influence of anatomy on treatment selection for carotid disease

1 Congenital anatomical variation (bovine arch aortic arch types I-III high or low carotid bifurcation aberrant vessels)

2 Alterations that occur with aging and hypertension (inflow and outflow tortuousity calcification thrombi)

3 Extension of disease (eg diffuse multisegmental disease involving the proximal CCA or distal ICA)

Vessel anatomy

Schneider PA et al Semin Vasc Surg 20216-225 2007

Vessel anatomy

Aortic arch type and orificial calcification

Vessel anatomy

Mobile thrombi Vessel anatomy

Vessel anatomyBovine carotid configuration

Proximal common carotid lesionsVessel anatomy

Tortuous CCA or ICA coil

Vessel anatomy

ldquoString signrdquo carotid morphology

Would you advance an EPD into such a vessel

Vessel anatomy

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

Plaque characteristics

Biasi et al ICAROS study Circulation 2004110756-62Fisher M et al Stroke 200536253ndash7Rothwell PM et al Stroke 200031615ndash21

bullGSMlt25 is related with a higher risk of neurologic complications after CASbulllow GSM is not a contraindication to CAS but rather a predictor of increased stroke riskbullLow GSM values are further related to future coronary events and higher rate of restenosis

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

  • Slide 1
  • Slide 2
  • Slide 3
  • Slide 4
  • Slide 5
  • Slide 6
  • Slide 7
  • Slide 8
  • Slide 9
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Trial Year FU CAS ips stroke CEA ips stroke P Article

SPACE 2008 2 years 95 885 NS Lancet Neurol 2008 7 893-902

EVA-3s 2008 4 years After the periprocedural period the risk of ipsilateral stroke was low and similar in both treatment groups

NS Lancet Neurol 2008 7 885-892

SAPPHIRE 2008 3 years 6 87 NS N Engl j Med 2008 358 1572-79

CAVATAS 2009 5 years 11middot3 8middot6 NS Lancet Neurol 20098(10)898-907

CREST 2011

Mid and Long term results (6m-5 years)

Coward LJ et al Cochrane review Stroke 200536905-911

Equal results between CEA and CAS

Cranial neuropathy

Stronly favored CAS

No significant difference in the major risks of treatment

Minor complication favorendovascular treatment

Conclusions

Insufficient evidence to support a widespread change in clinical practice

So which is the VERDICT

Current trials didnrsquot prove CAS inferiority

The initial question about gold standard is wrong

vsXBoth CAS CEAand

Play a role in stroke prevention in different patient groups

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

The influence of anatomy on treatment selection for carotid disease

1 Congenital anatomical variation (bovine arch aortic arch types I-III high or low carotid bifurcation aberrant vessels)

2 Alterations that occur with aging and hypertension (inflow and outflow tortuousity calcification thrombi)

3 Extension of disease (eg diffuse multisegmental disease involving the proximal CCA or distal ICA)

Vessel anatomy

Schneider PA et al Semin Vasc Surg 20216-225 2007

Vessel anatomy

Aortic arch type and orificial calcification

Vessel anatomy

Mobile thrombi Vessel anatomy

Vessel anatomyBovine carotid configuration

Proximal common carotid lesionsVessel anatomy

Tortuous CCA or ICA coil

Vessel anatomy

ldquoString signrdquo carotid morphology

Would you advance an EPD into such a vessel

Vessel anatomy

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

Plaque characteristics

Biasi et al ICAROS study Circulation 2004110756-62Fisher M et al Stroke 200536253ndash7Rothwell PM et al Stroke 200031615ndash21

bullGSMlt25 is related with a higher risk of neurologic complications after CASbulllow GSM is not a contraindication to CAS but rather a predictor of increased stroke riskbullLow GSM values are further related to future coronary events and higher rate of restenosis

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

  • Slide 1
  • Slide 2
  • Slide 3
  • Slide 4
  • Slide 5
  • Slide 6
  • Slide 7
  • Slide 8
  • Slide 9
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  • Slide 33
  • Slide 34
  • Slide 35
  • Slide 36
  • Slide 37
  • Slide 38
  • Slide 39
  • Slide 40

