Randomized trial comparing infrainguinal polytetrafluoroethylene bypass grafting with and without vein interposition cuff at the distal anastomosis. The Joint Vascular Research Group.

PURPOSE: A multicenter randomized prospective study was undertaken to determine whether an interposition vein cuff improved the short-term and medium-term patency and limb salvage rates of femoral-above-knee and femoral-below-knee popliteal artery polytetrafluoroethylene (PTFE) bypass procedures.

METHODS: Two hundred sixty-one bypass operations were randomized (133 to vein cuff and 128 to no vein cuff). One hundred fifty grafts were to the above-knee popliteal artery, 96 to the below-knee popliteal artery, and 15 to tibial vessels. The median follow-up was 617 days.

RESULTS: The 12-month patency rates for cuffed and uncuffed above-knee popliteal artery PTFE bypass grafts were 80% and 84%, and the 2-year patency rates were 72% and 70%, respectively. The patency rates for bypass grafts to the below-knee popliteal artery at 12 months were 80% and 65% and at 2 years 52% and 29%, respectively (p = 0.03). At the below-knee site, this was reflected in 24-month difference in limb salvage rates of 84% and 62%, respectively (p = 0.08).

CONCLUSIONS: There was no improvement in the patency rate with the use of a distal anastomosis interposition vein cuff in femoral-above-knee popliteal PTFE bypass grafts, but there was a statistically significant advantage when PTFE bypass grafts were anastomosed to the popliteal artery below the knee.