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

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.