Prospective randomised trial of distal arteriovenous fistula as an adjunct to femoro-infrapopliteal PTFE bypass

Abstract

Objectives: to compare graft patency and limb salvage rate following femoro-infrapopliteal bypass using ePTFE grafts with and without the addition of adjuvant arterio-venous fistula. Design: a prospectively randomised controlled trial. Materials: patients referred to two teaching hospital vascular surgery units in the U.K. for the treatment of critical limb ischaemia. Methods: eighty-seven patients (M:F; 2.3:1) undergoing 89 femoro-intrapopliteal bypass operations with ePTFE grafts for critical limb ischaemia were randomly allocated to have AVF included in the operative procedure (n = 48) or to a control group without AVF (n = 41). An interposition vein-cuff was incorporated at the distal anastomosis in all patients. Results: the cumulative rates of primary patency and limb salvage at 1-year after operation for patients with AVF were 55.2% and 54.1% compared to 53.4% and 43.2%, respectively, for the control group. The differences between the AVF and control groups did not reach statistical significance, in terms of either graft patency or limb salvage, at any stage after the operation (Log-Rank test). Conclusions: AVF confers no additional significant clinical advantage over interposition vein cuff in patients having femoro-intrapopliteal bypass with ePTFE grants for critical limb ischaemia.