A randomized trial of synthetic patch versus direct primary closure in carotid endarterectomy

OBJECTIVE: To define whether or not direct microscopic closure with or without the use of a vascular patch is advantageous in terms of clinical outcome and late vessel occlusion rates after microsurgical carotid endarterectomy. METHODS: Three hundred thirty-eight elective carotid endarterectomies in 315 patients were randomized to direct arteriotomy or closure with a polyester collagen-coated vascular patch. Ten procedures did not follow the randomization process because of technical difficulties and were excluded. Vessel patency (duplex ultrasound) and outcome were assessed during and immediately after surgery and at 4 and 12 months after surgery. RESULTS: Four-month ultrasound assessment (n = 321) identified five occluded vessels: two in the patch group (n = 149) and three in the direct closure group (n = 172). Six patients in the patch group had died or were significantly disabled at 4 months, compared with five in the direct closure group. At the 12-month assessment (n = 313), eight vessels had occluded: five from the patched group (n = 146) and three from the direct closure group (n = 167). Eight patients in the patch group had died or were significantly disabled, compared with four in the direct closure group. No statistically significant difference between the two groups in terms of vessel occlusion, morbidity, or mortality was seen (P > 0.1). CONCLUSION: No difference in vessel patency and clinical outcome has been identified after microscopic patch angioplasty and direct arteriotomy repair. The authors conclude that there is no benefit from the routine use of patch angioplasty in microscopic carotid endarterectomy.