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OASIS-6

OASIS-6. The Sixth O rganization to A ssess S trategies in Acute I schemic S yndromes trial. OASIS-6: Background and hypothesis. There is a clear need for safe and effective antithrombotic agents for STEMI patients

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OASIS-6

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  1. OASIS-6 The Sixth Organization to Assess Strategies in Acute Ischemic Syndromes trial

  2. OASIS-6: Background and hypothesis • There is a clear need for safe and effective antithrombotic agents for STEMI patients • In clinical trials, unfractionated heparin, direct thrombin inhibitors, and enoxaparin have failed to demonstrate significant mortality reductions and lower bleeding rates in STEMI patients • Compared to standard antithrombotic therapies, does fondaparinux prevent CV events, revascularization, and mortality when initiated early in a broad range of STEMI patients? OASIS-6 Trial Group. JAMA. 2006;295:1519-30.

  3. OASIS-6: Study design Patients with STEMI randomized <12 h of symptom onsetN = 12,092 Stratum I:UFH not indicated (receiving thrombolytics)(n = 5658) Stratum II:UFH indicated(receiving tPA or scheduled PCI)(n = 6434) Fondaparinux 2.5 mg qd + placebo*(n = 3213) UFH 60 IU/kg IV bolus/12 IU/kg 24–48 h infusion + placebo*(n = 3221) Fondaparinux 2.5 mg qd*(n = 2823) Placebo*(n = 2835) Primary outcome: Composite of death or reinfarction at 30 daysMain safety outcome: Severe bleeding *Up to 8 days (or earlier discharge) OASIS-6 Trial Group. JAMA. 2006;295:1519-30.

  4. OASIS-6: Baseline characteristics Strata 1 and 2 combined OASIS-6 Trial Group. JAMA. 2006;295:1519-30.

  5. OASIS-6: Medical history Strata 1 and 2 combined % OASIS-6 Trial Group. JAMA. 2006;295:1519-30.

  6. OASIS-6: Concomitant in-hospital medications following randomization Strata 1 and 2 combined % Other medications <1% each OASIS-6 Trial Group. JAMA. 2006;295:1519-30.

  7. OASIS-6: Treatment effect on primary efficacy outcome at 30 days Composite of death, MI 0.14 0.12 0.10 0.08 Cumulative event rate 0.06 HR 0.86(0.77–0.96)P = 0.008 0.04 0.02 0 0 3 6 9 12 16 18 21 24 27 30 Days UFH or placebo Fondaparinux OASIS-6 Trial Group. JAMA. 2006;295:1519-30.

  8. OASIS-6: Severe bleeding at 30 days Modified TIMI criterion 0.016 0.014 0.012 0.010 Cumulative event rate 0.008 HR 0.79(0.58–1.09)P = 0.15 0.006 0.004 0.002 0 0 3 6 9 12 16 18 21 24 27 30 Days UFH or placebo Fondaparinux OASIS-6 Trial Group. JAMA. 2006;295:1519-30.

  9. OASIS-6: Net clinical benefit Death, MI, severe bleeding % UFH or placebo Favors fondaparinux Favors UFH or placebo Fondaparinux P 9 days 30 days 6 months 7.7 10.0 12.9 9.3 11.6 14.7 0.003 0.005 0.005 0.8 1.0 1.2 Hazard ratio(95% CI) OASIS-6 Trial Group. JAMA. 2006;295:1519-30.

  10. OASIS-6: Treatment effect on primary outcome at 30 days–Subgroup analyses Composite of death, MI at 30 days % Favors fondaparinux Favors UFH or placebo UFH or placebo Characteristic Fondaparinux Stratum UFH not indicated UFH indicated Initial reperfusion therapy None Thrombolytic Primary PCI 11.2 8.3 12.2 10.9 6.0 14.08.7 15.1 13.6 4.9 0.5 1 2.0 Hazard ratio(95% CI) OASIS-6 Trial Group. JAMA. 2006;295:1519-30.

  11. OASIS-6: Reduction in death and MI at study end Death MI 0.16 0.16 0.14 0.14 HR 0.81(0.67–0.97)P = 0.03 0.12 0.12 0.10 0.10 Cumulativeevent rate 0.08 0.08 HR 0.88(0.79–0.99)P = 0.03 0.06 0.06 0.04 0.04 0.02 0.02 0 0 0 30 60 90 120 150 180 0 30 60 90 120 150 180 Days Days UFH or placebo Fondaparinux All patients followed for 3 months; n = 6976 followed for 6 months OASIS-6 Trial Group. JAMA. 2006;295:1519-30.

  12. OASIS-6: Conclusion • Primary efficacy outcome at 30 days Fondaparinux significantly reduced death and reinfarction vs UFH/placebo • Main safety outcome Trend to lower rate of severe bleeding • Overall, results occurred early (9 days) and remained consistent through study end Significant reduction in death (12%, P = 0.03) and MI (19%, P = 0.03) • Benefit/risk balance Rate of combined death, MI, and severe bleeding was significantly lower for fondaparinux vs UFH/placebo • Subgroup analysis Benefit shown in 5436 patients who received thrombolytic therapyLittle benefit in 3789 patients who underwent primary PCI OASIS-6 Trial Group. JAMA. 2006;295:1519-30.

  13. OASIS-6: Summary • Fondaparinux demonstrated a moderate reduction in mortality and reinfarction vs UFH/placebo • Unlike other antithrombotic agents (eg, LMW heparin, direct thrombin inhibitors, intravenous antiplatelet agents), fondaparinux reduced deaths and reinfarction without increased bleeding or hemorrhagic stroke • There appears to be little advantage in using fondaparinux as the initial treatment in patients undergoing primary PCI OASIS-6 Trial Group. JAMA. 2006;295:1519-30.

  14. The OASIS program: Safety and efficacy of fondaparinux in a broad range of patients with ACS • OASIS-5: N = 20,078 with UA/NSTEMI: Fondaparinux vs enoxaparin • Similar efficacy in reducing risk of death, MI, and refractory ischemiaat 9 days • Significantly lower rate of major bleeding (P < 0.001) at 9 days • OASIS-6: N = 12,092 with STEMI: Fondaparinux vs UFH/placebo • Significantly lower rate of death and reinfarction at 30 days (P = 0.008) • Benefit principally in patients who did not undergo primary PCI • Nonsignificant trend towards lower rate of severe bleeding at 30 days • In both trials, efficacy and net clinical benefit remained consistent through study end OASIS-5 Investigators. N Engl J Med. 2006; epublished March 14.OASIS-6 Trial Group. JAMA. 2006;295:1519-30.

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