London, United Kingdom 2013 8 Large clinical trials (RCTs) B 11:40 - 11:50 Is carotid artery stenting as durable as carotid surgery? Long-Term Results from the Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Steno-sis (EVA-3S) trial. J.L. MAS1, G. CHATELLIER2 EVA-3S investigators Hôpital Sainte-Anne, Paris, FRANCE1,Hôpital Européen Georges Pompidou, Paris, FRANCE2 Background. We previously reported that in patients in the EVA-3S trial, the rate of any stroke or death within 30 days after the procedure was higher with stenting than with surgery. How-ever, after the 30-day period, the risk of ipsilateral stroke was low and similar in both treatment groups, suggesting that carotid stenting is as effective as carotid surgery for medium-term pre-vention of ipsilateral stroke, at least for the first few years after the perioperative period. We now report on long-term (up to 10 years) follow-up of patients included in this study. Methods. EVA-3S is a multicentre (30 centres in France), randomized, open, assessor-blinded, non-inferiority trial of stenting versus endarterectomy in 527 patients with recently symptom-atic carotid stenosis of at least 60%. This trial is registered with ClinicalTrials.gov, number NCT00190398. Patients were included between November 2000 and September 2005 and the present study was conducted between December 1, 2011 and May 31, 2012. Vital status was ascertained through municipal death registries. Survivors at the time of the follow-up study were asked to participate in a structured interview. The interview schedule included questions aimed at detecting a new stroke, TIA, acute coronary syndrome, or revascularization proce-dures, including carotid, coronary or peripheral procedures. The modified Rankin Scale was assessed during the interview. Patients were asked to have carotid ultrasound performed and re-ports of all carotid examinations were collected. For patients who had died, physicians who had been in charge of the patients were contacted to obtain information about occurrence of out-come events before death and the cause of death. For patients who had died or were suspected of having had a recurrent stroke or other vascular event, all of the available clinical information and results of investigations obtained from records held by hospitals and physicians in private practice were independently reviewed and adjudicated by two physicians, blinded to treatment assignments. Results will be presented during the conference. Cerebrovasc Dis 2013; 35 (suppl 3)1-854 109 7 Large clinical trials (RCTs) B 11:30 - 11:40 Restenosis after carotid artery stenting versus endarterectomy during long-term fol-low- up in the International Carotid Stenting Study (ICSS) L.H. Bonati1, J. Dobson2, R.L. Featherstone3, D. Doig4, M.M. Brown5 ICSS Investigators Department of Brain Repair and Rehabilitation, UCL Institute of Neurology, London, UNITED KINGDOM1,London School of Hygiene and Tropical Medicine, London, UNIT-ED KINGDOM2, Department of Brain Repair and Rehabilitation, UCL Institute of Neurology, London, UNITED KINGDOM3, Department of Brain Repair and Rehabilitation, UCL Institute of Neurology, London, UNITED KINGDOM4, Department of Brain Repair and Rehabilitation, UCL Institute of Neurology, London, UNITED KINGDOM5 Background: Restenosis is a potential disadvantage of carotid artery stenting (CAS) versus endarterectomy (CEA) and might cause recurrent stroke. No trial has reported restenosis rates beyond the first few years. We therefore analysed restenosis and recurrent stroke rates in the International Carotid Stenting Study (ICSS). Methods: 1713 patients with symptomatic carotid stenosis (≥50%) were randomly allocated to CAS or CEA. Patients were followed with carot-id duplex ultrasound at baseline, 1 and 6 months after treatment and then annually for up to 10 years. Restenosis was defined as severe residual or recurrent stenosis ≥70% on the basis of velocity measurements without correction for treatment arm, and analysed using interval-cen-sored models. Results: In 1649 patients (CAS 828, CEA 821) treatment was initiated as ran-domly allocated. 1583 of these patients (CAS 789, CEA 794) were followed-up with ultrasound for a median of 4.0 (interquartile range: 2.3-5.0) years after treatment. Severe carotid restenosis (≥70%) or occlusion occurred in 84 patients in the CAS arm and in 60 patients in the CEA arm (hazard ratio 1.43, 95% CI 1.02-1.99, p=0.034), with cumulative 5-year incidences of 12.5% (SE 1.4%) and 8.9% (SE 1.1%), respectively. When patients with aborted treatment were ex-cluded, there was no difference in restenosis rates between CAS (70 of 737 patients) and CEA (60 of 793 patients, HR 1.25, 95% CI 0.89-1.77, p=0.20). Among patients in whom restenosis was diagnosed within the first year of treatment (90 patients, CAS: n=52, CEA: n=38) there was no increase in risk of future ipsilateral stroke. Conclusion: There appears to be a small in-crease in rates of severe restenosis after CAS compared with CEA which might be partly attrib-utable to incomplete revascularisation during CAS. However, the risk of recurrent stroke does not appear to be increased among patients with restenosis. Routine ultrasound surveillance after revascularisation might not be warranted.
Karger_ESC London_2013
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