OASIS-5
Trial question
What is the effect of fondaparinux in patients with acute coronary syndromes?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
38.0% female
62.0% male
N = 20078
20078 patients (7699 female, 12379 male).
Inclusion criteria: patients with acute coronary syndromes.
Key exclusion criteria: contraindications to LMWH, recent hemorrhagic stroke, indications for anticoagulation other than an acute coronary syndrome, or a serum creatinine level of at least 3 mg/dL.
Interventions
N=10057 fondaparinux (2.5 mg daily for a mean of 6 days).
N=10021 enoxaparin (1 mg/kg body weight BID for a mean of 6 days).
Primary outcome
Death, MI, or refractory ischemia at 9 days
5.8%
5.7%
5.8 %
4.3 %
2.9 %
1.4 %
0.0 %
Fondaparinux
Enoxaparin
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in death, MI, or refractory ischemia at 9 days (5.8% vs. 5.7%; HR 1.01, 95% CI 0.9 to 1.13).
Secondary outcomes
No significant difference in death or MI at day 30 (6.2% vs. 6.8%; HR 0.9, 95% CI 0.81 to 1.01).
Significant decrease in death at 30 days (2.9% vs. 3.5%; HR 0.83, 95% CI 0.71 to 0.97).
Significant decrease in death, MI, refractory ischemia, or major bleeding at day 30 (10.2% vs. 12.4%; HR 0.82, 95% CI 0.75 to 0.89).
Safety outcomes
Significant differences in major bleeding at 9 days (2.2% vs. 4.1%), at 30 days (3.1% vs. 5.0%), and at 180 days (4.3% vs. 5.8%).
Conclusion
In patients with acute coronary syndromes, fondaparinux was noninferior to enoxaparin with respect to death, MI, or refractory ischemia at 9 days.
Reference
Fifth Organization to Assess Strategies in Acute Ischemic Syndromes Investigators, Yusuf S, Mehta SR et al. Comparison of fondaparinux and enoxaparin in acute coronary syndromes. N Engl J Med. 2006 Apr 6;354(14):1464-76.
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