Dacron or PTFE for Above-knee Femoropopliteal Bypass. A Multicenter Randomised Study

• Published in: European journal of vascular and endovascular surgery 2007-07, Vol.34 (1), p.44-49
• Main Authors: Jensen, L.P, Lepäntalo, M, Fossdal, J.E, Røder, O.C, Jensen, B.S, Madsen, M.S, Grenager, O, Fasting, H, Myhre, H.O, Bækgaard, N, Nielsen, O.M, Helgstrand, U, Schroeder, T.V
• Format: Article
• Language: English
• Subjects: Above-knee; Adult; Aged; Aged, 80 and over; Angiography; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation - instrumentation; Claudication; Critical ischemia; Dacron; Female; Femoral Artery - diagnostic imaging; Femoral Artery - surgery; Femoro-popliteal bypass; Follow-Up Studies; Humans; Ischemia - diagnosis; Ischemia - physiopathology; Ischemia - surgery; Leg - blood supply; Male; Middle Aged; Peripheral bypass; Polyethylene Terephthalates; Polytetrafluoroethylene; Popliteal Artery - diagnostic imaging; Popliteal Artery - surgery; Prosthesis Design; PTFE; Retrospective Studies; Surgery; Treatment Outcome; Ultrasonography; Vascular Patency
• ISSN: 1078-5884; 1532-2165
• DOI: 10.1016/j.ejvs.2007.01.016

Objectives To compare polytetrafluorethylene (PTFE) and polyester grafts (Dacron) for above knee femoropopliteal bypass. Design Multicenter randomised clinical trial. Material and Methods 427 patients were randomised between 6 mm Dacron (Uni-Graft®, B. Braun Melsungen AG, 34212 Melsungen, Germany) and PTFE (Goretex®, W. L. Gore & Ass. Inc., Newark DE 19711, USA) above-knee femoropopliteal bypass grafts within 13 centres in Denmark ( n = 261), Norway ( n = 113) & Finland ( n = 53) between 1993 and 1998. Fourteen (3%) patients were excluded, leaving 413 patients with 208 Dacron and 205 PTFE grafts for analysis. Age, gender, indication (claudication: 65%), run-off (2 or 3 vessels: 76%), diabetes (17%) and hypertension (31%) as well as cerebrovascular (9%) and cardiac (33%) risks were evenly distributed. Patients were followed postoperatively at 1, 12 and 24 months. Patency assessment was based on ankle-brachial pressures or imaging in case of doubt. Results The two-year primary patency rates for Dacron and PTFE were 70% and 57% ( p = 0.02), whereas the secondary patency rates were 76% and 65% ( p = 0.04), respectively. Primary patency at two years was significantly influenced by the number of patent crural vessels (two or three 67%, one 50%, p = 0.01). Amputations at two years, major in 4% and minor in 3%, 30-days mortality and complications (wound infections: 3% and other wound complications: 13%) occurred equally frequent in both groups. At two years, patients treated for critical limb ischemia had a major amputation more often than patients operated on for intermittent claudication, 10 and 3 respectively ( p = 0.003), and had higher mortality rates, 20% and 8% respectively ( p = 0.001). Conclusion This trial confirms that Dacron is at least as durable as PTFE for above-knee bypass procedures, and might even be superior.