Carotid Stenting:St. Mary’s Hospital 2002

A clinical case

Carotid stent team

• Jeremy Chattaway

• Nick Cheshire

• Rodney Foale/Jamil Mayet/Iqbal Malik

• Martin Clark

Petrous

A2

A1

Ant Com Art

Cavernous

M2 upper

M2 lower

M1

Level of dura

Background

• Then:– “PTCA is barbaric and without evidence as a

treatment for CAD”

• Now:– Coronary stenting accepted as standard therapy

for CAD

• Could the same happen for carotid stenting?

Pre-requisites for success

• Prove surgery is better than tablets

• Prove percutaneous approach is almost as good as surgery

• Add stents/adjunctive therapy to make percutaneous equivalent to surgery

Case RH-1

• Age 63 male

• PMH Severe ARLAD

stenosisPoor LV

• Risk FactorsHT LipidsDM PVDEx- Smoking

• Cerebrovascular Hx

“TIA” 15 yrs ago

Asymptomatic now

• Cardiac Hx

increasing dyspnoea

no angina

Case RH-2

• Investigations

ECG Lat ST sag

Echo LV7/8cm

Mod severe AR

Creatinine 152 K 3.8

Hb 15.0

INR 1.2

• CVD Investigations

Duplex

MRA

Arch angio

Case RH-3

• Medication– Warfarin Digoxin 125mic– Bisoprolol 2.5 Amlodipine 5– Enalapril 15 bd Pravastatin 40– Imdur 30 Clopidogrel 75– Frusemide 40

Case RH- non-selective cerebral

Case RH-non-selective cerebral

Plan of action-RH

• Aim– Reduce CVA risk prior to AVR and grafts

• Rationale– Discussed twice at neurovascular meeting

• Risks of CEA high-not a suitable candidate

– Discussed twice at Joint cardiology/surgery meeting

• Needs AVR otherwise cardiac lifespan limited

– Discussed by CAS team

Evidence based medicine

• Risk of AVR/CABG

– >3000 ptsCVA risk

– Stenosis <50% 1.6%– Stenosis 50-99%

3.8%– Occlusion 6.5%– Occ+stenosis 25%

• CEA plus CABG/AVR

– CEA first• Cardiac risk very high

– Cardiac/CEA togather• Shorter stay 10 days• Higher CVA/death risk?• 9.5% vs 5.7% 30d risk

– Cardiac first• Asymptomatic >70%

stenosis 1%/yr CVA

Final Plan- RH

• Do Both Carotids with stents?

• Do one carotid only?– Risk of hyperperfusion

injury– Improve hemodynamic

reserve– Try second one later

Technique

0.035 guidewire

5F VTK catheter

Sheath introducer

7F shuttle sheath

R

RH RICA day 3

LICA to do

Hall LICA Procedue

Hall LICA

Hall LICA

Hall LICA

TRAP removal

RH

• Rx with aspirin + clopidogrel for 4 weeks

• Returned for AVR 4 weeks later– LIMA graft to LAD– Bileaflet AVR– Remarkable recovery

• Plan for home day 7

– Returned to ITU day 7• chest infection

– Home day 12

Pre-requisites for success

• Prove surgery is better than tablets

• Prove percutaneous approach is almost as good as surgery

• Add stents/adjunctive therapy to make percutaneous equivalent to surgery

Background

• Stroke in the population– 12% of all deaths in UK are due to CVA– 1 million CVA in Europe/year

• Carotid stenosis is major cause of CVA– Recent symptoms-28% 2-year risk CVA– Incidence of carotid stenosis >80% 0.3-2.4% of

population

Why have a stent program?

• CEA tricky

– Restenosis– Not C2-C7– Hostile neck

• RT• Surgery• Scars

– High risk• Medical Morbidity• Neuro Morbidity• RLN palsy contralat

• CAS

– Minimally Invasive– No scar– No GA Easy– Equivalent– Treatment of occlusion

post CEA

• Eastcott/ Debakey 1953 CEA

• NASCET (659)– >70% stenosis– 2-yr fu CVA 9% vs 26% on medical Rx

• ECST (3024)– >60% stenosis– 3-yr fu CVA 14.9% vs 26.5% on medical Rx

• ACAS– >60% stenosis– 5-yr fu CVA 5.1% vs 11% on medical Rx

Prove surgery is better than tablets

Prove percutaneous approach is almost as good as surgery

• Carotid and vertebral artery angioplasty study– Randomisation 1992-1997– 560 pts– 504 PTA vs surgery

– 86% stenosis

• Only 55 stents used– One CVA at time of stent.

