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Comparative analysis of antifibrinolytic medications in pediatric heart surgery
Sara K Pasquali1, Jennifer S Li, Xia He
1Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA. sara.pasquali@duke.edu
Insights
Aprotinin reduced bleeding and mortality in pediatric heart surgery, with similar efficacy to aminocaproic acid (ACA). Tranexamic acid (TXA) showed improved outcomes compared to aprotinin.
Area of Science:
- Pediatric Cardiac Surgery
- Pharmacology
- Critical Care Medicine
Background:
- Limited contemporary data exist comparing aprotinin with aminocaproic acid (ACA) and tranexamic acid (TXA) in pediatric heart surgery.
- Aprotinin's safety profile in children requires further investigation, as adult data may not directly translate.
Purpose of the Study:
- To compare the efficacy and safety of aprotinin, ACA, and TXA in pediatric patients undergoing heart surgery.
- To guide current clinical practice and inform future clinical trial design for antifibrinolytic use in this population.
Main Methods:
- Retrospective analysis of a large multicenter cohort using linked databases (Society of Thoracic Surgeons Congenital Heart Surgery Database and Pediatric Health Information Systems Database).
- Multivariable analysis adjusted for patient and center factors to evaluate efficacy and safety outcomes.
- Subgroup analyses were performed for neonates and patients undergoing redo sternotomy.
Main Results:
- Aprotinin use was associated with reduced hospital mortality/bleeding requiring surgical intervention overall and in the redo sternotomy subgroup.
- No significant benefit of aprotinin was observed in neonates, and there was no difference in renal failure requiring dialysis across groups.
- Comparative analysis showed no difference between aprotinin and ACA, but TXA was associated with significantly reduced mortality/bleeding compared to aprotinin, particularly in neonates.
Conclusions:
- Aprotinin appears safe and effective in reducing bleeding and mortality in children undergoing heart surgery, without increasing the need for dialysis.
- Aminocaproic acid (ACA) demonstrates similar efficacy to aprotinin.
- Tranexamic acid (TXA) offers superior outcomes in terms of reduced mortality and bleeding compared to aprotinin in this pediatric cohort.
Objectives:
Recent studies suggest adverse events associated with aprotinin in adults may not occur in children, and there is interest in further pediatric study of aprotinin. However, there are limited contemporary data comparing aprotinin with other available antifibrinolytics (aminocaproic acid [ACA] and tranexamic acid [TXA]) to guide current practice and aid in potential trial design. We performed a comparative analysis in a large multicenter cohort.
Methods:
The Society of Thoracic Surgeons Congenital Heart Surgery Database (2004-2008) was linked to medication data from the Pediatric Health Information Systems Database. Efficacy and safety outcomes were evaluated in multivariable analysis adjusting for patient and center factors overall and in neonates and those undergoing redo sternotomy.
Results:
A total of 22,258 patients (25 centers) were included: median age, 7.6 months (interquartile range, 2.6-43.4 months). Aprotinin (vs no drug) was associated with a significant reduction in combined hospital mortality/bleeding requiring surgical intervention overall (odds ratio [OR], 0.81; 95% confidence intervals [CI], 0.68-0.91) and in the redo sternotomy subgroup (OR, 0.57; 95% CI, 0.40-0.80). There was no benefit in neonates and no difference in renal failure requiring dialysis in any group. In comparative analysis, there was no difference in outcome in aprotinin versus ACA recipients. TXA (vs aprotinin) was associated with significantly reduced mortality/bleeding requiring surgical intervention overall (OR, 0.47; 95% CI, 0.30-0.74) and in neonates (OR, 0.30; 95% CI, 0.15-0.58).
Conclusions:
These observational data suggest aprotinin is associated with reduced bleeding and mortality in children undergoing heart surgery with no increase in dialysis. Comparative analyses suggest similar efficacy of ACA and improved outcomes associated with TXA.
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