C Devine1, B Hons, C McCollum. 1. South Manchester University Hospital, Department of Surgery, United Kingdom.
Abstract
BACKGROUND:Dacron (polyester fiber) was largely abandoned for femoropopliteal bypass grafts 30 years ago because saphenous vein achieved better patencies. However, in patients taking aspirin, patency in above-knee femoropopliteal bypass grafts has recently been shown to be equivalent to that with saphenous vein. We compared heparin-bonded Dacron (HBD) and polytetrafluoroethylene (PTFE) in a randomized multicenter trial including below-knee popliteal or tibioperoneal trunk bypass graft where the long saphenous vein was absent or inadequate. METHODS: Over 28 months, 209 patients undergoing femoropopliteal bypass grafts (180 above-knee, 29 below-knee) were randomized to HBD (n = 106) or PTFE (n = 103). Each patient was given aspirin (300 mg/d) before surgery, and this continued unless the patient had intolerance to the aspirin. RESULTS: The mean follow-up was 42 months (range, 28-55). Fifteen (7.1%) patients died with patent grafts, and three (1.4%) infected grafts were removed. Patency (measured with Kaplan-Meier survival analysis) at 1, 2, and 3 years for HBD was 70%, 63%, and 55% compared with 56%, 46%, and 42%, respectively, for PTFE (P =.044). A total of 67 secondary interventions were performed on 48 thrombosed grafts; long-term patency was achieved in only three. Risk factors for arterial disease did not significantly influence patency. Amputations have been performed in 23 patients, six after HBD and 17 after PTFE bypass grafts (P =.015). CONCLUSIONS:HBD achieved better patency than PTFE, which carried a high risk of subsequent amputation.
RCT Entities:
BACKGROUND:Dacron (polyester fiber) was largely abandoned for femoropopliteal bypass grafts 30 years ago because saphenous vein achieved better patencies. However, in patients taking aspirin, patency in above-knee femoropopliteal bypass grafts has recently been shown to be equivalent to that with saphenous vein. We compared heparin-bonded Dacron (HBD) and polytetrafluoroethylene (PTFE) in a randomized multicenter trial including below-knee popliteal or tibioperoneal trunk bypass graft where the long saphenous vein was absent or inadequate. METHODS: Over 28 months, 209 patients undergoing femoropopliteal bypass grafts (180 above-knee, 29 below-knee) were randomized to HBD (n = 106) or PTFE (n = 103). Each patient was given aspirin (300 mg/d) before surgery, and this continued unless the patient had intolerance to the aspirin. RESULTS: The mean follow-up was 42 months (range, 28-55). Fifteen (7.1%) patients died with patent grafts, and three (1.4%) infected grafts were removed. Patency (measured with Kaplan-Meier survival analysis) at 1, 2, and 3 years for HBD was 70%, 63%, and 55% compared with 56%, 46%, and 42%, respectively, for PTFE (P =.044). A total of 67 secondary interventions were performed on 48 thrombosed grafts; long-term patency was achieved in only three. Risk factors for arterial disease did not significantly influence patency. Amputations have been performed in 23 patients, six after HBD and 17 after PTFE bypass grafts (P =.015). CONCLUSIONS:HBD achieved better patency than PTFE, which carried a high risk of subsequent amputation.
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