Prospective randomized trial of bilateral carotid endarterectomies: primary closure versus patching.

BACKGROUND AND PURPOSE

Although several studies have compared the results of carotid endarterectomy (CEA) with primary closure (PC) versus patch closure, none have compared the outcome of bilateral CEAs with patch versus PC performed on the same patient. This prospective randomized study compares the clinical outcome and incidence of recurrent stenosis (>/=80%) for CEA with PC versus patch closure in patients with bilateral CEAs.

METHODS

This study includes 74 patients with bilateral CEAs with PC on one side and patching on the other. Patients were randomized to sequential operative treatment of either patching/PC or PC/patching. Postoperative duplex ultrasounds and clinical follow-up were done at 1, 6, and 12 months and every year thereafter. A Kaplan-Meier analysis was used to estimate the risk of significant restenosis (>/=80%).

RESULTS

Demographic characteristics and the mean operative diameter of the internal carotid artery were similar for both PC and patching. The mean follow-up was 29 months (range, 6 to 65 months). The incidence of ipsilateral stroke was 4% for PC versus 0% for patching. PC had a significantly higher incidence of neurological complications (transient ischemic attacks and stroke combined) than patching (12% versus 1%; P=0.02). Operative mortality was 0%. PC had a higher incidence of recurrent stenosis (22% versus 1%; P<0.003) and total internal carotid artery occlusion (8% versus 0%; P=0.04) than patching. Restenoses necessitating a repeated CEA were also higher for PC (14%) than for patching (1%; P=0.01). The Kaplan-Meier analysis showed that patching had a significantly better cumulative patency rate than PC (P<0.01). This analysis also showed that freedom from recurrent stenosis at 24 months was 75% for PC and 98% for patching.

CONCLUSIONS

Patch closure is less likely than PC to cause ipsilateral stroke, transient ischemic attacks, and recurrent carotid stenosis. The higher rate of unilateral recurrent stenosis may suggest that local factors play a more significant role than systemic factors in the etiology of recurrent carotid stenosis.