Role of carotid endarterectomy in asymptomatic carotid stenosis: a Veterans Administration Cooperative Study.

Completed

Phase N/A Results

Trial Description

To determine the effect of carotid endarterectomy combined with aspirin therapy compared to aspirin therapy alone in patients with asymptomatic carotid stenosis.

Interventions

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

Trial Design

Randomized trial of 444 men conducted at 10 VA medical centers.

Patient Involvement

Patients from each of two clinical categories (group II: unilateral symptomatic lesions and contralateral asymptomatic carotid stenosis , group III: incidental cervical bruits, with or without global symptoms and positive noninvasive screening tests) were randomly assigned to optimal medical treatment including antiplatelet medication (aspirin 650 mg, bid.) plus carotid endarterectomy or optimal medical treatment alone.

Outcomes

Type Measure Time Frame Safety Issue
Primary Transient ischemic attack (TIA), stroke or stroke death. Follow-up consists of clinical visits at 13-week intervals during the first year and at 26-week intervals during years 2-5.