Cranial neuropathy

Stronly favored CAS

No significant difference in the major risks of treatment

Minor complication favorendovascular treatment

Conclusions

Insufficient evidence to support a widespread change in clinical practice

So which is the VERDICT

Current trials didnrsquot prove CAS inferiority

The initial question about gold standard is wrong

vsXBoth CAS CEAand

Play a role in stroke prevention in different patient groups

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

The influence of anatomy on treatment selection for carotid disease

1 Congenital anatomical variation (bovine arch aortic arch types I-III high or low carotid bifurcation aberrant vessels)

2 Alterations that occur with aging and hypertension (inflow and outflow tortuousity calcification thrombi)

3 Extension of disease (eg diffuse multisegmental disease involving the proximal CCA or distal ICA)

Vessel anatomy

Schneider PA et al Semin Vasc Surg 20216-225 2007

Vessel anatomy

Aortic arch type and orificial calcification

Vessel anatomy

Mobile thrombi Vessel anatomy

Vessel anatomyBovine carotid configuration

Proximal common carotid lesionsVessel anatomy

Tortuous CCA or ICA coil

Vessel anatomy

ldquoString signrdquo carotid morphology

Would you advance an EPD into such a vessel

Vessel anatomy

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

Plaque characteristics

Biasi et al ICAROS study Circulation 2004110756-62Fisher M et al Stroke 200536253ndash7Rothwell PM et al Stroke 200031615ndash21

bullGSMlt25 is related with a higher risk of neurologic complications after CASbulllow GSM is not a contraindication to CAS but rather a predictor of increased stroke riskbullLow GSM values are further related to future coronary events and higher rate of restenosis

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

  • Slide 1
  • Slide 2
  • Slide 3
  • Slide 4
  • Slide 5
  • Slide 6
  • Slide 7
  • Slide 8
  • Slide 9
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  • Slide 34
  • Slide 35
  • Slide 36
  • Slide 37
  • Slide 38
  • Slide 39
  • Slide 40

No significant difference in the major risks of treatment

Minor complication favorendovascular treatment

Conclusions

Insufficient evidence to support a widespread change in clinical practice

So which is the VERDICT

Current trials didnrsquot prove CAS inferiority

The initial question about gold standard is wrong

vsXBoth CAS CEAand

Play a role in stroke prevention in different patient groups

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

The influence of anatomy on treatment selection for carotid disease

1 Congenital anatomical variation (bovine arch aortic arch types I-III high or low carotid bifurcation aberrant vessels)

2 Alterations that occur with aging and hypertension (inflow and outflow tortuousity calcification thrombi)

3 Extension of disease (eg diffuse multisegmental disease involving the proximal CCA or distal ICA)

Vessel anatomy

Schneider PA et al Semin Vasc Surg 20216-225 2007

Vessel anatomy

Aortic arch type and orificial calcification

Vessel anatomy

Mobile thrombi Vessel anatomy

Vessel anatomyBovine carotid configuration

Proximal common carotid lesionsVessel anatomy

Tortuous CCA or ICA coil

Vessel anatomy

ldquoString signrdquo carotid morphology

Would you advance an EPD into such a vessel

Vessel anatomy

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

Plaque characteristics

Biasi et al ICAROS study Circulation 2004110756-62Fisher M et al Stroke 200536253ndash7Rothwell PM et al Stroke 200031615ndash21

bullGSMlt25 is related with a higher risk of neurologic complications after CASbulllow GSM is not a contraindication to CAS but rather a predictor of increased stroke riskbullLow GSM values are further related to future coronary events and higher rate of restenosis

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

  • Slide 1
  • Slide 2
  • Slide 3
  • Slide 4
  • Slide 5
  • Slide 6
  • Slide 7
  • Slide 8
  • Slide 9
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  • Slide 33
  • Slide 34
  • Slide 35
  • Slide 36
  • Slide 37
  • Slide 38
  • Slide 39
  • Slide 40

