1. The safety and efficacy of a paclitaxel-eluting wrap for preventing peripheral bypass graft stenosis: a 2-year controlled randomized prospective clinical study.
- Author
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Mátyás L, Berry M, Menyhei G, Tamás L, Acsády G, Cuypers P, Halmos F, de Vries AC, Forgacs V, Ingenito G, and Avelar R
- Subjects
- Amputation, Surgical, Anastomosis, Surgical, Blood Vessel Prosthesis Implantation adverse effects, Cardiovascular Agents adverse effects, Europe, Female, Femoral Artery physiopathology, Humans, Male, Middle Aged, Netherlands Antilles, Paclitaxel adverse effects, Peripheral Vascular Diseases physiopathology, Polytetrafluoroethylene, Popliteal Artery physiopathology, Prospective Studies, Prosthesis Design, Reoperation, Time Factors, Treatment Outcome, Vascular Patency, Bandages, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Cardiovascular Agents administration & dosage, Femoral Artery surgery, Paclitaxel administration & dosage, Peripheral Vascular Diseases surgery, Popliteal Artery surgery
- Abstract
Objectives: 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)., Design: Prospective, randomized, controlled, multicentre, 2-year clinical study conducted in adults scheduled to undergo femoropopliteal peripheral bypass surgery with a polytetrafluoroethylene (PTFE) graft., Materials and Methods: 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., Results: 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)., Conclusions: 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.
- Published
- 2008
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