Endarterectomy Versus Stenting in Patients With Symptomatic Severe Carotid Stenosis

N Engl J Med. 2006 Oct 19;355(16):1660-71. doi: 10.1056/NEJMoa061752.

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].).

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Angioplasty
  • Carotid Stenosis / mortality
  • Carotid Stenosis / surgery
  • Carotid Stenosis / therapy*
  • Endarterectomy, Carotid* / adverse effects
  • Female
  • Follow-Up Studies
  • Humans
  • Incidence
  • Male
  • Myocardial Infarction / epidemiology
  • Risk
  • Stents* / adverse effects
  • Stroke / epidemiology
  • Stroke / mortality
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT00190398