Prospective randomized study on bilateral above-knee femoropopliteal revascularization: polytetrafluoroethylene versus reversed saphenous vein.

ABSTRACT. Objective: Some controversy exists as to whether polytetrafluoroethylene (PTFE) is equivalent to reversed saphenous vein (SV) as bypass graft material for the above-knee (AK) femoropopliteal revascularization. The purpose of this study was to compare the 5-year patency rate of reversed SV and PTFE grafts in claudicant patients who underwent bilateral AK femoropopliteal revascularizations. Methods: Between January 1994 and December 1997, 51 patients (102 limbs) with bilateral disabling claudication due to superficial femoral artery occlusion were treated with SV AK femoropopliteal bypass on one limb and with PTFE AK femoropopliteal bypass on the other. They were randomly selected for sequential surgical treatment involving either SV/PTFE or PTFE/SV. Kaplan-Meier analysis was used to estimate the patency rates and various factors were analyzed to ascertain any association with revascularization failure. Results: There was no perioperative (30-day) limb loss or perioperative death. There were 5 late deaths (late survival rate: 90%). The mean follow-up was 59 months. In the SV group, 3 bypasses failed, requiring a reoperation in only one patient; in the PTFE group 8 bypasses failed leading to 5 reoperations. There was no statistically significant difference in primary “assisted” patency rate for the two grafts: 100%, 98% and 94% for SV bypasses and 96%, 84% and 84% for PTFE grafts (p = .09), after 1, 3 and 5 years, respectively. Conclusions: The overall results of this randomized study show that SV and PTFE grafts have statistically comparable patency rates when used in the AK location in claudicant patients. The use of SV does lead to fewer occlusions and reoperations, however.