Efficacy and Safety of Fondaparinux Versus Enoxaparin in Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary InterventionResults From the OASIS-5 Trial
Shamir R. Mehta, MD, MSc, FACC*,1,2,*,
Christopher B. Granger, MD, FACC ,1,
John W. Eikelboom, MD, MSc*,1,
Jean-Pierre Bassand, MD, FACC ,1,
Lars Wallentin, MD, PhD ,3,
David P. Faxon, MD, FACC||,1,
Ron J.G. Peters, MD¶,1,
Andrzej Budaj, MD**,1,
Rizwan Afzal, MSc*,
Susan Chrolavicius, BSc*,
Keith A.A. Fox, MBChB, FRCP,1 and
Salim Yusuf, DPhil, FRCPC, FACC*,1
* Department of Medicine, McMaster University and Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada
Duke Clinical Research Institute, Duke University, Durham, North Carolina
Centre Hospitalier Universitaire Jean Minjoz, Besançon, France
Department of Medical Sciences and Uppsala Clinical Research Centre, University Hospital, Uppsala, Sweden
|| Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
¶ Academic Medical Centre, Amsterdam, the Netherlands
** Postgraduate Medical School, Department of Cardiology, Grochowski Hospital, Warsaw, Poland
Royal Infirmary and University of Edinburgh, Edinburgh, Scotland.
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Figure 1 Dosing of Study Drug in Patients Undergoing PCI
The dosing regimen for percutaneous coronary intervention (PCI) procedures in the fondaparinux (fonda) and enoxaparin (enox) groups according to time after last subcutaneous (sc) dose of study drug and use of glycoprotein (GP) IIb/IIIa antagonists. All study drugs were given in a double-blind, double-dummy fashion. IV = intravenous; UFH = unfractionated heparin.
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Figure 2 Flow Diagram of Patients Undergoing PCI
The disposition of patients undergoing percutaneous coronary intervention (PCI) in the OASIS-5 trial in relation to randomized treatment and use of open-label unfractionated heparin (UFH). *8 days was the maximum duration of study drug administration. Mean duration of treatment was 2.5 days. Following protocol amendment.
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Figure 3 Major Bleeding and Angiographic Complications
Major bleeding 48 h after PCI and angiographic complications, according to use of protocol-specified UFH in the enoxaparin group. If PCI was performed within 6 h of the last subcutaneous enoxaparin dose, no additional UFH was given. If PCI was performed after 6 h from the last subcutaneous enoxaparin dose, supplemental UFH was administered for the PCI. Major bleeding was reduced with fondaparinux irrespective of whether UFH was used in the enoxaparin group. Angiographic complications were reduced when UFH was used for the PCI procedure compared with either fondaparinux alone or with enoxaparin alone. CI = confidence interval; RR = relative risk; other abbreviations as in Figure 1.
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Figure 4 Major Bleeding With Concurrent Use of GP IIb/IIIa Antagonists and Pretreatment With Clopidogrel
Major bleeding in relation to concurrent use of glycoprotein (GP) IIb/IIIa antagonists and clopidogrel pretreatment at least 6 h before percutaneous coronary intervention (PCI). Major bleeding was significantly reduced with fondaparinux (yellow) compared with enoxaparin (red) with or without concurrent use of these antiplatelet agents. GP IIb/IIIa (+) = GP IIb/IIIa inhibitor used before/during PCI; GP IIb/IIIa (–) = GP IIb/IIIa inhibitor not used before/during PCI; clopidogrel (+) = clopidogrel given at least 6 h before PCI; clopidogrel (–) = clopidogrel not given at least 6 h before PCI. CI = confidence interval; HR = hazard ratio.
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