JOURNAL CLUB

1 November 2004

Case

• 54M• Ca Rectum LAR• Background

– Smoker +++– DM– Previous L hemisphere CVA– Cervical spondylosis

Case

• Pre-op anaesthetic r/v– Request for carotid dopplers – R ICA: 80% stenosis (asymptomatic)

Clinical questions

• Does this pt require intervention?

• What options exist?

• How do these compare?

Background

• NASCET 1991– CEA reduced stroke risk from 26% to

9% at 2 years for stenosis >70%BUT

– Exclusion criteria• Severe HT, DM• Recent CVA• >80yr

– Risk of death/stroke from procedure 5%

Background

• ACAS trial 1995– CEA reduced stroke risk from 11% to

5% at 5 years for stenosis >60%– Risk of stoke/death from procedure

3%

Clinical Answers

• Does this pt require intervention?Yes

• What options exist?Carotid endarterectomyCarotid stenting

• How do these compare?

Evidence-Based Medicine

• Protected Carotid-Artery Stenting versus Endarterectomy in High Risk Patients– Yadav JS, Wholey MH et al – New England Journal of Medicine– October 7, 2004 351(15): 1493-501– www.nejm.org

SAPPHIRE TRIAL

• Stenting and• Angioplasty with• Protection in• Patients at• High• Risk for • Endarterectomy

SAPPHIRE TRIAL

• Aim– To show that carotid stenting with

protection is NOT INFERIOR to endarterectomy

SAPPHIRE TRIAL

• Multicentre (29), RCT• Surgeons and ‘interventionalists’

screened• Selection for entry into trial by

multidisciplinary group

SAPPHIRE TRIAL

• Inclusion criteria– Symptomatic >50% stenosis– Asymptomatic >80% stenosis– >1 significant co-morbidity

• Cardiac or Pulmonary ds• Bilateral or recurrent stenoses• >80yr

SAPPHIRE TRIAL

• Exclusion criteria– CVA <48hr– Intra-luminal thrombus– Cerebral aneurysm– Blood dyscrasia (clopidogrel)

SAPPHIRE TRIAL

• CEA– As per routine practice

• Stent– Self-expanding with filter basket

(100m)

Angioguard XP©, Cordis J&J

SAPPHIRE TRIAL

• Follow-up– 30 days, 6 months, 12 monthly for 3

yr– Duplex doppler at each visit +/- angio

SAPPHIRE TRIAL

• Primary end-points– Within 30 days

• Death• Stroke• MI

– 31 days to 1 yr• Death• Ipsilateral stroke

SAPPHIRE TRIAL

• Secondary end-points– Need for revascularisation– CN palsy– Minor wound complications

SAPPHIRE TRIAL

• Results

4 0 6 s ten t(n o t ran d om ised )

1 5 9 ac tu a l s ten t

1 6 7 s ten t

1 5 1 op era ted

1 6 7 C E A

3 3 4 ran d om ised 7 C E A(n o t ran d om ised )

7 4 7 p ts en ro lled

SAPPHIRE TRIAL

• All patients (intention-to-treat analysis)

• Primary end point (Death/Stroke/MI)– 20/167 stent group (12.2%)– 32/167 CEA group (20.1%)– p=0.004 for non-inferiority

SAPPHIRE TRIAL

• Symptomatic patients (28.8%)• Primary end point

(Death/Stroke/MI)– 16.8% stent group– 16.5% CEA group

SAPPHIRE TRIAL

• Strengths– RCT– Aim for non-inferiority– Identical results for actually treated

pts

SAPPHIRE TRIAL

• Weaknesses– Allocation to randomise– Early cessation of study– ?Affiliation of investigators

Clinical Answers

• Does this pt require intervention?Yes

• What options exist?Carotid endarterectomyCarotid stenting

• How do these compare?Stenting with protection is not inferior