So which is the VERDICT

Current trials didnrsquot prove CAS inferiority

The initial question about gold standard is wrong

vsXBoth CAS CEAand

Play a role in stroke prevention in different patient groups

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

The influence of anatomy on treatment selection for carotid disease

1 Congenital anatomical variation (bovine arch aortic arch types I-III high or low carotid bifurcation aberrant vessels)

2 Alterations that occur with aging and hypertension (inflow and outflow tortuousity calcification thrombi)

3 Extension of disease (eg diffuse multisegmental disease involving the proximal CCA or distal ICA)

Vessel anatomy

Schneider PA et al Semin Vasc Surg 20216-225 2007

Vessel anatomy

Aortic arch type and orificial calcification

Vessel anatomy

Mobile thrombi Vessel anatomy

Vessel anatomyBovine carotid configuration

Proximal common carotid lesionsVessel anatomy

Tortuous CCA or ICA coil

Vessel anatomy

ldquoString signrdquo carotid morphology

Would you advance an EPD into such a vessel

Vessel anatomy

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

Plaque characteristics

Biasi et al ICAROS study Circulation 2004110756-62Fisher M et al Stroke 200536253ndash7Rothwell PM et al Stroke 200031615ndash21

bullGSMlt25 is related with a higher risk of neurologic complications after CASbulllow GSM is not a contraindication to CAS but rather a predictor of increased stroke riskbullLow GSM values are further related to future coronary events and higher rate of restenosis

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

  • Slide 1
  • Slide 2
  • Slide 3
  • Slide 4
  • Slide 5
  • Slide 6
  • Slide 7
  • Slide 8
  • Slide 9
  • Slide 10
  • Slide 11
  • Slide 12
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  • Slide 32
  • Slide 33
  • Slide 34
  • Slide 35
  • Slide 36
  • Slide 37
  • Slide 38
  • Slide 39
  • Slide 40

The initial question about gold standard is wrong

vsXBoth CAS CEAand

Play a role in stroke prevention in different patient groups

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

The influence of anatomy on treatment selection for carotid disease

1 Congenital anatomical variation (bovine arch aortic arch types I-III high or low carotid bifurcation aberrant vessels)

2 Alterations that occur with aging and hypertension (inflow and outflow tortuousity calcification thrombi)

3 Extension of disease (eg diffuse multisegmental disease involving the proximal CCA or distal ICA)

Vessel anatomy

Schneider PA et al Semin Vasc Surg 20216-225 2007

Vessel anatomy

Aortic arch type and orificial calcification

Vessel anatomy

Mobile thrombi Vessel anatomy

Vessel anatomyBovine carotid configuration

Proximal common carotid lesionsVessel anatomy

Tortuous CCA or ICA coil

Vessel anatomy

ldquoString signrdquo carotid morphology

Would you advance an EPD into such a vessel

Vessel anatomy

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

Plaque characteristics

Biasi et al ICAROS study Circulation 2004110756-62Fisher M et al Stroke 200536253ndash7Rothwell PM et al Stroke 200031615ndash21

bullGSMlt25 is related with a higher risk of neurologic complications after CASbulllow GSM is not a contraindication to CAS but rather a predictor of increased stroke riskbullLow GSM values are further related to future coronary events and higher rate of restenosis

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

  • Slide 1
  • Slide 2
  • Slide 3
  • Slide 4
  • Slide 5
  • Slide 6
  • Slide 7
  • Slide 8
  • Slide 9
  • Slide 10
  • Slide 11
  • Slide 12
  • Slide 13
  • Slide 14
  • Slide 15
  • Slide 16
  • Slide 17
  • Slide 18
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  • Slide 20
  • Slide 21
  • Slide 22
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  • Slide 32
  • Slide 33
  • Slide 34
  • Slide 35
  • Slide 36
  • Slide 37
  • Slide 38
  • Slide 39
  • Slide 40

