The Safety and Efficacy of a Paclitaxel-eluting Wrap for Preventing Peripheral Bypass Graft Stenosis: A 2-Year Controlled Randomized Prospective Clinical Study

Abstract

To compare the safety and efficacy of a bioresorbable paclitaxel-eluting wrap implanted with a synthetic vascular graft (treatment) versus the graft implanted alone (control). Prospective, randomized, controlled, multicentre, 2-year clinical study conducted in adults scheduled to undergo femoropopliteal peripheral bypass surgery with a polytetrafluoroethylene (PTFE) graft. Hundred and nine subjects were randomized 2:1 to treatment or control. All subjects were implanted with a 6mm expanded PTFE vascular graft; in addition, treated subjects had a 2.5 cm x 4 cm paclitaxel-eluting wrap (1.6 microg/mm(2)) placed around the distal graft anastomosis. The overall incidence of adverse events was similar in both groups. Treated subjects required fewer limb amputations than controls (15.5% vs 18.4%) and time to amputation for those that required amputation was twice as long (153 days vs 76 days). Among diabetics, this effect was pronounced with 13.8% of treated subjects requiring limb amputations compared with 23.5% of controls. Over the course of study, the diameter at the distal graft anastomosis was greater in treated subjects than in controls (difference of 2.1mm at 2 yr, p=0.03). The paclitaxel-eluting wrap maintained graft patency at the distal anastomosis and was safe to use in patients who had received a peripheral bypass PTFE graft.