Cost-benefit and efficacy of aprotinin compared with epsilon-aminocaproic acid in patients having repeated cardiac operations - A randomized, blinded clinical trial

Background: Aprotinin and epsilon-aminocaproic acid are routinely used to reduce bleeding during cardiac surgery, The marked difference in average wholesale cost between these two drug therapies (aprotinin, $1,080 vs. epsilon-aminocaproic acid, $11) has generated significant controversy regarding their relative efficacies and costs, Methods: in a multicenter, randomized, prospective, blinded trial patients having repeated cardiac surgery received either a high-dose regimen of aprotinin (total dose, 6 x 10(6) kallikrein inactivator units) or epsilon-aminocaproic acid (total dose, 270 mg/kg). Results: Two hundred four patients were studied Overall (data are median [25th-75th percentiles]), aprotinin-treated patients had less postoperative thoracic drainage (511 ml[383-805 mi] vs. 655 mi [464-1,045 ml]: P -0.016) and received fewer platelet transfusions (0 [range, 0-1] vs. [range, 0-2]; P = 0.036). The surgical field was more likely to be considered free of bleeding in aprotinin-treated patients (44% vs. 26%; P = 0.012), No differences, however, were seen in allogeneic erythrocyte transfusions or in the time required for chest closure, Overall, direct and indirect bleeding-related costs were greater in aprotinin-than in epsilon-aminocaproic acid-treated patients ($1,813 [$1,476-2,605] vs. $1,088 [range, $511-2,057]; P = 0.0001). This difference in cost per case varied in magnitude among sites but not in direction. Conclusions: Aprotinin was more effective than epsilon-aminocaproic acid at decreasing bleeding and platelet transfusions. epsilon-aminocaproic acid however, was the more cost-effective therapy over a broad range of estimates for bleeding-related costs in patients undergoing repeated cardiac surgery, A cost-benefit analysis using the lower cost of half-dose aprotinin ($540) still resulted in a significant cost advantage using epsilon-aminocaproic therapy (P = 0.022).