Carotid Artery Stenosis with Asymptomatic Narrowing: Operation Versus Aspirin "CASANOVA"

Completed

Phase N/A Results

Trial Description

To compare the efficacy of carotid endarterectomy plus medical treatment with medical treatment alone.

Interventions

Trial Design

Randomized, controlled, multicenter trial of 410 patients.

Patient Involvement

In group A, 206 patients with unilateral and bilateral stenosis had surgery unilaterally or bilaterally, respectively. In group B, 160 patients with unilateral stenosis had no initial surgery, whereas those with bilateral stenosis had surgery on the more affected side. Patients were operated on during the 3-year follow-up period if one of the following events occurred: development of a stenosis exceeding 90%; development of a bilateral internal carotid artery stenosis greater than 50% (operation on the more affected side); transient ischemic attack in the region supplied by the internal carotid artery with a stenosis of the artery >50%; development of an internal carotid stenosis greater than 50% contralateral to the operated side or restenosis greater than 50% in group A. All patients were treated with 330 mg acetylsalicylic acid and 75 mg dipyridamole three times daily.

Outcomes

Type Measure Time Frame Safety Issue
Primary Ischemic neurologic deficit exceeding 24 hours or death due to surgery or stroke. Follow-up of at least 3 years.

Sponsors

Bundesministerium fur Forschung und Technologie (BMFT)