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II
EFFECTS OF FONDAPARINUX ON MORTALITY AND REINFARCTION IN PATIENTS WITH ACUTE ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (OASIS 6)
SR Mehta, S Yusuf
Fondaparinux is a synthetic factor Xa inhibitor that has been shown to reduce major bleeding by 50% and mortality by 17% compared with enoxaparin in the OASIS 5 trial of patients with unstable angina/NSTEMI. The OASIS 6 trial sought to evaluate the effects of fondaparinux compared with standard care (either UFH or placebo) in patients with STEMI. Background reperfusion therapies included thrombolytic therapy, primary PCI or no reperfusion (eg, late presentation to hospital to contraindication to lytic therapy). The results demonstrate a clear reduction in all-cause mortality and re-infarction at 30 days with fondaparinux. Similar benefit was observed when fondaparinux was compared with UFH and with placebo. These benefits were acheived with no increase in major bleeding. The benefits of fondaparinux were observed in those patients receiving thrombolytic therapy or no reperfusion, with no significant benefit among those receiving primary PCI.
Hamilton, Ontario
Death/re-MI was reduced with fondaparinux (11.2% vs 9.7%, HR 0.86; p=0.006) with no heterogeneity in the two strata by planned heparin use. There were significant reductions in mortality throughout the study. Benefits were observed in those receiving thrombolytics (HR 0.84, p=0.045) and those not eligible for reperfusion therapy (HR 0.77, p=0.002). There were fewer severe bleeds (81 vs 62), fatal bleeds (49 vs 35) and cardiac tamponade (48 vs 28, p=0.02) with fondaparinux.
CONCLUSIONS: In patients with STEMI, fondaparinux significantly reduces mortality and reinfarction, without increasing bleeding.
DESIGN: Randomized, double blind (n=12,092).