Background and purpose: The Asymptomatic Carotid Atherosclerosis Study is a prospective, multicenter, randomized clinical trial of carotid endarterectomy for the treatment of asymptomatic hemodynamically significant stenosis. This report describes the selection process for participating surgeons in the trial.
Methods: The Surgical Management Committee established guidelines for minimal annual experience and maximum neurological morbidity and mortality for surgeons to qualify to participate in the study. For approval, a surgeon must perform at least 12 carotid endarterectomies per year. Based on a review of the surgeon's last 50 consecutive endarterectomies, the combined neurological morbidity and mortality rate must be no greater than 5% for all indications and no greater than 3% for endarterectomies performed on asymptomatic patients.
Results: One hundred sixty-four surgeons from 48 centers applied for approval: 117 were approved, 17 were rejected, and 30 were not reviewed. The 117 approved surgeons submitted a total of 5,641 endarterectomies with a combined mortality and neurological morbidity rate of 2.3% for the variety of indications for operation.
Conclusions: This overall experience with carotid endarterectomy is one of the largest series reported to date. The data from approved surgeons are well within the range of acceptable neurological morbidity and mortality rates recommended by the Stroke Council of the American Heart Association, which attests to the overall quality of the surgeons participating in the study.