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

The influence of anatomy on treatment selection for carotid disease

1 Congenital anatomical variation (bovine arch aortic arch types I-III high or low carotid bifurcation aberrant vessels)

2 Alterations that occur with aging and hypertension (inflow and outflow tortuousity calcification thrombi)

3 Extension of disease (eg diffuse multisegmental disease involving the proximal CCA or distal ICA)

Vessel anatomy

Schneider PA et al Semin Vasc Surg 20216-225 2007

Vessel anatomy

Aortic arch type and orificial calcification

Vessel anatomy

Mobile thrombi Vessel anatomy

Vessel anatomyBovine carotid configuration

Proximal common carotid lesionsVessel anatomy

Tortuous CCA or ICA coil

Vessel anatomy

ldquoString signrdquo carotid morphology

Would you advance an EPD into such a vessel

Vessel anatomy

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

Plaque characteristics

Biasi et al ICAROS study Circulation 2004110756-62Fisher M et al Stroke 200536253ndash7Rothwell PM et al Stroke 200031615ndash21

bullGSMlt25 is related with a higher risk of neurologic complications after CASbulllow GSM is not a contraindication to CAS but rather a predictor of increased stroke riskbullLow GSM values are further related to future coronary events and higher rate of restenosis

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

  • Slide 1
  • Slide 2
  • Slide 3
  • Slide 4
  • Slide 5
  • Slide 6
  • Slide 7
  • Slide 8
  • Slide 9
  • Slide 10
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  • Slide 32
  • Slide 33
  • Slide 34
  • Slide 35
  • Slide 36
  • Slide 37
  • Slide 38
  • Slide 39
  • Slide 40

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

The influence of anatomy on treatment selection for carotid disease

1 Congenital anatomical variation (bovine arch aortic arch types I-III high or low carotid bifurcation aberrant vessels)

2 Alterations that occur with aging and hypertension (inflow and outflow tortuousity calcification thrombi)

3 Extension of disease (eg diffuse multisegmental disease involving the proximal CCA or distal ICA)

Vessel anatomy

Schneider PA et al Semin Vasc Surg 20216-225 2007

Vessel anatomy

Aortic arch type and orificial calcification

Vessel anatomy

Mobile thrombi Vessel anatomy

Vessel anatomyBovine carotid configuration

Proximal common carotid lesionsVessel anatomy

Tortuous CCA or ICA coil

Vessel anatomy

ldquoString signrdquo carotid morphology

Would you advance an EPD into such a vessel

Vessel anatomy

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

Plaque characteristics

Biasi et al ICAROS study Circulation 2004110756-62Fisher M et al Stroke 200536253ndash7Rothwell PM et al Stroke 200031615ndash21

bullGSMlt25 is related with a higher risk of neurologic complications after CASbulllow GSM is not a contraindication to CAS but rather a predictor of increased stroke riskbullLow GSM values are further related to future coronary events and higher rate of restenosis

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

  • Slide 1
  • Slide 2
  • Slide 3
  • Slide 4
  • Slide 5
  • Slide 6
  • Slide 7
  • Slide 8
  • Slide 9
  • Slide 10
  • Slide 11
  • Slide 12
  • Slide 13
  • Slide 14
  • Slide 15
  • Slide 16
  • Slide 17
  • Slide 18
  • Slide 19
  • Slide 20
  • Slide 21
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  • Slide 23
  • Slide 24
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  • Slide 27
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  • Slide 31
  • Slide 32
  • Slide 33
  • Slide 34
  • Slide 35
  • Slide 36
  • Slide 37
  • Slide 38
  • Slide 39
  • Slide 40

The influence of anatomy on treatment selection for carotid disease

1 Congenital anatomical variation (bovine arch aortic arch types I-III high or low carotid bifurcation aberrant vessels)

2 Alterations that occur with aging and hypertension (inflow and outflow tortuousity calcification thrombi)

3 Extension of disease (eg diffuse multisegmental disease involving the proximal CCA or distal ICA)

Vessel anatomy

Schneider PA et al Semin Vasc Surg 20216-225 2007

Vessel anatomy

Aortic arch type and orificial calcification

Vessel anatomy

Mobile thrombi Vessel anatomy

Vessel anatomyBovine carotid configuration

Proximal common carotid lesionsVessel anatomy

Tortuous CCA or ICA coil

Vessel anatomy

ldquoString signrdquo carotid morphology

Would you advance an EPD into such a vessel

Vessel anatomy

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

Plaque characteristics

Biasi et al ICAROS study Circulation 2004110756-62Fisher M et al Stroke 200536253ndash7Rothwell PM et al Stroke 200031615ndash21

bullGSMlt25 is related with a higher risk of neurologic complications after CASbulllow GSM is not a contraindication to CAS but rather a predictor of increased stroke riskbullLow GSM values are further related to future coronary events and higher rate of restenosis

