Prosthetic above-knee femoropopliteal bypass grafting: Five-year results of a randomized trial

Purpose: This trial was designed to identify factors affecting patency rate s of primary prosthetic above-knee femoropopliteal bypass grafts at 5 years . Methods: A multi-institutional, prospective trial randomized 240 patients t o compare patency rates of Gore-tex and Hemashield above-knee femoropoplite al bypass grafts at 5 years. Univariate comparisons of patency between leve ls of each prognostic variable were made with the Kaplan-Meier method. Vari ables that had a univariate P value less than .25 or those known to be impo rtant were submitted to a Cox regression analysis. Results: The patient survival rate at 5 years was 59.4%. There were no diff erences in primary or secondary patency rates at 5 years between the two gr aft materials (primary, 45% vs 43% and secondary, 68% vs 68%). The risk for graft occlusion was significantly increased for patients younger than 65 y ears (2.1; P = .001) and for grafts with a diameter less than 7 mm (1.65; P = .0219). Variables with no apparent independent effect on patency rates w ere smoking status, runoff, diabetes mellitus, sex, presenting symptoms, an d postoperative treatment with aspirin or Coumadin. Noninvasive test result s were not predictive of subsequent graft function. Conclusion: Although the type of prosthetic used for above-knee femoropopli teal bypass grafts does not affect 5-year patency rates, age and graft size do influence results. These factors should be considered before a prosthet ic bypass grafting procedure. Furthermore, these data should serve as a con temporary standard, with which evolving and conventional procedures can be compared.