Long-term follow-up study of endarterectomy versus angioplasty in patients with symptomatic severe carotid stenosis trial

Stroke. 2014 Sep;45(9):2750-6. doi: 10.1161/STROKEAHA.114.005671. Epub 2014 Jul 31.


Background and purpose: We aimed at comparing the long-term benefit-risk balance of carotid stenting versus endarterectomy for symptomatic carotid stenosis.

Methods: Long-term follow-up study of patients included in Endarterectomy Versus Angioplasty in Patients With Symptomatic Severe Carotid Stenosis (EVA-3S), a randomized, controlled trial of carotid stenting versus endarterectomy in 527 patients with recently symptomatic severe carotid stenosis, conducted in 30 centers in France. The main end point was a composite of any ipsilateral stroke after randomization or any procedural stroke or death.

Results: During a median follow-up of 7.1 years (interquartile range, 5.1-8.8 years; maximum 12.4 years), the primary end point occurred in 30 patients in the stenting group compared with 18 patients in the endarterectomy group. Cumulative probabilities of this outcome were 11.0% (95% confidence interval, 7.9-15.2) versus 6.3% (4.0-9.8) in the endarterectomy group at the 5-year follow-up (hazard ratio, 1.85; 1.00-3.40; P=0.04) and 11.5% (8.2-15.9) versus 7.6% (4.9-11.8; hazard ratio, 1.70; 0.95-3.06; P=0.07) at the 10-year follow-up. No difference was observed between treatment groups in the rates of ipsilateral stroke beyond the procedural period, severe carotid restenosis (≥70%) or occlusion, death, myocardial infarction, and revascularization procedures.

Conclusions: The long-term benefit-risk balance of carotid stenting versus endarterectomy for symptomatic carotid stenosis favored endarterectomy, a difference driven by a lower risk of procedural stroke after endarterectomy. Both techniques were associated with low and similar long-term risks of recurrent ipsilateral stroke beyond the procedural period.

Clinical trial registration url: http://www.clinicaltrials.gov. Unique identifier: NCT00190398.

Keywords: atherosclerosis; carotid stenosis; endarterectomy, carotid.

Publication types

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

MeSH terms

  • Aged
  • Angioplasty / methods*
  • Carotid Stenosis / surgery*
  • Endarterectomy / methods*
  • Female
  • Follow-Up Studies
  • France
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Risk
  • Stents
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT00190398