Background Carotid stenting is less invasive than endarterectomy,but it is unclear whether it is as safe in patients with symptomaticcarotid-artery stenosis.
Methods We conducted a multicenter, randomized, noninferioritytrial to compare stenting with endarterectomy in patients witha symptomatic carotid stenosis of at least 60%. The primaryend point was the incidence of any stroke or death within 30days after treatment.
Results The trial was stopped prematurely after the inclusionof 527 patients for reasons of both safety and futility. The30-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 deathafter stenting as compared with endarterectomy was 2.5 (95%CI, 1.2 to 5.1). The 30-day incidence of disabling stroke ordeath was 1.5% after endarterectomy (95% CI, 0.5 to 4.2) and3.4% after stenting (95% CI, 1.7 to 6.7); the relative riskwas 2.2 (95% CI, 0.7 to 7.2). At 6 months, the incidence ofany stroke or death was 6.1% after endarterectomy and 11.7%after stenting (P=0.02). There were more major local complicationsafter stenting and more systemic complications (mainly pulmonary)after endarterectomy, but the differences were not significant.Cranial-nerve injury was more common after endarterectomy thanafter stenting.
Conclusions In this study of patients with symptomatic carotidstenosis of 60% or more, the rates of death and stroke at 1and 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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