To determine the efficacy of carotid endarterectomy combined with the best medical care compared to the best medical care alone for patients with ipsilateral symptomatic carotid stenosis.
- Endarterectomy, carotid (CEA)Procedure/Surgery
Intervention Desc: Surgical therapy to remove atherosclerotic plaque in narrowed carotid arteries.
Randomized, unblinded, controlled, trial of 189 male patients at 16 centers.
Patients were randomized to receive carotid endarterectomy within 3 days of randomization in addition to best medical treatment or best medical treatment alone. All patients received aspirin (325 mg) once daily. If a primary outcome event occurred in the nonsurgical group, surgical therapy was offered at the discretion of the physician and the patients were followed-up outside of the study for 36 months.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Death from any cause within 30 days, cerebral/retinal infarction or crescendo transient ischemic attack (TIA) in the vascular distribution of the original symptoms. Assessments were made 4 weeks after randomization, every 13 weeks for the first year and every 26 weeks for years 2 and 3.|
|Secondary||Death of cause other than ipsilateral stroke, withdrawal from the study, severe adverse reaction to aspirin or symptoms necessitating carotid endarterectomy on the contralateral side.|