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Original Article
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Volume 355:1660-1671 October 19, 2006 Number 16
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Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis
Jean-Louis Mas, M.D., Gilles Chatellier, M.D., Bernard Beyssen, M.D., Alain Branchereau, M.D., Thierry Moulin, M.D., Jean-Pierre Becquemin, M.D., Vincent Larrue, M.D., Michel Lièvre, M.D., Didier Leys, M.D., Ph.D., Jean-François Bonneville, M.D., Jacques Watelet, M.D., Jean-Pierre Pruvo, M.D., Ph.D., Jean-François Albucher, M.D., Alain Viguier, M.D., Philippe Piquet, M.D., Pierre Garnier, M.D., Fausto Viader, M.D., Emmanuel Touzé, M.D., Maurice Giroud, M.D., Hassan Hosseini, M.D., Ph.D., Jean-Christophe Pillet, M.D., Pascal Favrole, M.D., Jean-Philippe Neau, M.D., Xavier Ducrocq, M.D., for the EVA-3S Investigators

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ABSTRACT

Background Carotid stenting is less invasive than endarterectomy, but it is unclear whether it is as safe in patients with symptomatic carotid-artery stenosis.

Methods We conducted a multicenter, randomized, noninferiority trial to compare stenting with endarterectomy in patients with a symptomatic carotid stenosis of at least 60%. The primary end point was the incidence of any stroke or death within 30 days after treatment.

Results The trial was stopped prematurely after the inclusion of 527 patients for reasons of both safety and futility. The 30-day incidence of any stroke or death was 3.9% after endarterectomy (95% confidence interval [CI], 2.0 to 7.2) and 9.6% after stenting (95% CI, 6.4 to 14.0); the relative risk of any stroke or death after stenting as compared with endarterectomy was 2.5 (95% CI, 1.2 to 5.1). The 30-day incidence of disabling stroke or death was 1.5% after endarterectomy (95% CI, 0.5 to 4.2) and 3.4% after stenting (95% CI, 1.7 to 6.7); the relative risk was 2.2 (95% CI, 0.7 to 7.2). At 6 months, the incidence of any stroke or death was 6.1% after endarterectomy and 11.7% after stenting (P=0.02). There were more major local complications after stenting and more systemic complications (mainly pulmonary) after endarterectomy, but the differences were not significant. Cranial-nerve injury was more common after endarterectomy than after stenting.

Conclusions In this study of patients with symptomatic carotid stenosis of 60% or more, the rates of death and stroke at 1 and 6 months were lower with endarterectomy than with stenting. (ClinicalTrials.gov number, NCT00190398 [ClinicalTrials.gov] .)


Source Information

From Hôpitaux Sainte-Anne (J.-L.M., B.B., E.T.) and Europeén Georges Pompidou (G.C.), Université René Descartes, Paris; Hôpitaux La Timone (A.B.) and Sainte-Marguerite (P.P.), Université de la Méditerranée, Marseille; Hôpital Jean Minjoz, Université de Franche-Comté, Besançon (T.M., J.-F.B.); Hôpital Henri Mondor, Université Paris-Val-de-Marne, Créteil (J.-P.B., H.H.); Hôpitaux Rangueil (V.L., A.V.) and Purpan (J.-F.A.), Université Paul Sabatier, Toulouse; Université Claude Bernard, Lyon (M.L.); Hôpital Roger Salengro, Université du Droit et de la Santé, Lille (D.L., J.-P.P.); Hôpital Charles Nicolle, Université de Rouen, Rouen (J.W.); Hôpital de Bellevue, Université Jean Monnet, Saint-Etienne (P.G.); Hôpital Côte de Nacre, Université de Caen, Caen (F.V.); Hôpital Général, Université de Bourgogne, Dijon (M.G.); Nouvelles Cliniques Nantaises, Nantes (J.-C.P.); Hôpital Lariboisière, Université Denis Diderot, Paris (P.F.); Hôpital La Milétrie, Université de Poitiers, Poitiers (J.-P.N.); and Hôpital Saint-Julien Université Henri Poincaré, Nancy (X.D.) — all in France.

Address reprint requests to Dr. Mas at the Service de Neurologie, Hôpital Sainte-Anne, 1 Rue Cabanis, 75674 Paris Cedex 14, France, or at jl.mas{at}ch-sainte-anne.fr.

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Related Letters:

Endarterectomy versus Stenting for Carotid Stenosis
Bonvini R. F., Righini M., Hamon M., Riddell J. W., Maree A. O., Rosenfield K. A., Mas J.-L., Chatellier G., the EVA-3S Investigators
Extract | Full Text | PDF  
N Engl J Med 2007; 356:305-307, Jan 18, 2007. Correspondence

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