journal club 1 november 2004
TRANSCRIPT
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JOURNAL CLUB
1 November 2004
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Case
• 54M• Ca Rectum LAR• Background
– Smoker +++– DM– Previous L hemisphere CVA– Cervical spondylosis
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Case
• Pre-op anaesthetic r/v– Request for carotid dopplers – R ICA: 80% stenosis (asymptomatic)
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Clinical questions
• Does this pt require intervention?
• What options exist?
• How do these compare?
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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%
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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%
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Clinical Answers
• Does this pt require intervention?Yes
• What options exist?Carotid endarterectomyCarotid stenting
• How do these compare?
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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
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SAPPHIRE TRIAL
• Stenting and• Angioplasty with• Protection in• Patients at• High• Risk for • Endarterectomy
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SAPPHIRE TRIAL
• Aim– To show that carotid stenting with
protection is NOT INFERIOR to endarterectomy
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SAPPHIRE TRIAL
• Multicentre (29), RCT• Surgeons and ‘interventionalists’
screened• Selection for entry into trial by
multidisciplinary group
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SAPPHIRE TRIAL
• Inclusion criteria– Symptomatic >50% stenosis– Asymptomatic >80% stenosis– >1 significant co-morbidity
• Cardiac or Pulmonary ds• Bilateral or recurrent stenoses• >80yr
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SAPPHIRE TRIAL
• Exclusion criteria– CVA <48hr– Intra-luminal thrombus– Cerebral aneurysm– Blood dyscrasia (clopidogrel)
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SAPPHIRE TRIAL
• CEA– As per routine practice
• Stent– Self-expanding with filter basket
(100m)
Angioguard XP©, Cordis J&J
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SAPPHIRE TRIAL
• Follow-up– 30 days, 6 months, 12 monthly for 3
yr– Duplex doppler at each visit +/- angio
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SAPPHIRE TRIAL
• Primary end-points– Within 30 days
• Death• Stroke• MI
– 31 days to 1 yr• Death• Ipsilateral stroke
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SAPPHIRE TRIAL
• Secondary end-points– Need for revascularisation– CN palsy– Minor wound complications
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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
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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
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SAPPHIRE TRIAL
• Symptomatic patients (28.8%)• Primary end point
(Death/Stroke/MI)– 16.8% stent group– 16.5% CEA group
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SAPPHIRE TRIAL
• Strengths– RCT– Aim for non-inferiority– Identical results for actually treated
pts
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SAPPHIRE TRIAL
• Weaknesses– Allocation to randomise– Early cessation of study– ?Affiliation of investigators
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Clinical Answers
• Does this pt require intervention?Yes
• What options exist?Carotid endarterectomyCarotid stenting
• How do these compare?Stenting with protection is not inferior