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OASIS-5: Comparison of Fondaparinux and Enoxaparin in Acute Coronary Syndromes

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OASIS-5: Comparison of Fondaparinux and Enoxaparin in Acute Coronary Syndromes

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    1. OASIS-5: Comparison of Fondaparinux and Enoxaparin in Acute Coronary Syndromes Purpose To compare the efficacy and safety of fondaparinux and enoxaparin in high-risk patients with unstable angina or non-ST-segment elevation myocardial infarction Reference The Fifth Organization to Assess Strategies in Acute Ischemic Syndromes Investigators. Comparison of Fondaparinux and Enoxaparin in Acute Coronary Syndromes. N Engl J Med 2006;354:1464-76.

    2. OASIS-5: Comparison of Fondaparinux and Enoxaparin in Acute Coronary Syndromes - TRIAL DESIGN - Design Multicenter, multinational, randomized, double-blind, double-dummy Patients 20,078 patients, aged =60 years, with UA or MI without persistent ST elevation. Patients with hemorrhagic stroke within the last 12 months, previous revascularization and severe renal insufficiency excluded Follow up and primary endpoint Primary endpoint: death, myocardial infarction or refractory ischemia at 9 days. Follow up to 6 months. Treatment Fondaparinux 2.5 mg s.c. daily or enoxaparin 1 mg/kg s.c. twice daily, for a mean of 6 days

    3. OASIS-5: Comparison of Fondaparinux and Enoxaparin in Acute Coronary Syndromes - TRIAL DESIGN continued-

    4. OASIS-5: Comparison of Fondaparinux and Enoxaparin in Acute Coronary Syndromes - RESULTS - The primary efficacy outcome (death, MI, refractory ischemia at 9 days) occurred in 5.8% of patients receiving fondaparinux and 5.7% patients receiving enoxaparin (HR 1.01, 95% CI 0.90,1.03) Main secondary outcome (death or MI): 4.1% in both groups (HR 0.99, 95% CI 0.86,1.13) Significant reduction in major bleeding at 9 days with fondaparinux (2.2% vs 4.1%, P<0.001) At 30 days; death, MI, refractory ischemia: enoxaparin (8.6%), fondaparinux (8.0%) [HR 0.93, CI 0.84,1.02]. Death or MI: enoxaparin (6.8%), fondaparinux (6.2%) [HR 0.90, CI 0.81,1.01] Significant reduction in mortality at 6 months with fondaparinux (2.9% vs 3.5%, P=0.02)

    5. OASIS-5: Comparison of Fondaparinux and Enoxaparin in Acute Coronary Syndromes - RESULTS continued -

    6. OASIS-5: Comparison of Fondaparinux and Enoxaparin in Acute Coronary Syndromes - RESULTS continued -

    7. OASIS-5: Comparison of Fondaparinux and Enoxaparin in Acute Coronary Syndromes - RESULTS continued -

    8. OASIS-5: Comparison of Fondaparinux and Enoxaparin in Acute Coronary Syndromes - SUMMARY - Fondaparinux and enoxaparin equivalent in terms of primary endpoint (death, MI, refractory ischemia at 9 days) Fondaparinux significantly reduced risk of major bleed at 9 days At 30 days there was a trend towards lower rate of death, MI, refractory ischemia in patients treated with fondaparinux At 180 days, fondaparinux significantly reduced mortality

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