Human umbilical vein versus heparin-bonded polyester for femoro-popliteal bypass: 5-year results of a prospective randomized multicentre trial.

PURPOSE: To compare long-term patency of Heparin-Bonded Dacron (HBD) and Human Umbilical Vein (HUV) vascular prostheses in above-knee femoro-popliteal bypass surgery. DESIGN: A prospective randomized multi-centre clinical trial. PATIENTS AND METHODS: Femoro-popliteal bypasses were performed in 129 patients between 1996 and 2001. After randomization 70 patients received an HUV and 59 an HBD prosthesis. Patients were followed up every three months during the first postoperative year and yearly thereafter. The median follow-up was 60 months (range 3-96 months). Graft occlusions were detected by duplex scanning, angiography or surgical exploration. RESULTS: The cumulative primary patency rates were 79%, 66% and 58% at 1, 3 and 5 years postoperatively. Primary patency rates for HUV were 74%, 64% and 58% at 1, 3 and 5 years and 84%, 68% and 58% for HBD, respectively (log-rank test, p=0.745). Overall secondary patency rates were 82%, 72% and 61% at 1, 3 and 5 years postoperatively. The overall cumulative limb salvage at 5 years follow-up was 89% (CI 80%-91%) and was not dependent on graft type. Smoking (p=0.019), number of patent crural arteries (p=0.030) and previous cerebro-vascular events (p=0.030) were significant predictors of graft occlusion. CONCLUSION: There was no difference in long-term graft performance between HUV and HBD for above knee infrainguinal bypass.