Key result
LMWH improves 12-month graft patency by ~14 percentage points vs aspirin-dipyridamole, driven by salvage surgery.
Why the study?
Low-molecular weight heparin may have advantages over aspirin and dipyridamole in maintaining vascular graft patency after femoropopliteal bypass grafting due to better antithrombotic and antiproliferative effects.
Does low-molecular weight heparin improve graft patency in patients undergoing femoropopliteal bypass grafting compared to aspirin and dipyridamole?
RCT (n=200)
Does low-molecular weight heparin improve graft patency in patients undergoing femoropopliteal bypass grafting compared to aspirin and dipyridamole?
Low-molecular weight heparin is superior to aspirin and dipyridamole for maintaining femoropopliteal-graft patency in patients undergoing salvage surgery for critical limb ischemia, without an increase in major bleeding.
Supports low-molecular-weight heparin over aspirin-dipyridamole for 12-month patency after salvage femoropopliteal bypass; extends RCT evidence in critical limb ischemia.
Low-molecular weight heparin has theoretical advantages over aspirin and dipyridamole in maintaining vascular-graft patency by virtue of its better antithrombotic effect and antiproliferative activity on vascular, smooth-muscle cells. We tested the hypothesis that low-molecular weight heparin would be more effective than aspirin and dipyridamole in maintaining graft patency in patients undergoing femoropopliteal bypass grafting. Patients were randomised to receive either a daily injection of 2500 IU low-molecular weight heparin, or 300 mg aspirin with 100 mg dipyridamole 8 hourly for 3 months. 94 patients were randomised to low-molecular weight heparin and 106 to aspirin and dipyridamole. Patients were stratified according to indication for surgery and were followed up for 1 year. Kaplan-Meier estimate of graft patency showed 87% graft survival on low-molecular-weight heparin and 72% on aspirin and dipyridamole at 6 months. At 12 months, the respective figures were 78% and 64%. Stratified survival analysis showed that this benefit was confined to those having salvage surgery (log rank test p = 0.0006); for those having surgery for claudication there was no significant benefit. No major bleeding events occurred in either group. We conclude that low-molecular weight heparin is better than aspirin and dipyridamole in maintaining femoropopliteal-graft patency in patients with critical limb ischaemia undergoing salvage surgery. This treatment should have considerable cost benefits.
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Edmondson et al. (1994) conducted an RCT in Femoropopliteal bypass grafting (n=200). Low-molecular weight heparin vs. 300 mg aspirin with 100 mg dipyridamole 8 hourly was evaluated on Graft patency at 12 months (p=0.0006 for salvage surgery subgroup). Low-molecular weight heparin improved 12-month graft patency compared to aspirin and dipyridamole (78% vs 64%), with the benefit confined to patients undergoing salvage surgery (P=0.0006).
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