Aprotinin Re-visited: Still Room for Concern

Objectives: To evaluate differences in effects of Aprotinin compared to Tranexamic acid on bleeding and severe postoperative adverse outcomes such as new thromboembolic events, dialysis, and mortality in a large cohort of high-risk patients undergoing cardiac surgery. Methods: All adult standard on-pump cardiac surgery procedures (N=6341) from January 1, 2007 through December 31, 2014. We performed a propensity score matched analysis, aiming to match each patient receiving Aprotinin with a control receiving Tranexamic acid, (N=513 in each group).Primary short-term outcomes were 30- day mortality, incidence of new postoperative dialysis, myocardial infarction, or stroke during the index hospitalization. Primary longterm outcomes were need for re-do coronary artery bypass grafting, coronary angiography, or percutaneous coronary intervention within six month, as well as 6-month mortality. Results: Aprotinin patients received a significantly higher rate of red blood cell transfusion compared to patients in the control group (50.1% vs. 43.5%; p=0.035). Aprotinin was followed by a higher risk of new postoperative dialysis with a crude OR 1.78 (1.18-2.67). When adjusted for relevant confounders, the association was no longer statistically significant. Patients in the Aprotinin group had significantly increased S-creatinine levels from day one after surgery and throughout the first postoperative week. The short- and longterm mortality was comparable between groups, as were the risk of postoperative ischaemic events. Conclusions: Aprotinin was associated with a significantly higher red blood cell transfusion rate, and an enhanced risk of impaired renal function and new dialysis compared to patients treated with Tranexamic acid, and it thus remains an unattractive alternative in high-transfusion-risk patients. Keywords: Aprotinin; Tranexamic Acid; Cardiac Surgical Procedures; Erythrocyte Transfusion; Dialysis; Propensity Scor