Randomization of autogenous vein and polytetrafluorethylene grafts in femoral-distal reconstruction.

A randomized, prospective, controlled study comparing autogenous saphenous vein and polytetrafluoroethylene (PTFE) grafts in infrainguinal arterial reconstructions has been initiated in three different institutions. A total of 446 operative procedures were divided into six groups, depending on the site of distal bypass insertion into the popliteal or an infrapopliteal artery and on whether the patient received a randomized vein or PTFE graft or an obligatory PTFE graft. The randomized saphenous vein graft patency to infrapopliteal arteries was significantly better (P less than 0.005) at 2 1/2 years than the patency of randomized or obligatory PTFE grafts to the same level. No significant differences between randomized vein grafts and randomized or obligatory PTFE grafts in the femoropopliteal position could be demonstrated up to 2 1/2 years, either above or below the knee. The need for such a study and the limitations of this preliminary report are discussed. The requirement for longer observation of greater numbers of cases is stressed. A current plan for usage of the PTFE graft in the lower extremity is presented.

RCT Entities:   Population Interventions Outcomes