Randomized trial reveals higher one-year patency with human umbilical vein versus PTFE in femorodistal popliteal bypass surgery, suggesting superior durability for vein biografts.
Key Points
To compare the efficacy and patency rates of polytetrafluoroethylene (PTFE) against modified human umbilical vein grafts in femorodistal popliteal artery bypass surgery.
Multicenter randomized clinical trial enrolling 104 patients (104 limbs) allocated to receive either PTFE (n=54) or modified human umbilical vein (n=50) over an 18-month duration.
Patients presented with claudication (n=25), rest pain (n=54), or tissue necrosis/gangrene (n=25), with a maximum follow-up of 650 days.
The 1-year graft patency rate reached 75% in the umbilical vein group compared to 40% in the PTFE group (P = 0.014, Gehan's test).
Graft failure occurred in 24 of 54 PTFE recipients compared to 12 of 50 umbilical vein recipients, reflecting an average failure rate 3.1 times higher for PTFE during the first postoperative year.