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OASIS-5 TRIAL |
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|---|---|
| Problem | ACS (UA/NSTEMI) |
| Format | Double-blinded multi-center RCT |
| Treatment | Fondaparinux 2.5mg daily |
| Control | Enoxaparin 1mg/kg |
| Population | 20,078 patients |
| Inclusion criteria | Patients were randomly assigned to a study group within 24 hours after the onset of symptoms and were eligible if they met at least two of the three following criteria: an age of at least 60 years, an elevated level of troponin or creatine kinase MB isoenzyme, or electrocardiographic changes indicative of ischemia. |
| Exclusion criteria | Contraindications to low-molecular-weight heparin Recent hemorrhagic stroke Indications for anticoagulation other than an acute coronary syndrome Serum creatinine level of at least 3 mg per deciliter (265 Î_mol per liter) |
| Follow-up | Minimum 90d, max 180d |
| Primary endpoint | Death, myocardial infarction, or refractory ischemia Primary safety objective was to determine whether fondaparinux was superior to enoxaparin in preventing major bleeding. |
| Secondary endpoint(s) | Death or myocardial infarction Death, myocardial infarction, or refractory ischemia The individual components of these composite outcomes ...At 30 days and at the end of the study |
| Details | . |
| Brief summary: | Fondaparinux in UA/NSTEMI less bleeding than enoxaparin hence improved mortality |
| PAPER: Comparison of Fondaparinux and Enoxaparin in Acute Coronary Syndromes | |
|---|---|
| Date | 6 Apr 2006 |
| Journal | N Engl J Med. 2006 Apr 6;354(14):1464-76. |
| Information | Fondaparinux 2.5mg vs Enoxaparin 1mg/kg -Similar risks of ischaemic events @ 9days -Significant reduction (50%) in major bleeding -Significant improvement in long-term mortality (17%) & morbidity |
| PAPER: Efficacy and Safety of Fondaparinux Versus Enoxaparin in Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention | |
|---|---|
| Date | 30 Oct 2007 |
| Journal | J Am Coll Cardiol. 2007 Oct 30;50(18):1742-51. |
| Information | Subgroup analysis on patients undergoing PCI Fondparinux 2.5mg vs Enoxaparin 1mg/kg -Reduced risks of major bleeding -Catheter thrombus more common in patients receiving fondaparinux --Largely prevented by using unfractionated heparin @ PCI (no increase in bleeding) |