CAVATAS

PTA Surgery p

30d death/CVA

10% 9.9% p=ns

CN palsy 0% 9% p<0.0001

Haematoma 1% 7% P=0.0015

MI 0% 0.8% ns

Re-stenosis 17% 5% P<0.0001

CAVATAS

• QOL same• Cost in lab same• Total cost greater for surgery as ITU stay

– £946

• Stent – cost of PTA from £1086 to £1864

Carotid Stenting

• At first…– 5 out of 7 had CVA with stent (RCT 1998)– 219 patients- death<1 year/CVA

12.1% stent vs. 3.6% CEA (p = 0.022). (RCT

2001)

• Randomised Trials

Stent vs surgery

• ICSS

• SPACE- Stent-protected Percutanous Angioplasty-Carotid Endarterectomy trial

• EVA-3S- Endarterectomy versus angioplasty in patients with severe symptomatic carotid stenosis study

• CREST- Carotid Revascularisation Endarterectomy vs stenting trial

• SAPPHIRE-Stenting and Angioplasty with protection in Patients with High Risk for Endarterectomy

Trial UpdateRandomized Studies

• CAVATAS completed(only 30% stent use)

• CREST (NIH/NHLBI)(U.S., 2500 pts., low risk)

• SAPPHIRE(U.S., 600-900 pts., high risk population

• CAVATAS 2 (society initiated)(worldwide 2000 pts.)

• SPACE (society initiated)(Germany, 1900 pts.)

High Risk Registriesincluding 2400 patients

• ARCHeR• Maverick• Beach• Mednova• Cabernet

World wide CAS

K. Mathias, H. Jaeger, ISET, Miami 2001

Asymptomatic

Data Treatment 30d CVA/death

ACAS Medical

CEA

0.4%

3%

Mathias CAS c DPD 1.6%

Wholey No DPD

DPD

3.97%

1.75%

Metanala CEA 3.4%

SAPPHIRE

2002

CAS c DPD

CEA

6.7%

11.2%

Data Treatment 30d CVA/death

NASCET Medical

CEA

3%

6.5%

ECST Medical

CEA

3%

7%

Wholey No DPD

DPD

6.7%

2.82%

CAVATAS CEA

CAS

9.9% (6.4)

9.9% (4.0)

SAPPHIRE

2002

CAS c DPD

CEA

4.2%

15.4%

Symptomatic

SMH 2002-a clinical case

• Patients with high risk

• A research program-ICSS

• Patient choice

Flanders study

Stenosis

Not suitable for CEA7.5%

Not suitable for CAS12.75%

CEA/CAS

Patient choice

CAS71%

CEA29%

ICSS entry criteria

Inclusion• >40• >70% stenosis• Extracranial IC or

bifurcation lesion

Excusion• CVA with no recovery• Can’t stent

– Tortuous– Thrombus– Common carotid stenosis– Pseudo-occlusion

• Can’t op

ICSS outcome events

• Death/ any CVA• TIA• MI<30d• CN palsy<30d• Hematoma (tx/op/long

stay)

• >70% stenosis at FU• Reintervention

• QOL• Costs

Conclusion

• The carotid is 25 years behind the coronary• It is catching up fast.

• Different vessel and vascular bed (cf diabetes)

• The multidisciplinary team

• SMH at the lead

Distal protection devicesDevice Pore size Delivery Retrieval PrepnRubicon

wire100Max

2F (0.028) nil nil

Angioguard XP (OTW)

100Max 8mm

3.2-3.9F

(2 wires)

OTW

5.1F

On table

CordisEpi-filter EX

Or EZ (Mono)80-110

3.5-5.5mm

EX 3.9F

EZ 3.0F

Mono

Sheath

On table

BostonSpider

(OTW)120-1303-7mm

2.9F Mono sheath

On table

EV3Interceptor

wire100

<6.5mm

2.9F Medtronic

TRAP

(OTW)100

<7mm

3.5F 4.5F Loading

EV3

Distal Protection devicesDevice Pore

sizeDelivery Retrieval Prepn

Arteria

(Parodi)- 10F nil Reverse

flow

Prox occ.MOMA

(OTW)- 11F 4.2-4.9F Not flow

reversal

Prox occ.Mednova

Percusurge (OTW/mono)

- - Distal occ.

Angioguard (Cordis)

Percusurge

ARTERIA (PARODI)