Prospective Randomized Trial of Carotid Endarterectomy With Polytetrafluoroethylene Versus Collagen-Impregnated Dacron (Hemashield) Patchingcolon; Late Follow-Up

摘要

ObjectiveTo compare the late clinical outcome and incidence of recurrent stenosis after carotid endarterectomy (CEA) with polytetrafluoroethylene (PTFE) versus Hemashield patching.Summary Background DataSeveral randomized trials have confirmed the advantages of patching over primary closure when performing CEA.MethodsTwo 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.ResultsDemographic and clinical characteristics were similar in both groups. The incidence of all ipsilateral strokes (early and late) was 8percnt; (7percnt; perioperative) for Hemashield versus 0percnt; for PTFE patching. Both groups had similar mortality rates. The cumulative stroke-free rates at 6, 12, 24, and 36 months were 93percnt;, 93percnt;, 93percnt;, and 89percnt; for Hemashield versus 100percnt;, 100percnt;, 100percnt;, and 100percnt; for PTFE patching. The cumulative stroke-free survival rates at 6, 12, 24, and 36 months were 90percnt;, 89percnt;, 87percnt;, and 79percnt; for Hemashield versus 98percnt;, 98percnt;, 92percnt;, and 92percnt; for PTFE patching. Kaplan-Meier analysis also showed that freedom from 50percnt; or greater re-stenosis at 6, 12, 24, and 36 months was 89percnt;, 81percnt;, 73percnt;, and 66percnt; for Hemashield versus 100percnt;, 100percnt;, 100percnt;, and 92percnt; for PTFE. Similarly, the freedom from 70percnt; or greater re-stenosis at 6, 12, 24, and 36 months was 93percnt;, 91percnt;, 86percnt;, and 78percnt; for Hemashield versus 100percnt;, 100percnt;, 100percnt;, and 100percnt; for PTFE. Univariate and multivariate analyses of demographic and preoperative risk factors showed that only Hemashield was significantly associated with a higher incidence of 70percnt; or greater recurrent stenosis.ConclusionsPTFE patching was superior to Hemashield in lowering the incidence of postoperative ipsilateral strokes and late recurrent stenosis.