Carotid Endarterectomy and Prevention of Cerebral Ischemia in Symptomatic Carotid Stenosis "VACSP 309"

Completed

Phase N/A Results

Trial Description

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.

Interventions

  • Endarterectomy, carotid (CEA)Procedure/Surgery
    Intervention Desc: Surgical therapy to remove atherosclerotic plaque in narrowed carotid arteries.

Trial Design

Randomized, unblinded, controlled, trial of 189 male patients at 16 centers.

Patient Involvement

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.

Outcomes

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.

Sponsors

Department of Veterans Affairs Cooperative Studies Program, VA Medical Research Service