O rganization to S trategies in Acute I schemic S yndromes Overall Efficacy of Fondaparinux vs Enoxaparin in VTE Prevention: Meta-analysis Fondaparinux better Enoxaparin better P = 0.000000000000000001 % odds reduction
Overall odds reduction for proximal DVT = 57.4% [CI: 72.3 - 35.6]; p = 10-6
Turpie et. al. Arch Intern Med 2002: 162: 1833-40
Baseline Characteristics Fonda (%) Therapies During Initial Hospitalization Fonda (%) 70% of patients recruited from centers with cath labs. MICHELANGELO: OASIS-5
2 of 3: Age>60, ST Δ, positive cardiac markers
opidogrel, IV GP II Clopidogrel, IV GP b/IIIa IIb/IIIa as per local practice Fondaparinux Enoxaparin Outcomes 1 mg/kg BID
•Primary: Efficacy: Death, MI, refractory ischemia 9 day Safety: Major bleeds Risk benefit: Death, MI, refractory ischemia, major bleeds
•Secondary: Above & each component (especially deaths) at 30 & 180 d • Hypothesis: First test non-inferiority, then test superiority Results: Major Bleeding: 9 Days 95% CI 0.45-0.62 ive Hazard p<<0.00001 Conclusions
Fondaparinux is “non-inferior” compared with enoxaparin at 9 days, with
substantially lower rates of important bleeds. The net benefit-risk balance clearly
Bleeding increases the risk of death significantly.
At one month and at 6 months there is a significant reduction in mortality with fondaparinux.
Strokes are also significantly reduced by fondaparinux, so that there is a clear
Consistent results are observed in those undergoing PCI (including early PCI) and
Clinical Implications :Results Treating 1000 ACS patients with fondaparinux instead of enoxaparin prevents:
- 10 deaths or MI- 4 strokes- 25 major bleeds
THE OASIS 5 TRIAL CLEARLY DEMONSTRATES THAT FONDAPARINUX IS
THE PREFERRED ANTICOAGULANT FOR TREATMENT OF ACS.
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