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.
CTSNet classification
20
37
Abbreviations and Acronyms
ACA
aminocaproic acid
CI
confidence interval
EACTS
European Association for Cardiothoracic Surgery
ICD-9
International Classification of Diseases, Ninth Revision
OR
odds ratio
PHIS
Pediatric Health Information Systems
STS-CHS
The Society of Thoracic Surgeons Congenital Heart Surgery (Database)
TXA
tranexamic acid
Cited by (0)
This study was supported by National Heart, Lung, and Blood Institute Grant1RC1HL099941-01, under the 2009 American Recovery and Reinvestment Act. Dr Pasquali: Grant support National Heart, Lung, and Blood Institute (1K08HL103631-01), and American Heart Association Mid-Atlantic Affiliate Clinical Research Program. Dr Shah: Grant support National Institute of Allergy and Infectious Diseases (K01 AI73729) and Robert Wood Johnson Foundation Physician Faculty Scholar program. Dr J Jacobs: Chair, Society of Thoracic Surgeons Congenital Heart Surgery Database Task Force, and medical advisor and shareholder, CardioAccess. Dr Peterson: Principal Investigator, Society of Thoracic Surgeons National Databases Analytic Center.
Disclosures: Authors have nothing to disclose with regard to commercial support.
