The Effect of Aprotinin on Outcome after Coronary-Artery Bypass Grafting
Andrew D. Shaw, M.B., Mark Stafford-Smith, M.D., William D. White, M.P.H., Barbara Phillips-Bute, Ph.D., Madhav Swaminathan, M.D., Carmelo Milano, M.D., Ian J. Welsby, M.B., Solomon Aronson, M.D., Joseph P. Mathew, M.D., Eric D. Peterson, M.D., M.P.H., and Mark F. Newman, M.D.
Background Aprotinin has recently been associated with adverseoutcomes in patients undergoing cardiac surgery. We reviewedour experience with this agent in patients undergoing cardiacsurgery at Duke University Medical Center.
Methods We retrieved data on 10,275 consecutive patients undergoingsurgical coronary revascularization at Duke between January1, 1996, and December 31, 2005. We fit data to a logistic-regressionmodel predicting each patient's likelihood of receiving aprotininon the basis of preoperative characteristics and to models predictinglong-term survival (up to 10 years) and decline in renal function,as measured by increases in serum creatinine levels.
Results A total of 1343 patients (13.2%) received aprotinin,6776 patients (66.8%) received aminocaproic acid, and 2029 patients(20.0%) received no antifibrinolytic therapy. All patients underwentcoronary-artery bypass grafting, and 1181 patients (11.5%) underwentcombined coronary-artery bypass grafting and valve surgery.In the risk-adjusted model, survival was worse among patientstreated with aprotinin, with a main-effects hazard ratio fordeath of 1.32 (95% confidence interval [CI], 1.12 to 1.55) forthe comparison with patients receiving no antifibrinolytic therapy(P=0.003) and 1.27 (95% CI, 1.10 to 1.46) for the comparisonwith patients receiving aminocaproic acid (P=0.004). As comparedwith the use of aminocaproic acid or no antifibrinolytic agent,aprotinin use was also associated with a larger risk-adjustedincrease in the serum creatinine level (P<0.001) but notwith a greater risk-adjusted incidence of dialysis (P=0.56).
Conclusions Patients who received aprotinin had a higher mortalityrate and larger increases in serum creatinine levels than thosewho received aminocaproic acid or no antifibrinolytic agent.
Source Information
From the Departments of Anesthesiology (A.D.S., M.S.-S., W.D.W., B.P.-B., M.S., I.J.W., S.A., J.P.M., M.F.N.) and Surgery (C.M.) and the Duke Clinical Research Institute (E.D.P.), Duke University Medical Center, Durham, NC.
Address reprint requests to Dr. Shaw at the Department of Anesthesiology, Duke University Medical Center, Durham, NC 27516, or at andrew.shaw{at}duke.edu.
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