Prospective Randomized Trial of Carotid Endarterectomy Contralateral to Carotid Artery Occlusion

Completed

Phase N/A Results

Trial Description

To analyze the results of surgery in patients with contralateral carotid artery occlusion in a randomized trial.

Interventions

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

Trial Design

Randomized trial of 357 patients.

Patient Involvement

Patients were randomized to receive carotid endarterectomy (CEA) with either primary closure (PC), polytetrafluoroethylene patching (PTFE) or vein patch closure. Before surgery, all patients underwent carotid color duplex ultrasound and angiographic studies to determine preoperative stenoses. On the basis of their angiographic/duplex data, patients were divided into 2 groups. Group A (49 CEAs) consisted of patients who underwent CEAs for significant ipsilateral internal carotid artery (ICA) stenosis (>50%) with a known contralateral ICA occlusion. Group B (350 CEAs) consisted of patients who underwent CEA of significant ipsilateral ICA stenosis without a contralateral occlusion. All patients were administered aspirin therapy (325 mg daily within 24 hours after the operation). Patients underwent clinical follow-up and immediate postoperative color duplex ultrasound scanning, which was repeated at 30 days, 6 months, 12 months, and every year thereafter.

Outcomes

Type Measure Time Frame Safety Issue
Primary Incidence of perioperative cerebrovascular accidents; incidence of reversible ischemic neurologic deficit (RIND); rate of perioperative and late stroke; rate of perioperative and late mortality.