Carotid endarterectomy with a polyurethane patch versus primary closure: a prospective randomized study.

INTRODUCTION: The use of synthetic patch angioplasty during carotid endarterectomy (CEA) has been advocated to reduce restenosis, stroke, and death, but the type of material used is still being debated. This study compared rate of restenosis, neurologic events, and perioperative death in patients undergoing CEA with primary closure versus polyester urethane patch closure.

PATIENTS AND METHODS: In a prospective randomized study, we compared patch angioplasty with polyester urethane (Vascular-patch, B. Braun Medical AG, Tuttlingen, Germany) to primary closure between February 1999 and March 2002 in 404 operations. Early (30-day) stroke and mortality rate, long-term restenosis, and neurologic events were compared in the two groups during 2.5 to 5 years of follow-up (median follow-up, 2 years).

RESULTS: Primary closure was used in 216 operations, and patch angioplasty was used in 206. Clamping time was significantly shorter in the primary closure group ( P < .001). Perioperative mortality and neurologic events were similar in both groups (1.9% vs 3.9%, P = .21, odds ratio [OR], 2.1; 95% confidence interval [CI], 0.56 to 9.85). The rate of residual stenosis (> or =50%) at 0 or 3-month follow-up was significantly lower in the patch group (2 operations, 1.1%) compared with the primary closure group (17 operations, 8.9%) ( P = .001, OR, 0.114; 95% CI, 0.026 to 0.5). Multivariable logistic regression showed that only primacy closure was found to influence residual stenosis. Restenosis of 70% was significantly less in the patch angioplasty group (2.2% vs 8.6%) ( P = . 01, hazard ratio, 0.246; 95% CI, 0.08 to 0.75). No correlation was found between restenosis and gender, preoperative symptoms, or risk factors.

CONCLUSIONS: Patch angioplasty with polyester urethane significantly reduced the restenosis rate ( P = . 01) compared with primary closure. Even though clamping time was longer, patching was not associated with more perioperative complications.