Polytetrafluoroethylene versus human umbilical vein in above-knee femoropopliteal bypass: six-year results of a randomized clinical trial.

In a prospective, randomized trial 6 mm polytetrafluoroethylene (PTFE) and 6 mm human umbilical vein (HUV) were compared in above-knee femoropopliteal bypass grafting. In claudicants a prosthetic graft was used intentionally, in limb-salvage cases only when autologous vein was insufficient. Ninety-six extremities were randomized (49 PTFE and 47 HUV). Operative indication was disabling claudication in 77 and limb salvage in 19 extremities. The two groups were comparable as to preoperative risk factors and operative and postoperative treatment. Median follow-up was 76 months (range 47 to 91 months), during which 23 patients died of nonrelated causes with functioning grafts. Thirty-eight grafts failed (33 because of occlusion and five for other reasons). At 6 years the primary patency rate was 38.7% in the PTFE group and 71.4% in the HUV group (p < 0.001). Corresponding rates for secondary patency at 6 years were 51.4% and 76.4% (p < 0.005).