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Efficacy and Safety of Fondaparinux in Elderly Patients With ST-Segment Elevation Myocardial Infarction: Data From the OASIS 6 Trial Efficacy and Safety.

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Presentation on theme: "Efficacy and Safety of Fondaparinux in Elderly Patients With ST-Segment Elevation Myocardial Infarction: Data From the OASIS 6 Trial Efficacy and Safety."— Presentation transcript:

1 Efficacy and Safety of Fondaparinux in Elderly Patients With ST-Segment Elevation Myocardial Infarction: Data From 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

2 Efficacy and safety of fondaparinux in elderly patients with STEMI results 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 IIaII Fibrinogen Fibrin clot Extrinsic pathway Intrinsicpathway AT Xa Fondaparinux Xa Antithrombin Fondaparinux: Mechanism of Action Turpie AGG et al. N Engl J Med. 2001;344:619. THROMBIN Recycled

5 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. 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. UFH not indicated OASIS 6: Randomized, Double Blind, Double Dummy Lytics (SK, TPA, TNK, RPA), Primary PCI or no reperfusion (eg. late) StratificationStratification UFH indicated Randomization Fondaparinux 2.5 mg Placebo Fondaparinux 2.5 mg UFH

6 Primary Efficacy Outcome Death/MI at 30 Days Days Cumulative Hazard UFH/Placebo Fondaparinux HR % CI P=0.008

7 Primary Efficacy Outcome Death/MI at 30 Days No. of Events (%) ControlFondaHR95% CIP No. of Patients Death or Re-MI Death Reinfarction

8 Death at Study End (3 or 6 months) Days Cumulative Hazard UFH/Placebo Fondaparinux HR % CI P=0.029

9 Efficacy of Fondaparinux by Strata on Death/MI at Study End No. of Events (%) ControlFondaHR95% CI Stratum I (n = 5658) (Fonda vs. Placebo) Stratum II (n = 6434) (Fonda vs. UFH)

10 Pre-Specified Subgroup Analyses UFH/Plac better Hazard Ratio Overall None Thrombolytic Primary PCI < 112 >= % % Initial Reperfusion Rx GRACE Risk Score NUFH/Placebo Death or MI at 30 days Fonda Interaction P value Fonda better

11 Severe Hemorrhage definition 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 No. of Events ControlFondaHR95% CIP Severe Hemorrhage79 (1.3%) 61 (1.0%) Fatal ICH Retroperitoneal Cardiac Tamponade Hg drop ≥ 5 g/dL

13 Severe Hemorrhage by type of reperfusion therapy at 180 Days No. of Events ControlFondaHR95% CIP None1.8%1.6% Thrombolytics2.3%1.6% Primary PCI1.0%1.2%

14 Death and Net Clinical Benefit at Study End DeathDeath/MI/Stroke/ Severe Hemorrhage HR (95% CI) PHR (95% CI) P No Reperfusion 0.84 ( ) ( ) Thrombolytic0.85 ( ) ( ) o PCI1.09 ( ) ( ) 0.29 Overall0.88 ( ) ( ) 0.009

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 6 methods 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

18 Death and MI at 30 days ≥ 75 Yr

19 Death and MI at 30 days ≥ 75 Yr

20 Severe hemorrhage at 30 days

21 Net clinical benefit Death/MI/s ev.hemorr hage ControlFondadifferenceHR <7510.0%8.6%1.4% 0.85 ( ) >= %22.5%3.2% 0.87 ( )

22 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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