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

  • Slide 1
  • Slide 2
  • Slide 3
  • Slide 4
  • Slide 5
  • Slide 6
  • Slide 7
  • Slide 8
  • Slide 9
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  • Slide 35
  • Slide 36
  • Slide 37
  • Slide 38
  • Slide 39
  • Slide 40

Schneider PA et al Semin Vasc Surg 20216-225 2007

Vessel anatomy

Aortic arch type and orificial calcification

Vessel anatomy

Mobile thrombi Vessel anatomy

Vessel anatomyBovine carotid configuration

Proximal common carotid lesionsVessel anatomy

Tortuous CCA or ICA coil

Vessel anatomy

ldquoString signrdquo carotid morphology

Would you advance an EPD into such a vessel

Vessel anatomy

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

Plaque characteristics

Biasi et al ICAROS study Circulation 2004110756-62Fisher M et al Stroke 200536253ndash7Rothwell PM et al Stroke 200031615ndash21

bullGSMlt25 is related with a higher risk of neurologic complications after CASbulllow GSM is not a contraindication to CAS but rather a predictor of increased stroke riskbullLow GSM values are further related to future coronary events and higher rate of restenosis

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

  • Slide 1
  • Slide 2
  • Slide 3
  • Slide 4
  • Slide 5
  • Slide 6
  • Slide 7
  • Slide 8
  • Slide 9
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  • Slide 34
  • Slide 35
  • Slide 36
  • Slide 37
  • Slide 38
  • Slide 39
  • Slide 40

Aortic arch type and orificial calcification

Vessel anatomy

Mobile thrombi Vessel anatomy

Vessel anatomyBovine carotid configuration

Proximal common carotid lesionsVessel anatomy

Tortuous CCA or ICA coil

Vessel anatomy

ldquoString signrdquo carotid morphology

Would you advance an EPD into such a vessel

Vessel anatomy

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

Plaque characteristics

Biasi et al ICAROS study Circulation 2004110756-62Fisher M et al Stroke 200536253ndash7Rothwell PM et al Stroke 200031615ndash21

bullGSMlt25 is related with a higher risk of neurologic complications after CASbulllow GSM is not a contraindication to CAS but rather a predictor of increased stroke riskbullLow GSM values are further related to future coronary events and higher rate of restenosis

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

  • Slide 1
  • Slide 2
  • Slide 3
  • Slide 4
  • Slide 5
  • Slide 6
  • Slide 7
  • Slide 8
  • Slide 9
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  • Slide 32
  • Slide 33
  • Slide 34
  • Slide 35
  • Slide 36
  • Slide 37
  • Slide 38
  • Slide 39
  • Slide 40

Mobile thrombi Vessel anatomy

Vessel anatomyBovine carotid configuration

Proximal common carotid lesionsVessel anatomy

Tortuous CCA or ICA coil

Vessel anatomy

ldquoString signrdquo carotid morphology

Would you advance an EPD into such a vessel

Vessel anatomy

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

Plaque characteristics

Biasi et al ICAROS study Circulation 2004110756-62Fisher M et al Stroke 200536253ndash7Rothwell PM et al Stroke 200031615ndash21

bullGSMlt25 is related with a higher risk of neurologic complications after CASbulllow GSM is not a contraindication to CAS but rather a predictor of increased stroke riskbullLow GSM values are further related to future coronary events and higher rate of restenosis

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

  • Slide 1
  • Slide 2
  • Slide 3
  • Slide 4
  • Slide 5
  • Slide 6
  • Slide 7
  • Slide 8
  • Slide 9
  • Slide 10
  • Slide 11
  • Slide 12
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  • Slide 14
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  • Slide 31
  • Slide 32
  • Slide 33
  • Slide 34
  • Slide 35
  • Slide 36
  • Slide 37
  • Slide 38
  • Slide 39
  • Slide 40

