Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis
Jean-Louis Mas, Gilles Chatellier, Bernard Beyssen, Alain Branchereau, Thierry Moulin, Jean-Pierre Becquemin, Vincent Larrue, Michel Lièvre, Didier Leys, Jean-François Bonneville, Jacques Watelet, Jean-Pierre Pruvo, Jean-François Albucher, Alain Viguier, Philippe Piquet, Pierre Garnier, Fausto Viader, Emmanuel Touzé, Maurice Giroud, Hassan Hosseini, Jean-Christophe Pillet, Pascal Favrole, Jean-Philippe Neau, Xavier Ducrocq, EVA-3S Investigators, Jean-Louis Mas, Gilles Chatellier, Bernard Beyssen, Alain Branchereau, Thierry Moulin, Jean-Pierre Becquemin, Vincent Larrue, Michel Lièvre, Didier Leys, Jean-François Bonneville, Jacques Watelet, Jean-Pierre Pruvo, Jean-François Albucher, Alain Viguier, Philippe Piquet, Pierre Garnier, Fausto Viader, Emmanuel Touzé, Maurice Giroud, Hassan Hosseini, Jean-Christophe Pillet, Pascal Favrole, Jean-Philippe Neau, Xavier Ducrocq, EVA-3S Investigators
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].).
Copyright 2006 Massachusetts Medical Society.
Source: PubMed