Safety and Efficacy of Aprotinin in Coronary Artery Bypass Surgery: Insights from a Multi-Center Retrospective Study

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Abstract

Background Aprotinin was suspended in cardiac surgery following prior research indicating an association with elevated adverse clinical event risks. Recently, debate and divergent opinions regarding its use have emerged. This study aimed to assess the safety and efficacy of aprotinin by comparing outcomes in patients undergoing ONCAB before and after its suspension. Methods A multicenter retrospective cohort study was conducted to evaluate the efficacy and safety of aprotinin in ONCAB surgery. The aprotinin group (n = 919) included patients who received aprotinin and met the inclusion criteria prior to December 19, 2007. The control group (n = 935) included patients who received neither aprotinin nor any anti-fibrinolytic agents and met the inclusion criteria subsequent to December 19, 2007. Postoperative outcomes were compared between the two groups. Results In the aprotinin group, a discernible reduction in bleeding volume was observed, accompanied by a lower transfusion rate and volume, and a decreased reoperation incidence. Additionally, no significant difference was found in the composite endpoints ( P  > .05), which encompassed perioperative seizure, renal dysfunction, MI, stroke, DVT, PE, and all-cause mortality, when comparing the two groups. Notably, aprotinin use resulted in a marginal prolongation of hospital stay by 0.42 days ( P  = .041). Findings from the univariate analysis were corroborated by multivariable logistic regression, adjusting for baseline characteristics, thus yielding consistent results. Conclusions Aprotinin use in ONCAB surgery significantly minimized bleeding volume, transfusion rate and volume, and reoperation incidence, without elevating the risk of adverse clinical events.

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