To compare the efficacy of carotid endarterectomy (CAE) performed in conjunction with best medical treatment (BMT) with that of BMT alone in prolonging stroke-free survival time in patients with asymptomatic carotid stenosis.
- Endarterectomy, carotid (CEA)Procedure/Surgery
Intervention Desc: Surgical therapy to remove atherosclerotic plaque in narrowed carotid arteries.
International, multi-center, prospective, randomized trial.
Prior to enrollment, all patients will undergo Duplex sonography and a clinical interview. Eligible patients will be randomized to receive either BMT or BMT combined with CEA. Patients in the BMT group will receive as many of the following treatments as are indicated: smoking cessation counseling and treatment, antihypertensives (if blood pressure is consistently > 160/100 mmHg), screening and treatment for diabetes, screening and treatment for coronary artery disease, treatment for hyperlipidemia (if cholesterol is > 5.0 mmol/L), and anticoagulant or antiplatelet drugs. Patients in the BMT/CAE group will receive the same medical treatment as the BMT cohort, and will also undergo CAE as soon as possible after enrollment. All patients will undergo repeat carotid duplex scans and clinical interviews at 4 months post-randomization and annually thereafter, for a period of 5 years.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Mortality rate, incidence of stroke, and carotid stenosis (measured by Duplex sonography) at 4 months, 1, 2, 3, 4, and 5 years post-randomization.|