Critical Appraisal of the European CAS Trials

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Presentation transcript:

Critical Appraisal of the European CAS Trials John. J Ricotta MD FACS Professor Surgery Georgetown University Chair of Surgery Washington Hospital Center CRT 2012

I have no real or apparent conflicts of interest to report. John J. Ricotta, MD I have no real or apparent conflicts of interest to report.

“What’s wrong with this picture?” Perspective Interventionalists - CREST showed equivalence, MACE is what is important, European trials are fatally flawed Surgeons – Stroke and death is what is important, not minor MI, major trials favor CEA for reduction of S/D, CREST results are great but not “real world “ for CAS Neurologists – BMT has reduced stroke risk and direct BMT comparisons are required

Questions What are the proper endpoints for comparisons between CAS and CEA? Where CEA and CAS fairly compared in the European trials? How applicable are the trial results to the real world ?

Proper Endpoints MACE vs. Stroke/Death MACE treats all events as equivalent - Stroke, Death and MI all have different clinical implications, weighting was not used The purpose of Carotid revascularization is to prevent stroke with minimal mortality and good long term outcome 4 yr mortality after any MI in CREST was 19.6% but was 20% after any stroke – both may be markers or reduced late survival

European Symptomatic Trials

European Trials EVA 3-S, SPACE, ICSS Limited to Sx pts - 3423 (1688 CAS, 1664 CEA) Endpoints were Stroke and Death not MI Operators did not have to have extensive CAS experience – although they did have to have EV experience EPD not mandated : EVA 3S -92%, ICSS – 72%, SPACE - 27% no relation of EPD and stroke

Are the European Trials an Aberration? How do the results compare with CREST? - only 52% of interventionists selected - lead in phase to assure AHA standards - 96% EPD use How do the results compare with CAS registries?

30 D Stroke and Death in Normal Risk Symptomatic Trial Pts # CAS Pts CAS S/D # CEA Pts CEA S/D Risk Reduction SPACE 598 7.7% 584 6.5% 1.18 EVA – 3S 261 9.6% 259 3.9%* 2.48 ICSS 828 7.1% 821 3.4%* 2.09 CREST 668 6.0%* 653 3.2%* 1.86 TOTAL 2356 7.3% 2317 4.2%* 1.75 (1.26-2.42)

30 Day Stroke and Death Rates in Multicenter Registries 11 Multicenter Registries - 3353 Symptomatic Patients - Stroke and Death Rate 7.4% (CI 6.0-9.0) Mark Grant MD MPH presented to MEDCAC Jan 26, 2011 Systematic review of 42 studies (4910 Sx pts) - Stroke/Death rate 7.3% (CI:6.3- 9.1) Touze E et al. Stroke 2009;40:e683-93.

Annual CAS volume CMS Data (Nailamothu BK et al, JAMA 2011;306: 1338-43) 24701 CAS procedures 2339 operators Median 3 CAS/yr 11.6% operators performed > 12 CAS /yr

Conclusions There are design flaws in the European Trials comparing CAS and CEA in Symptomatic Pts However their results are consistent with CREST, i.e. stroke and death RR of almost 2 fold with CEA vs. CAS CREST is only trial where CAS meets AHA guidelines for S/D in Sx pts European trials may mirror the real world experience of CAS in both operator volume and results

Stenting in Symptomatic Patients (Rothwell PM, Lancet Neurology 2009;8:871 “… The routine use of stenting in patients with recent symptoms of carotid stenosis in patients who are candidates for carotid Endarterectomy can no longer be justified”