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CLINICAL RESEARCH: ACUTE CORONARY SYNDROME

Efficacy and Safety of Fondaparinux Versus Enoxaparin in Patients With Acute Coronary Syndromes Treated With Glycoprotein IIb/IIIa Inhibitors or Thienopyridines

Results From the OASIS 5 (Fifth Organization to Assess Strategies in Ischemic Syndromes) Trial

Sanjit S. Jolly, MD, MSc^_*,_*, David P. Faxon, MD, Keith A.A. Fox, MB, ChB, Rizwan Afzal, MSc^_*, William E. Boden, MD, Petr Widimsky, MD^||, P. Gabriel Steg, MD^¶, Vicent Valentin, MD^#, Andrez Budaj, MD^_**, Christopher B. Granger, MD, Campbell D. Joyner, MD, Susan Chrolavicius, BScN^_*, Salim Yusuf, DPhil^_* and Shamir R. Mehta, MD, MSc^_*

^_* Department of Medicine, Hamilton Health Sciences, Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada
Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts
Royal Infirmary and University of Edinburgh, Edinburgh, Scotland
Department of Cardiology, University of Buffalo School of Medicine, Buffalo General Hospital, Buffalo, New York
^|| Charles University, Hospital Kralovske Vinohrady, Prague, Czech Republic
^¶ Département de Cardiologie, INSERM U-698, Université Paris 7, AP-HP, Paris, France
^# Hospital Universitari Dr. Peset, Valencia, Spain
^_** Postgraduate Medical School, Department of Cardiology, Grochowski Hospital, Warsaw, Poland
Duke Clinical Research Institute, Duke University, Durham, North Carolina
Department of Medicine, Sunnybrook Health Sciences Center, University of Toronto, Toronto, Ontario, Canada

Manuscript received January 6, 2009; revised manuscript received March 18, 2009, accepted March 24, 2009.

^_* Reprint requests and correspondence: Dr. Sanjit S. Jolly, McMaster Clinic Room 630, Hamilton General Hospital, 237 Barton Street East, Hamilton, Ontario L8L 2X2, Canada (Email: jollyss{at}mcmaster.ca).

Objectives: This study sought to evaluate the relative safety and efficacy of fondaparinux and enoxaparin in patients with acute coronary syndromes (ACS) treated with glycoprotein (GP) IIb/IIIa inhibitors or thienopyridines.

Background: The OASIS 5 (Fifth Organization to Assess Strategies in Ischemic Syndromes) trial showed that fondaparinux reduced major bleeding by 50% compared with enoxaparin while preserving similar efficacy. Whether this benefit is consistent in the presence or absence of concurrent antiplatelet therapy with clopidogrel and GP IIb/IIIa inhibitors is unknown.

Methods: Patients with ACS (n = 20,078) were randomized as a part of the OASIS 5 trial to receive either fondaparinux or enoxaparin. The use of GP IIb/IIIa inhibitors or thienopyridines was at the discretion of the treating physician. A Cox proportional hazard model was used to compare outcomes.

Results: Of the 20,078 patients randomized, 3,630 patients received GP IIb/IIIa and 13,531 received thienopyridines. There was a 40% reduction in major bleeding with fondaparinux compared with enoxaparin in those treated with GP IIb/IIIa (5.2% vs. 8.3%, hazard ratio [HR]: 0.61, p < 0.001). A similar reduction was found in those treated with thienopyridines (3.4% vs. 5.4%, HR: 0.62, p < 0.001). Ischemic events were similar between the groups, resulting in a superior net clinical outcome (death, myocardial infarction, refractory ischemia, or major bleeding) favoring fondaparinux (GP IIb/IIIa subgroup 14.8% vs. 18.9%, HR: 0.77, p = 0.001 and thienopyridines subgroup 11.0% vs. 13.2%, HR: 0.82, p < 0.001).

Conclusions: In patients receiving GP IIb/IIIa inhibitors or thienopyridines, fondaparinux reduces major bleeding and improves net clinical outcome compared with enoxaparin.

Key Words: anticoagulants • acute coronary syndromes • hemorrhage

Abbreviations and Acronyms   ACS = acute coronary syndrome   CI = confidence interval   CK-MB = creatine kinase-myocardial band   GP = glycoprotein   HR = hazard ratio   MI = myocardial infarction   NSTE = non–ST-segment elevation   OR = odds ratio   PCI = percutaneous coronary intervention   RR = relative risk

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J. Am. Coll. Cardiol. 2009 54: A26. [Full Text] [PDF]