Prospective randomized trial of carotid endarterectomy with polytetrafluoroethylene versus collagen-impregnated dacron (Hemashield) patching: late follow-up

OBJECTIVE: To compare the late clinical outcome and incidence of recurrent stenosis after carotid endarterectomy (CEA) with polytetrafluoroethylene (PTFE) versus Hemashield patching. SUMMARY BACKGROUND DATA: Several randomized trials have confirmed the advantages of patching over primary closure when performing CEA. METHODS: Two hundred CEAs (180 patients) were randomized into 100 with PTFE patching and 100 with Hemashield. All patients underwent postoperative color duplex ultrasounds at 1, 6, and 12 months, and every year thereafter. The mean follow-up was 26 months. Kaplan-Meier analysis was used to estimate the risk of re-stenosis, stroke, and stroke-free survival. A multivariate analysis of various risk factors was also done. RESULTS: Demographic and clinical characteristics were similar in both groups. The incidence of all ipsilateral strokes (early and late) was 8% (7% perioperative) for Hemashield versus 0% for PTFE patching. Both groups had similar mortality rates. The cumulative stroke-free rates at 6, 12, 24, and 36 months were 93%, 93%, 93%, and 89% for Hemashield versus 100%, 100%, 100%, and 100% for PTFE patching. The cumulative stroke-free survival rates at 6, 12, 24, and 36 months were 90%, 89%, 87%, and 79% for Hemashield versus 98%, 98%, 92%, and 92% for PTFE patching. Kaplan-Meier analysis also showed that freedom from 50% or greater re-stenosis at 6, 12, 24, and 36 months was 89%, 81%, 73%, and 66% for Hemashield versus 100%, 100%, 100%, and 92% for PTFE. Similarly, the freedom from 70% or greater re-stenosis at 6, 12, 24, and 36 months was 93%, 91%, 86%, and 78% for Hemashield versus 100%, 100%, 100%, and 100% for PTFE. Univariate and multivariate analyses of demographic and preoperative risk factors showed that only Hemashield was significantly associated with a higher incidence of 70% or greater recurrent stenosis. CONCLUSIONS: PTFE patching was superior to Hemashield in lowering the incidence of postoperative ipsilateral strokes and late recurrent stenosis.