PTFE or HUV for femoro-popliteal bypass: A multi-centre trial*

Despite wide clinical experience the choice between human umbilical vein (HUV) or polytetrafluoroethylene (PTFE) when the saphenous vein is inadequate remains unclear. In a multi-centre trial of 801 femoro-popliteal bypasses, autogenous vein could not be used in 252 (31 %), of which 191 were randomised to either HUV or PTFE and started on aspirin 300 mg plus dipyridamole 150mg (ASA + DPM) twice daily. Graft patency measured objectively by independent trial co-ordinators was expressed on an "intention to treat" basis by life table and analysed statistically by log rank and confidence intervals (95% CI). Overall, 101 grafts failed and cumulative patency was 53% (45–61 %) at 3 years compared with 60% (55–65%) in 549 vein grafts. Prosthetic bypass patency above knee was 65% (55–75%); markedly better than 35% (23–47%) below knee ( p Randomisation produced comparable groups of 87 HUV and 104 PTFE grafts. Cumulative primary patency for HUV was 68, 63 and 57% at 1, 2 and 3 years, respectively compared with 61, 56 and 48% for PTFE with wide confidence intervals for the difference at 3 years (−20 to 38%, p = 0.27). However, 19 grafts underwent thrombectomy, which improved secondary patency over 3 years to 66 %for HUV compared with 49% for PTFE ( p p = 0.077). In patients on platelet inhibitory drugs undergoing femoro-popliteal bypass, prosthetic grafts achieve similar patency to autologous vein above the knee. The main study endpoint of primary patency was not significantly different between HUV and PTFE.