A comparative evaluation of polytetrafluoroethylene, umbilical vein, and saphenous vein bypass grafts for femoral-popliteal above-knee revascularization: a prospective randomized Department of Veterans Affairs cooperative study.

PURPOSE: Currently, the choice of a vascular prosthesis for a femoral-popliteal above-knee arterial bypass graft is left to the surgeon's preference, because the available information on comparative evaluations is inconclusive. The Department of Veterans Affairs (VA) Cooperative Study 141 was established to identify whether improved patency exists with different bypass graft materials for patients with femoral-popliteal above-knee bypass grafts.
METHODS: Between June 1983 and June 1988, 752 patients at 20 VA medical centers were randomized to receive either an externally supported polytetrafluoroethylene (PTFE; N = 265), human umbilical vein (HUV; N = 261), or saphenous vein (SV; N = 226) for an above-knee femoral-popliteal bypass graft. The indication for the bypass grafting operation was limb salvage in 67.5% of the patients. Patients were observed every 3 months for the first year and every 6 months thereafter. All patients were instructed to take aspirin (650 mg) daily for the duration of the study.Doppler-derived ankle-brachial indices (ABIs) were determined preoperatively and serially postoperatively. A bypass graft was considered to be patent when the Doppler-derived postoperative ABI remained significantly improved (more than 0.15 units higher than their preoperative value) and additional objective information, such as angiograms or operations, did not contradict these observations. Patency failure also included bypass grafts that were removed because of an infection or aneurysmal degeneration. Patency rates were compared by using the Kaplan-Meier life table analysis.
RESULTS: The cumulative assisted primary patency rates were statistically similar among the different conduit types at 2 years (SV, 81%; HUV, 70%; PTFE, 69%). After 5 years, above-knee SV bypass grafts had a significantly (P </=.01) better patency rate (73%) than HUV bypass grafts (53%), which had a significantly (P </=.01) better patency rate than PTFE bypass grafts (39%). Limb salvage was slightly worse with PTFE conduits. The number of bypass graft thromboses and major amputations within the first 30 days was highest in the HUV group.
CONCLUSION: The overall results of this prospective randomized study suggest that the SV should be considered as the bypass graft of choice for femoral-popliteal above-knee reconstruction and that, when a prosthetic bypass graft is used, an HUV should also be considered as an alternative choice to PTFE.

RCT Entities:   Population Interventions Outcomes