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Randomized trial of fondaparinux versus heparin to prevent graft failure after coronary artery bypass grafting: the Fonda CABG study

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Abstract

We sought to assess the feasibility of comparing the efficacy and safety of fondaparinux versus heparin for prevention of graft failure and major CV events in patients undergoing coronary artery bypass grafting (CABG). Patients undergoing CABG were randomized to receive postoperative injections of fondaparinux or heparin in-hospital. After discharge, the fondaparinux group received fondaparinux and the heparin group received placebo injections for 30 days post surgery. Efficacy outcomes were graft failure, death, MI, and stroke at 30 days. Safety outcomes were bleeding, transfusion, and reoperation. 100 patients were recruited, 99 were randomized, 49 received fondaparinux and 50 received heparin. CT angiography was performed in 97% of patients. 188 grafts in the treatment group and 189 grafts in the heparin group were imaged. 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 (all grafts: 4.8% vs. 4.8%, P = 0.99; saphenous vein grafts 4.2% vs. 4.2%, P = 0.98). There was no difference between treatment groups in death, MI, stroke, bleeding events, or reoperation. One in 10 patients undergoing CABG had at least one occluded graft at 30 days and one in 20 grafts is occluded by 30 days. Fondaparinux appears to be a safe alternative to heparin after CABG and it is feasible to conduct a definitive RCT using CT angiography to evaluate the effect of fondaparinux treatment on graft patency.

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Acknowledgments

We would like to thank Toni Rizzo for recruiting the patients and coordinating the study as well as colleagues in the McMaster University Division of Cardiac Surgery for their support. This research was supported by a research grant from Glaxo-Smith-Kline Canada who also provided fondaparinux and placebo for the study. Dr Sun has also received a research grant from Bristol-Myers-Squibb Canada. Drs Yusuf, Eikelboom, and Warkentin have received grants and honoraria from Glaxo-Smith-Kline who own and market fondaparinux.

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Authors and Affiliations

  1. Division of Cardiac Surgery, Brigham & Women’s Hospital, Harvard Medical School, Boston, MA, 02115, USA

    Jack C. J. Sun

  2. Division of Cardiac Surgery, McMaster University, Hamilton, Canada

    Kevin H. T. Teoh & Andre Lamy

  3. Division of Cardiology, McMaster University, Hamilton, Canada

    Tej Sheth & Salim Yusuf

  4. Department of Radiology, McMaster University, Hamilton, Canada

    David Landry

  5. Population Health Research Institute, McMaster University, Hamilton, Canada

    Hyejung Jung, Salim Yusuf, Andre Lamy & John W. Eikelboom

  6. Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Canada

    Theodore E. Warkentin

  7. Department of Medicine, McMaster University, Hamilton, Canada

    Theodore E. Warkentin, Salim Yusuf & John W. Eikelboom

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  1. Jack C. J. Sun
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  2. Kevin H. T. Teoh
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  9. John W. Eikelboom
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Correspondence to Jack C. J. Sun.

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Clinical trial registration information

clinicaltrials.gov identifier NCT00474591.

http://clinicaltrials.gov/ct2/show/NCT00474591

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Sun, J.C.J., Teoh, K.H.T., Sheth, T. et al. Randomized trial of fondaparinux versus heparin to prevent graft failure after coronary artery bypass grafting: the Fonda CABG study. J Thromb Thrombolysis 32, 378–385 (2011). https://doi.org/10.1007/s11239-011-0613-6

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  • DOI: https://doi.org/10.1007/s11239-011-0613-6

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