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Efficacy and safety of fondaparinux in elderly patients with STEMI results of the OASIS 6 trial

Efficacy and Safety of Fondaparinux in Elderly Patients With ST-Segment Elevation Myocardial Infarction: Data From the OASIS 6 Trial Ron J.G. Peters, MD Cardiologist Department of Cardiology University of Amsterdam Amsterdam, Netherlands.

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Efficacy and safety of fondaparinux in elderly patients with STEMI results of the OASIS 6 trial

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  1. Efficacy and Safety of Fondaparinux in Elderly Patients With ST-Segment Elevation Myocardial Infarction: Data From the OASIS 6 TrialRon J.G. Peters, MDCardiologistDepartment of CardiologyUniversity of AmsterdamAmsterdam, Netherlands

  2. Efficacy and safety of fondaparinux inelderly patients with STEMIresults of the OASIS 6 trial RJ Peters, C Joyner, JP Bassand, R Afzal, S Chrolavicius, JW Eikelboom, SR Mehta, Fox KAA, S Yusuf, For the OASIS 6 investigators

  3. Disclosure Funded by Organon, Sanofi-Aventis, GSK All authors have received grants and honoraria from these companies and from several others

  4. Fondaparinux:Mechanism of Action Intrinsic pathway Extrinsic pathway Antithrombin Xa Xa AT AT AT Fondaparinux THROMBIN II IIa Recycled Fibrinogen Fibrin clot Turpie AGG et al. NEngl J Med. 2001;344:619.

  5. OASIS 6: Randomized, Double Blind, Double Dummy 12,000 Patients with STEMI < 12 h of symptom onset Inclusion: ST   2 mm prec leads or  1 mm limb leads Exclusion: Contra-ind. for anticoagulant, INR>1.8, pregnancy, ICH<12 mo. Lytics (SK, TPA, TNK, RPA), Primary PCI or no reperfusion (eg. late) Stratification UFH not indicated UFH indicated Randomization Randomization Fondaparinux 2.5 mg Placebo Fondaparinux 2.5 mg UFH

  6. Primary Efficacy OutcomeDeath/MI at 30 Days 0.12 UFH/Placebo 0.10 Fondaparinux 0.08 0.06 Cumulative Hazard HR 0.86 95% CI 0.77-0.96 P=0.008 0.04 0.02 0.0 0 3 6 9 12 15 18 21 24 27 30 Days

  7. Primary Efficacy OutcomeDeath/MI at 30 Days

  8. Death at Study End (3 or 6 months) 0.12 UFH/Placebo 0.10 Fondaparinux 0.08 0.06 Cumulative Hazard HR 0.88 95% CI 0.79-0.99 P=0.029 0.04 0.02 0.0 0 18 36 54 72 90 108 126 144 162 180 Days

  9. Efficacy of Fondaparinux by Strataon Death/MI at Study End

  10. Pre-Specified Subgroup Analyses Death or MI at 30 days Interaction P value N UFH/Placebo Fonda Overall 12092 11.2% 9.7% Initial Reperfusion Rx 0.04 None 2867 15.1 12.2 Thrombolytic 5436 13.6 10.9 Primary PCI 3789 4.9 6.0 GRACE Risk Score 0.03 < 112 5958 4.3 4.6 >=112 6134 18.0 14.5 0.5 0.7 0.8 1.0 1.2 1.4 1.6 2.0 Fonda better UFH/Plac better Hazard Ratio

  11. Severe Hemorrhagedefinition • Fatal • Intracranial • Cardiac tamponade • Clinically significant hemorrhage with decrease Hb > 5 gm/dl with each unit of transfusion counting for 1 gm/dl Hb

  12. Severe Hemorrhage at 9 Days

  13. Severe Hemorrhage by type of reperfusion therapy at 180 Days

  14. Death and Net Clinical Benefit at Study End

  15. Elderly patients with STEMI • Higher risk of adverse outcome • Higher risk of bleeding with thrombolytics • Higher risk of bleeding with anticoagulants • Net clinical outcome not predictable

  16. Elderly patients in OASIS 6methods • Post hoc analysis •  ≥75 years versus < 75 years • Primary endpoints as in main study • Net clinical benefit: death, MI, severe hemorrhage at 30 days

  17. Death and MI at 30 days ≥75 Yr ≥75 Yr ≥75 Yr ≥75 Yr

  18. Death and MI at 30 days ≥ 75 Yr ≥75 Yr ≥75 Yr ≥75 Yr

  19. Severe hemorrhage at 30 days

  20. Net clinical benefit

  21. conclusions In patients with STEMI who are not treated with PPCI: • The efficacy and safety of fondaparinux as compared to control treatment are consistent across age groups • Consequently, the net clinical benefit of fondaparinux is consistent across age groups

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