Background The combined use of anticoagulants, antiplateletagents, and invasive coronary procedures reduces ischemic coronaryevents but also increases bleeding in patients with acute coronarysyndromes. We therefore assessed whether fondaparinux wouldpreserve the anti-ischemic benefits of enoxaparin while reducingbleeding.
Methods We randomly assigned 20,078 patients with acute coronarysyndromes to receive either fondaparinux (2.5 mg daily) or enoxaparin(1 mg per kilogram of body weight twice daily) for a mean ofsix days and evaluated death, myocardial infarction, or refractoryischemia at nine days (the primary outcome); major bleeding;and their combination. Patients were followed for up to sixmonths.
Results The number of patients with primary-outcome events wassimilar in the two groups (579 with fondaparinux [5.8 percent]vs. 573 with enoxaparin [5.7 percent]; hazard ratio in the fondaparinuxgroup, 1.01; 95 percent confidence interval, 0.90 to 1.13),satisfying the noninferiority criteria. The number of eventsmeeting this combined outcome showed a nonsignificant trendtoward a lower value in the fondaparinux group at 30 days (805vs. 864, P=0.13) and at the end of the study (1222 vs. 1308,P=0.06). The rate of major bleeding at nine days was markedlylower with fondaparinux than with enoxaparin (217 events [2.2percent] vs. 412 events [4.1 percent]; hazard ratio, 0.52; P<0.001).The composite of the primary outcome and major bleeding at ninedays favored fondaparinux (737 events [7.3 percent] vs. 905events [9.0 percent]; hazard ratio, 0.81; P<0.001). Fondaparinuxwas associated with a significantly reduced number of deathsat 30 days (295 vs. 352, P=0.02) and at 180 days (574 vs. 638,P=0.05).
Conclusions Fondaparinux is similar to enoxaparin in reducingthe risk of ischemic events at nine days, but it substantiallyreduces major bleeding and improves long term mortality andmorbidity. (ClinicalTrials.gov number, NCT00139815
[ClinicalTrials.gov]
.)
Source Information
The Writing Committee (Salim Yusuf, D.Phil., M.B., B.S., Shamir R. Mehta, M.D., Susan Chrolavicius, B.A., Rizwan Afzal, M.Sc., Janice Pogue, M.Sc., Christopher B. Granger, M.D., Andrzej Budaj, Ph.D., Ron J.G. Peters, M.D., Jean-Pierre Bassand, M.D., Lars Wallentin, Ph.D., Campbell Joyner, M.D., and Keith A.A. Fox, F.R.C.P.) assumes responsibility for the overall content and integrity of the article. This article was published at www.nejm.org on March 14, 2006.
Address reprint requests to Dr. Yusuf at the Population Health Research Institute, McMaster Clinic, Hamilton General Hospital, 237 Barton St. East, Hamilton, ON L8L 2X2, Canada.
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