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 150 mg (ASA + DPM) twice daily. Graft patency measured objectively by independent trial coordinators 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 less than 0.001) and comparable with 62% (55-69%) in 217 above knee saphenous vein grafts. Most failures occurred early at a rate of 52/1000 patient-months in the first 3 months (43/1000 for vein) falling to 21/1000 by 6 to 12 months and around 10/1000 subsequently. 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).(ABSTRACT TRUNCATED AT 250 WORDS)
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