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
Характеристика исследования
- Дизайн
- multicenter retrospective study (children <18 years on ECMO June 2017-May 2020; UFH:bivalirudin matched 2:1 by age and ECMO type)
- Размер выборки (n)
- 225
- Вмешательство
- Bivalirudin anticoagulation in pediatric ECMO (n=75)
- Компаратор
- Unfractionated heparin anticoagulation matched 2:1 (n=150)
- Первичная конечная точка
- Bleeding events, thrombotic events, hospital mortality, neurological outcomes
- Основной результат
- 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)
- Длительность наблюдения
- Hospital discharge
- PMID
- 37517208
Ключевые выводы
- 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
Ограничения
- 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
Клиническое значение
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.
Связанные исследования
Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation
McMichael A, Weller J, Li X, Hatton L, Zia A, Raman L (2024)
Efficacy of Bivalirudin for Therapeutic Anticoagulation in COVID-19 Patients Requiring ECMO Support
Trigonis R, Smith N, Porter S, Anderson E, Jennings M, Kapoor R, Hage C, Moiz S, Garcia J, Rahman O (2021)
Bivalirudin versus heparin anticoagulation in patients receiving extracorporeal membrane oxygenation
Huang D, Guan Q, Qin J, Shan R, Wu J, Zhang C (2022)
Heparin-based versus bivalirudin-based anticoagulation in pediatric extracorporeal membrane oxygenation: A systematic review
Valdes CA, Sharaf OM, Bleiweis MS, Jacobs JP, Mumtaz M, Sharaf RM, Jeng EI, Peek GJ (2023)