Aprotinin Use in Cardiac Surgery Patients at Low Risk for Requiring Blood Transfusion

Objectives: Methods: Three hundred thirty-five patients who underwent primary cardiac surgery involving cardiopulmonary bypass between November 1, 2003, and December 31, 2005, and were considered at low risk for requiring postoperative blood transfusion; 162 patients received aprotinin and 173 patients received aminocaproic acid (control).

Results: Comparison of patients in the aprotinin group versus those in the aminocaproic acid group revealed no difference in total donor exposures to blood products (1.86 vs 1.16 units/patient, p=0.07), total packed red blood cells (PRBCs) received (1.25 vs 0.86 units/patient, p=0.09), postoperative donor exposures to blood products (0.91 vs 0.48 unit/patient, p=0.13), or postoperative PRBCs received (0.61 vs 0.40 unit/patient, p=0.23). No difference was noted in any other clinical outcome in the aprotinin group versus the aminocaproic acid group, including postoperative azotemia (13.0% vs 10.4%, p=0.46), new onset of atrial fibrillation (14.8% vs 15.0%, p=0.95), myocardial infarction, stroke, or death. Mean +/- SD total hospital length of stay was similar in the aprotinin group versus the aminocaproic acid group (8.1 +/- 3.8 vs 7.4 +/- 2.8 days, p=0.08), but length of stay from surgery to discharge was longer in the aprotinin group than in the aminocaproic acid group (5.9 +/- 0.17 vs 5.4 +/- 0.12 days, p=0.032).

Conclusion: Although aprotinin appeared to be safe in this low-risk patient population, it was not more effective than aminocaproic acid in reducing blood product use after cardiac surgery. More robust evidence is needed from a controlled randomized trial to demonstrate the safety, efficacy, and pharmacoeconomic benefit of aprotinin.