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RESEARCH PRODUCT

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

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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.