Vessel anatomyBovine carotid configuration

Proximal common carotid lesionsVessel anatomy

Tortuous CCA or ICA coil

Vessel anatomy

ldquoString signrdquo carotid morphology

Would you advance an EPD into such a vessel

Vessel anatomy

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

Plaque characteristics

Biasi et al ICAROS study Circulation 2004110756-62Fisher M et al Stroke 200536253ndash7Rothwell PM et al Stroke 200031615ndash21

bullGSMlt25 is related with a higher risk of neurologic complications after CASbulllow GSM is not a contraindication to CAS but rather a predictor of increased stroke riskbullLow GSM values are further related to future coronary events and higher rate of restenosis

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

  • Slide 1
  • Slide 2
  • Slide 3
  • Slide 4
  • Slide 5
  • Slide 6
  • Slide 7
  • Slide 8
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  • Slide 36
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  • Slide 39
  • Slide 40

Proximal common carotid lesionsVessel anatomy

Tortuous CCA or ICA coil

Vessel anatomy

ldquoString signrdquo carotid morphology

Would you advance an EPD into such a vessel

Vessel anatomy

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

Plaque characteristics

Biasi et al ICAROS study Circulation 2004110756-62Fisher M et al Stroke 200536253ndash7Rothwell PM et al Stroke 200031615ndash21

bullGSMlt25 is related with a higher risk of neurologic complications after CASbulllow GSM is not a contraindication to CAS but rather a predictor of increased stroke riskbullLow GSM values are further related to future coronary events and higher rate of restenosis

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

  • Slide 1
  • Slide 2
  • Slide 3
  • Slide 4
  • Slide 5
  • Slide 6
  • Slide 7
  • Slide 8
  • Slide 9
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  • Slide 35
  • Slide 36
  • Slide 37
  • Slide 38
  • Slide 39
  • Slide 40

Tortuous CCA or ICA coil

Vessel anatomy

ldquoString signrdquo carotid morphology

Would you advance an EPD into such a vessel

Vessel anatomy

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

Plaque characteristics

Biasi et al ICAROS study Circulation 2004110756-62Fisher M et al Stroke 200536253ndash7Rothwell PM et al Stroke 200031615ndash21

bullGSMlt25 is related with a higher risk of neurologic complications after CASbulllow GSM is not a contraindication to CAS but rather a predictor of increased stroke riskbullLow GSM values are further related to future coronary events and higher rate of restenosis

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

  • Slide 1
  • Slide 2
  • Slide 3
  • Slide 4
  • Slide 5
  • Slide 6
  • Slide 7
  • Slide 8
  • Slide 9
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  • Slide 34
  • Slide 35
  • Slide 36
  • Slide 37
  • Slide 38
  • Slide 39
  • Slide 40

ldquoString signrdquo carotid morphology

Would you advance an EPD into such a vessel

Vessel anatomy

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

Plaque characteristics

Biasi et al ICAROS study Circulation 2004110756-62Fisher M et al Stroke 200536253ndash7Rothwell PM et al Stroke 200031615ndash21

bullGSMlt25 is related with a higher risk of neurologic complications after CASbulllow GSM is not a contraindication to CAS but rather a predictor of increased stroke riskbullLow GSM values are further related to future coronary events and higher rate of restenosis

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

  • Slide 1
  • Slide 2
  • Slide 3
  • Slide 4
  • Slide 5
  • Slide 6
  • Slide 7
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  • Slide 40

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomyPlaque characteristics

The high risk patient

Plaque characteristics

Biasi et al ICAROS study Circulation 2004110756-62Fisher M et al Stroke 200536253ndash7Rothwell PM et al Stroke 200031615ndash21

bullGSMlt25 is related with a higher risk of neurologic complications after CASbulllow GSM is not a contraindication to CAS but rather a predictor of increased stroke riskbullLow GSM values are further related to future coronary events and higher rate of restenosis

