Six-year prospective multicenter randomized comparison of autologous saphenous vein and expanded polytetrafluoroethylene grafts in infrainguinal arterial reconstructions.

Autologous saphenous vein (ASV) and polytetrafluoroethylene (PTFE) grafts were compared in 845 infrainguinal bypass operations, 485 to the popliteal artery and 360 to infrapopliteal arteries. Life-table primary patency rates for randomized PTFE grafts to the popliteal artery paralleled those for randomized ASV grafts to the same level for 2 years and then became significantly different (4-year patency rate of 68% +/- 8% [SE] for ASV vs. 47% +/- 9% for PTFE, p less than 0.025). Four-year patency differences for randomized above-knee grafts were not statistically significant (61% +/- 12% for ASV vs. 38% +/- 13% for PTFE, p greater than 0.25) but were for randomized below-knee grafts (76% +/- 9% for ASV vs. 54% +/- 11% for PTFE, p less than 0.05). Four-year limb salvage rates after bypasses to the popliteal artery to control critical ischemia did not differ for the two types of randomized grafts (75% +/- 10% for ASV vs. 70% +/- 10% for PTFE, p greater than 0.25). Although primary patency rates for randomized and obligatory PTFE grafts to the popliteal artery were significantly different (p less than 0.025), 4-year limb salvage rates were not (70% +/- 10% vs. 68% +/- 20%, p greater than 0.25). Primary patency rates at 4 years for infrapopliteal bypasses with randomized ASV were significantly better than those with randomized PTFE (49% +/- 10% vs. 12% +/- 7%, p less than 0.001). Limb salvage rates at 3 1/2 years for infrapopliteal bypasses with both randomized grafts (57% +/- 10% for ASV and 61% +/- 10% for PTFE) were better than those for obligatory infrapopliteal PTFE grafts (38% +/- 11%, p less than 0.01). These results fail to support the routine preferential use of PTFE grafts for either femoropopliteal or more distal bypasses. However, this graft may be used preferentially in selected poor-risk patients for femoropopliteal bypasses, particularly those that do not cross the knee. Although every effort should be made to use ASV for infrapopliteal bypasses, a PTFE distal bypass is a better option than a primary major amputation.

RCT Entities:   Population Interventions Outcomes