title: 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].).
authors.affiliation: Hôpitaux Sainte-Anne, Université René Descartes, Paris, France. jl.mas@ch-sainte-anne.fr
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Mas
authors.forename: Gilles
authors.initials: G
authors.lastname: Chatellier
authors.forename: Bernard
authors.initials: B
authors.lastname: Beyssen
authors.forename: Alain
authors.initials: A
authors.lastname: Branchereau
authors.forename: Thierry
authors.initials: T
authors.lastname: Moulin
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Becquemin
authors.forename: Vincent
authors.initials: V
authors.lastname: Larrue
authors.forename: Michel
authors.initials: M
authors.lastname: Lièvre
authors.forename: Didier
authors.initials: D
authors.lastname: Leys
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Bonneville
authors.forename: Jacques
authors.initials: J
authors.lastname: Watelet
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Pruvo
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Albucher
authors.forename: Alain
authors.initials: A
authors.lastname: Viguier
authors.forename: Philippe
authors.initials: P
authors.lastname: Piquet
authors.forename: Pierre
authors.initials: P
authors.lastname: Garnier
authors.forename: Fausto
authors.initials: F
authors.lastname: Viader
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Touzé
authors.forename: Maurice
authors.initials: M
authors.lastname: Giroud
authors.forename: Hassan
authors.initials: H
authors.lastname: Hosseini
authors.forename: Jean-Christophe
authors.initials: JC
authors.lastname: Pillet
authors.forename: Pascal
authors.initials: P
authors.lastname: Favrole
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Neau
authors.forename: Xavier
authors.initials: X
authors.lastname: Ducrocq
mesh_terms: D000368:Aged; D017130:Angioplasty; D016893:Carotid Stenosis / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D016894:Endarterectomy, Carotid / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D009203:Myocardial Infarction / Q000453:epidemiology; D012306:Risk; D015607:Stents / Q000009:adverse effects; D020521:Stroke / Q000453:epidemiology / Q000401:mortality; D016896:Treatment Outcome