Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis.

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].).

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@article{Mas2006EndarterectomyVS, title={Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis.}, author={J-L Mas and Gilles Chatellier and Bernard M. Beyssen and Alain Branchereau and Thierry Moulin and Jean-Pierre Becquemin and Vincent Larrue and Michel M Li{\`e}vre and Didier Leys and Jean-François Bonneville and Jacques Watelet and Jean-Pierre Pruvo and Jean-François Albucher and Alain Viguier and Philippe Piquet and Pierre Garnier and Fausto Viader and Emmanuel Touz{\'e} and Maurice E Giroud and Hassan Hosseini and Jean-Christophe Pillet and Pascal Favrole and Jean - Philippe Neau and Xavier Ducrocq}, journal={The New England journal of medicine}, year={2006}, volume={355 16}, pages={1660-71} }