A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF APROTININ FOR REDUCING BLOOD-LOSS AND THE REQUIREMENT FOR DONOR-BLOOD TRANSFUSION IN PATIENTS UNDERGOING REPEAT CORONARY-ARTERY BYPASS-GRAFTING

Background Aprotinin is a serine protease inhibitor that reduces blood loss and transfusion requirements when administered prophylactically to cardiac surgical patients. To examine the safety and dose-related e fficacy of aprotinin, a prospective, multicenter. placebo-controlled t rial was conducted in patients undergoing repeat coronary artery bypas s graft (CABG) surgery. Methods and Results Two hundred eighty-seven p atients were randomly assigned to receive either high-dose aprotinin, low-dose aprotinin, pump-prime-only aprotinin, or placebo. Drug effica cy was determined by the reduction in donor-blood transfusion up to po stoperative day 12 and in postoperative thoracic-drainage volume. The percentage of patients requiring donor-red-blood-cell (RBC) transfusio ns in the high- and low-dose aprotinin groups was reduced compared wit h the pump-prime-only and placebo groups (high-dose aprotinin, 54%; lo w-dose aprotinin, 46%; pump-prime only, 72%; and placebo, 75%; overall P=.001), The number of units of donor RBCs transfused was significant ly lower in the aprotinin-treated patients compared with placebo (high -dose aprotinin, 1.6+/-0.2 U; low-dose aprotinin, 1.6+/-0.3 U; pump-pr ime-only, 2.5+/-0.3 U; and placebo, 3.4+/-0.5 U; P=.0001). There was a lso a significant difference in total blood-product exposures among tr eatment groups (high-dose aprotinin, 2.2+/-0.4 U; low-dose aprotinin, 3.4+/-0.9 U; pump-prime-only, 5.1+/-0.9 U; placebo, 10.3+/-1.4 U). The re were no differences among treatment groups for the incidence of per ioperative myocardial infarction (MI). Conclusions This study demonstr ates that high- and low-dose aprotinin significantly reduces the requi rement for donor-blood transfusion in repeat CABG patients without inc reasing the risk for perioperative MI.