APROTININ FOR CORONARY-BYPASS OPERATIONS - EFFICACY, SAFETY, AND INFLUENCE ON EARLY SAPHENOUS-VEIN GRAFT PATENCY - A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

The purpose of this study was to evaluate the efficacy and safety of a protinin in a U.S. population of patients undergoing coronary artery b ypass grafting. Early vein graft patency rates were assessed by ultraf ast computed tomography. A total of 216 patients at five centers were randomized to receive either high-dose aprotinin or placebo during the operation; 151 patients underwent primary operation, and 65 underwent repeat procedures. Total blood product exposures in the primary group were 2.2 per patient receiving aprotinin as compared with 5.7 per pat ient receiving placebo (p = 0.010); The repeat group had 0.3 exposures per patient receiving aprotinin as compared with 10.7 per patient rec eiving placebo (p = <0.001). Consistent reductions in the percent of p atients requiring donor red blood cells and in the number of units of platelets, fresh frozen plasma, and cryoprecipitate required were asso ciated with the use of aprotinin in both primary and repeat groups, Mo rtality was 5.6% in the aprotinin group and 3.7% in the placebo group (p = 0.517). In the primary group, clinical diagnoses of myocardial in farction were made in 8.9% of patients receiving aprotinin as compared with 5.6% of the patients receiving placebo (p = 0.435). In the repea t group, infarctions occurred in 10.3% of patients receiving aprotinin and 8.3% of patients receiving placebo (p = 1.000). Secondary analysi s of electrocardiograms and available enzyme data showed no significan t difference in infarction rates between the treatment groups. There w as no difference in clinically significant renal dysfunction. The earl y vein graft patency rates were 92.0% in the aprotinin group and 95.1% in the placebo group (p = 0.248). In this study, aprotinin was effect ive in reducing bleeding and blood product transfusion rates, and its use was not associated with an increase in complications. An adverse e ffect on early vein graft patency rates was not demonstrated, but the number of grafts assessed was insufficient for absolute conclusions in this regard.