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Aprotinin in Cardiac Surgery Patients: Is the Risk Worth the Benefit?

S. C. Stamou, S. L. Camp, M. K. Reames, E. Skipper, M. R. Stiegel, J. Madjarov, L. Watts, F. Robicsek, K. W. Lobdell. Carolinas Heart and Vascular Institute, Charlotte, NC,


BACKGROUND:
Aprotinin is the only FDA-approved agent to reduce hemorrhage related to cardiac surgery and its safety and efficacy has been extensively studied. Our study sought to investigate the antifibrinolytic efficacy and adverse effects of aprotinin compared with e-aminocaproic acid ( EACA) in cardiac surgery operations.
METHODS:
Between January 2002 to December 2006, 2,129 patients had coronary artery bypass grafting (CABG), valve surgery, or CABG and valve surgery in our institution with the use of aprotinin (1,920) or EACA (209). Logistic regression and propensity score analysis were used to adjust for imbalances in the patients’ preoperative characteristics. The propensity score adjusted sample included 618 patients who received aprotinin and 209 patients who received EACA (1 to 3 matching).
RESULTS:
In univariate analysis, the risk of cardiac arrest was higher in the aprotinin group (aprotinin 1.9% Vs. EACA 0%, p=0.045). Results of multivariate logistic regression analysis with propensity score adjustment are shown in Table.
CONCLUSIONS:
Aprotinin decreased the rate of postoperative blood transfusion but increased the risk of acute renal failure and cardiac arrest after cardiac surgery when compared to EACA.
Propensity Score adjusment of Postoperative Outcomes
Odds Ratio95% Confidence IntervalsP-Value
STROKE0.390.12 - 1.310.13
SEPSIS2.890.66 - 12.600.16
ACUTE RENAL FAILURE2.741.16 - 6.520.02
REOPERATION FOR BLEEDING0.530.27 - 1.050.07
BLOOD TRANSFUSION0.660.48 - 0.910.01
MEDIASTINITIS3.720.48 - 28.950.21
OPERATIVE MORTALITY3.240.75 - 14.010.12

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