Objective: To determine the effect of endarterectomy on the primary prevention of ischemic stroke in patients with asymptomatic carotid artery stenosis.
Methods: In a prospective, randomized, multicenter trial 1659 patients with asymptomatic carotid stenosis of 60% or more were studied in two treatment arms (endarterectomy: n = 825; medical therapy: n = 834). Endpoints were: (1) ischemic stroke in the vascular territory of the study artery, (2) any perioperative stroke or any perioperative death.
Results: The Kaplan-Meier 5-year-risk estimation showed a relative risk reduction of 53% (confidence interval: 22%-72%) for patients in the surgical arm. The combined perioperative morbidity and mortality rate was 2.3%.
Conclusion: Endarterectomy of asymptomatic carotid artery stenosis performed with a perioperative complication rate of less than 3% reduces the 5-year risk of ipsilateral stroke.