"Fondaparinux versus Enoxaparin in Acute Coronary Syndromes (OASIS-5 Trial)" The New England Journal of Medicine. 2006. 354(14):1464-1476. PubMed
Links to original sources: Wiki Journal Post Full Journal Article
Contents
1. Clinical Question 2. Bottom Line 3. Major Points 4. Guidelines 5. Design 6. Population 6.1 Inclusion Criteria 6.2 Exclusion Criteria 6.3 Baseline Characteristics 7. Interventions 8. Outcomes 8.1 Primary Outcome 8.2 Secondary Outcomes 9. Criticisms 10. Funding 11. Further Reading
In patients with acute coronary syndromes, does fondaparinux, compared to enoxaparin, reduce ischemic events without increasing bleeding?
Fondaparinux was noninferior to enoxaparin in preventing ischemic events in acute coronary syndromes, significantly reduced major bleeding, and improved long-term mortality and morbidity.
Fondaparinux, a synthetic pentasaccharide, potentially offers a better bleeding profile than enoxaparin while providing comparable anticoagulant effects for ischemic event reduction in acute coronary syndromes.
Recommendations for the use of fondaparinux may be influenced by these findings; however, specific guidelines resulting from this trial could vary by organization.
- Multicenter, double-blind, randomized controlled trial - N=20,078 patients with acute coronary syndromes - Fondaparinux (2.5 mg daily) or enoxaparin (1 mg per kg twice daily) - Mean follow-up: 6 months
- Inclusion Criteria: Patients with acute coronary syndromes, specifically unstable angina or myocardial infarction without ST-segment elevation, within 24 hours of symptom onset - Exclusion Criteria: Contraindications to low-molecular-weight heparin, recent hemorrhagic stroke, other indications for anticoagulation, serum creatinine ≥3 mg/dL
- Fondaparinux 2.5 mg subcutaneously once daily plus placebo enoxaparin - Enoxaparin 1 mg per kg subcutaneously twice daily plus placebo fondaparinux
- Primary Outcome: Death, myocardial infarction, or refractory ischemia at nine days; major bleeding events - Secondary Outcomes: Death, myocardial infarction, refractory ischemia, strokes at 30 days and at 180 days, major bleeding events throughout the study
- The study design and patient selection could potentially impact the generalizability of the trial results to broader acute coronary syndrome populations.
The trial was supported by Sanofi-Aventis, Organon, and GlaxoSmithKline. Disclosure of potential conflicts of interest by the trial's authors included receipt of consulting fees, lecture fees, and research grants from the pharmaceutical companies supporting the trial.
Additional readings include publications in cardiovascular medical journals discussing the impact of bleeding on acute coronary syndrome outcomes and the usage of fondaparinux in clinical practice.