A randomized clinical trial of PTFE versus human umbilical vein for femoropopliteal bypass surgery. Preliminary results.

PTFE (Goretex) and modified human umbilical vein (Biograft) vascular grafts were compared in femorodistal popliteal artery bypass surgery in a randomized clinical multicentre trial. During 18 months 104 patients (104 limbs) entered the trial. Twenty-five patients suffered from claudication, 54 suffered rest pain and 25 patients had ulceration or gangrene. The median preoperative ankle-arm blood pressure index was 0 . 34. Twenty-three limbs had 3 patent tibial arteries, 45 limbs had 2 tibial arteries, 31 limbs had 1 tibial artery while 5 limbs had an isolated popliteal segment. Thirty-six of the operations were redo-operations. Fifty-four patients were allocated to PTFE and 50 to umbilical vein. During follow-up (maximum 650 days) 24 PTFE grafts occluded against 12 umbilical veins. The 1-year patency rate was 40 per cent in the PTFE group against 75 per cent in the umbilical vein group (P = 0 . 014, Gehans test). During the first year the PTFE failure rate was on average 3 . 1 times higher than that of the umbilical vein.

RCT Entities:   Population Interventions Outcomes