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

  • Slide 1
  • Slide 2
  • Slide 3
  • Slide 4
  • Slide 5
  • Slide 6
  • Slide 7
  • Slide 8
  • Slide 9
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  • Slide 40

Plaque characteristics

Biasi et al ICAROS study Circulation 2004110756-62Fisher M et al Stroke 200536253ndash7Rothwell PM et al Stroke 200031615ndash21

bullGSMlt25 is related with a higher risk of neurologic complications after CASbulllow GSM is not a contraindication to CAS but rather a predictor of increased stroke riskbullLow GSM values are further related to future coronary events and higher rate of restenosis

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

  • Slide 1
  • Slide 2
  • Slide 3
  • Slide 4
  • Slide 5
  • Slide 6
  • Slide 7
  • Slide 8
  • Slide 9
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  • Slide 33
  • Slide 34
  • Slide 35
  • Slide 36
  • Slide 37
  • Slide 38
  • Slide 39
  • Slide 40

Defining patient groups that either CEA or CAS is beneficial

Vessel anatomy Plaque characteristics

The high risk patient

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

  • Slide 1
  • Slide 2
  • Slide 3
  • Slide 4
  • Slide 5
  • Slide 6
  • Slide 7
  • Slide 8
  • Slide 9
  • Slide 10
  • Slide 11
  • Slide 12
  • Slide 13
  • Slide 14
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  • Slide 33
  • Slide 34
  • Slide 35
  • Slide 36
  • Slide 37
  • Slide 38
  • Slide 39
  • Slide 40

24 30

60

96

12

3624

48

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)

Stent (n=167)

30 Days endpoint

P=068 P=100P=017

P=014

Theldquohigh riskrdquo patient

126

7260

192

72

120

24

60

0

5

10

15

20

25

Death Stroke MI MAE

CEA (n=167)Stent (n=167)

SAPPHIRE CAS vs CEA

1 year results

P=014

P=083P=017

P=010

CEA can be performed in high-risk patients with acceptable standard complication rates

Mozes G et al Semin Vasc Surg 20051861ndash 8

octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

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octogenarians

121121

30-day stroke and death rate30-day stroke and death rate

5353 1313

Agegt80yAgegt80y Age 70-79yAge 70-79y Age 60-69Age 60-69

Is CAS safe in this subgroup

The CREST trial lead-in phase

Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

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Material - Methodsbull 67 monthsbull 520 patientsbull mean age 76 range 56-85bull 364 male (70) 156 female (30)bull mean follow-up was 32 months (range 1 ndash 54 months)

Retrospective study

bull We conducted a retrospective review of CAS from 2003 to 2008bull RX Acculink - RX Accunet carotid system (Guidant Abott)

Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

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Material - Methods

bull Symptomatic (stroke (135) TIA Fugax) 515

bull Asymptomatic 485

Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

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Results within early follow-up (lt30 days)

bull Mortality (09)Stroke (11)TIA (13)Non fatal MI (13)

MAE 46

Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

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Results within early follow-up (lt30 days)

Predictors of adverse outcomes includedbullAge gt80bullsymptomatic patientsbullFemale genderbullpredilation prior to CPD bullplacement of multiple stentsbullContralateral occlusionbullUnfavorable anatomy

Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

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Late Follow-Up (gt30 days)

bull Mortality (173 )Stroke (07)Restenosis gt70 (23)

Mean follow-up was 32 months (range 1 ndash 60 months) 46 (88) patients lost of FU

Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

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Conclusion

bullCAS within experienced hands can be highly efficient and durable

Acculink Accunet system is safe and effective for CAS

ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

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ConclusionsCEA is the goal standard when

bull specific carotid anatomy

bullExtensive arch and carotid bif calcification

bullAccess related problems

bullFresh thrombus at ICA lesion

bullldquoString signrdquo morphology

bullVery low GSM

Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

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Conclusions

CAS and CEA are not competitive procedures but powerful treatment options tailored on different groups of patients

The gold standard is the experienced vascular team able to twist between endovascular and open surgical options in order to achieve the best treatment for the patient

Thank you for your attention

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Thank you for your attention

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