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European Heart Journal Advance Access originally published online on December 15, 2007
European Heart Journal 2008 29(3):315-323; doi:10.1093/eurheartj/ehm578
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Effects of fondaparinux in patients with ST-segment elevation acute myocardial infarction not receiving reperfusion treatment

Jonas Oldgren1,*, Lars Wallentin1, Rizwan Afzal2, Jean-Pierre Bassand3, Andrzej Budaj4, Susan Chrolavicius2, Keith A.A. Fox5, Christopher B. Granger6, Shamir R. Mehta2, Prem Pais7, Ron J.G. Peters8, Denis Xavier2,7, Jun Zhu9, Salim Yusuf for the OASIS-6 Investigators2

1 Uppsala Clinical Research Center, Uppsala University Hospital, S-751 85 Uppsala, Sweden
2 Department of Medicine, Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada
3 Division of Cardiology, University of Besancon, Besancon, France
4 Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland
5 Cardiovascular Research Division, University of Edinburgh, Edinburgh, United Kingdom
6 Division of Cardiology, Duke University, Durham, NC, USA
7 Division of Clinical Trials, St. John’s Medical College, Bangalore, India
8 Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands
9 Emergency Division, Fuwai Hospital, CAMS and PUMC, The People’s Republic of China

Received 21 May 2007; revised 31 October 2007; accepted 15 November 2007; online publish-ahead-of-print 15 December 2007.

* Corresponding author: Tel: +46 18 611 9502, Fax: +46 18 506638, Email: jonas.oldgren{at}ucr.uu.se

Aims: At least one quarter of ST-segment elevation myocardial infarction (STEMI) patients do not receive reperfusion therapy, and these patients are at high risk for new ischaemic events. We evaluated fondaparinux treatment vs. usual care, i.e. placebo or unfractionated (UF) heparin, in a pre-specified subgroup of 2867 (out of 12 092) patients not receiving reperfusion treatment in the OASIS-6 trial.

Methods: In all, 1458 patients were randomized to fondaparinux 2.5 mg once daily subcutaneously up to 8 days and 1409 patients to usual care (control). Randomization was stratified by indication for UF heparin (stratum II, n = 1226) or not (stratum I, n = 1641) based on the investigator’s judgment.

Results: The proportion of patients who suffered death or myocardial re-infarction at 30 days (primary outcome) was 12.2% in the fondaparinux vs. 15.1% in the control group, hazard ratio (HR) 0.80; 95% confidence interval (CI) 0.65–0.98. There was no increase in severe bleedings, HR 0.82; CI 0.44–1.55, or strokes, HR 0.62; CI 0.29–1.33. Consequently, the composite of death, myocardial re-infarction, or severe bleeding were significantly reduced at 30 days, HR 0.81; CI 0.67–0.99. Reductions in death or myocardial re-infarction at 30 days were consistent in stratum I with fondaparinux vs. placebo, HR 0.88; 95% CI 0.65–1.19, and in stratum II with fondaparinux vs. UF heparin infusion for 24–48 h (n = 806), HR 0.74; CI 95% 0.57–0.97, P = 0.41 for heterogeneity.

Conclusion: In STEMI patients not receiving reperfusion treatment, fondaparinux reduces the composite of death or myocardial re-infarction without an increase in severe bleedings or strokes as compared to placebo or UF heparin.

Key Words: Acute myocardial infarction • Anticoagulants


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