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
Hirulog in the treatment of unstable angina. Results of the Thrombin Inhibition in Myocardial Ischemia (TIMI) 7 trial
Fuchs J, Cannon CP (1995)
Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomised controlled trial
Mehran R, Lansky AJ, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Wong SC, Nikolsky E, Gambone L, Vandertie L, Parise H, Dangas GD, Stone GW (2009)
Experience with pharmacologic leeching with bivalirudin for adjunct treatment of venous congestion of head and neck reconstructive flaps
Harun A, Kruer RM, Lee A, Boahene K, Byrne PJ, Richmon JD (2018)
Heparin and Bivalirudin in Percutaneous Coronary Intervention for Acute Coronary Syndromes: A Review Article
Wang G, Qi K, Li X, Zuo S, Zhang R, Zhao Y, Sun S, Zhang J, Liu X (2024)