Abstract 9011: Randomized Trial of Fondaparinux versus Heparin to Prevent Graft Failure After Coronary Artery Bypass Grafting: The Fonda CABG Pilot Study
Background: Thrombosis the major mechanism of early graft failure after CABG. Fondaparinux is effective for the prevention of death, MI, and stroke in patients with ACS but has not been studied for the prevention of graft failure and CV events post CABG. We performed a pilot RCT to assess the feasibility of comparing the efficacy and safety of fondaparinux versus heparin for prevention of graft failure and CV events in CABG patients.
Methods: Patients undergoing CABG were randomized to receive post operative injections of fondaparinux 2.5 mg o.d. or heparin 5000 IU b.i.d. while in-hospital. After hospital discharge, the fondaparinux group continued to receive fondaparinux 2.5 mg o.d. and the heparin group received placebo injections o.d. until day 28 post-surgery. Efficacy outcomes were graft failure (diagnosed by cardiac CT angiography), death, MI, and stroke at 30 days. Safety outcomes were bleeding, transfusion, and reoperation for bleeding.
Results: 100 patients were recruited, 99 were randomized (1 died prior to randomization), 49 received fondaparinux and 50 received in-hospital heparin. CT angiography was performed in 97% of patients. 188 grafts were imaged in the treatment group and 189 grafts in the heparin group, including a total of 238 saphenous vein grafts and 138 arterial grafts. A similar proportion of patients treated with fondaparinux compared with heparin had at least one occluded graft (18.8% fondaparinux vs. 14.9% heparin, p=0.62) and a similar number of grafts were occluded in each treatment group (total 4.8% vs. 4.8%, p=0.99). There was no difference between treatment groups in death, MI, stroke, bleeding events, or reoperation.
Conclusions: One in 10 patients undergoing CABG have at least 1 occluded graft at 30 days and one in 20 grafts are blocked. Our study suggests that fondaparinux is a safe alternative to heparin after CABG and that it is feasible to conduct a definitive RCT using CT angiography to evaluate the effect of treatment on graft patency.
- © 2010 by American Heart Association, Inc.