Bivalirudin or heparin for systemic anticoagulation during pediatric extracorporeal membrane oxygenation: Multicenter retrospective study
Hamzah M, Seelhammer TG, Beshish AG, Byrnes J, Yabrodi M, Szadkowski A, Lutfi R, Andrijasevic N, Hock K, Worley S, Macrae DJ (2023) · Thrombosis Research · n=225
Study Profile
- Design
- multicenter retrospective study (children <18 years on ECMO June 2017-May 2020; UFH:bivalirudin matched 2:1 by age and ECMO type)
- Sample size (n)
- 225
- Intervention
- Bivalirudin anticoagulation in pediatric ECMO (n=75)
- Comparator
- Unfractionated heparin anticoagulation matched 2:1 (n=150)
- Primary endpoint
- Bleeding events, thrombotic events, hospital mortality, neurological outcomes
- Primary result
- Bivalirudin associated with lower bleeding (aOR 0.23, 95% CI 0.12-0.45, p<0.001), lower thrombosis (aOR 0.48, 95% CI 0.23-0.98, p=0.045), 50% lower hospital mortality (aOR 0.50, 95% CI 0.27-0.93, p=0.028), and higher intact neurological outcomes (OR 1.99, p=0.017)
- Follow-up duration
- Hospital discharge
- PMID
- 37517208
Key Findings
- Largest contemporary pediatric ECMO bivalirudin dataset (n=225)
- 77% relative reduction in bleeding events with bivalirudin
- 52% relative reduction in thrombotic events
- 50% reduction in hospital mortality
- 2-fold higher intact neurological outcomes at discharge
Limitations
- Retrospective design with potential selection bias
- 2:1 matching may not eliminate confounding by indication
- Anticoagulation targets varied across centers
- Mortality endpoint subject to competing risks bias
- Not applicable to whole-leech hirudotherapy
Clinical Implications
Hamzah 2023 provides the strongest contemporary observational signal favoring bivalirudin over heparin in pediatric ECMO across multiple outcomes. For ASH, this dataset demonstrates how the synthetic thrombin inhibitor pharmaceutical pathway generates aggregate evidence supporting practice change, structurally distinct from the K040187 device-leech US clinical practice. The multi-outcome signal strongly motivates definitive prospective RCT.
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