Aprotinin is without benefit in high risk patients

Abstract

BACKGROUND: Severe bleeding is relatively frequent in cardiac surgery and associated with increased morbidity and mortality. Blood transfusion benefits in the acute phase, but carries potential complications1. The anti-fibrinolytic drug Aprotinin (AP) and the lysine analogue tranexamic acid (TA) are used to attenuate blood loss2. However, studies documented severe adverse effect after AP3- 4 and the use stopped in routine practice. Risk from bleeding may be increased in fragile patients and in high risk procedures. Thus, some continued the use of AP based on individual evaluations of risks and benefits in selected patients. The purpose of the study was to evaluate the beneficial effects and potential adverse outcomes in high risk cardiac surgery patients receiving AP. METHODS: Consecutive adult on-pump cardiac surgery patients 2007-2014 (N=6,341). Patient characteristics and surgical procedures are primarily described by EuroSCORE. The decision of AP or TA treatment was at the discretion of the surgeon in charge. Propensity score matching was used to reduce the risk of bias due to confounding and non-random assignment of transfusion therapy. Covariates were adequately balanced after propensity score matching (Figure1). Conditional logistic regression was used to estimate crude and adjusted risks. RESULTS: AP was administered to 598 (9.4%). The remaining patients received TA. 513 of the 598 (85.8%) was matched with a TA patient. Baseline parameters before and after propensity score matching are summarized in Table 1. Patients receiving AP had discrete indications, however not statistical significant, of lower postoperative drainage, less frequent re-do surgery and less treatment with fibrinogen and factor VII A (table 2). Patients receiving AP received significant more often RBC's (50.1% vs. 43.5%; P=0.035; Table 2). The crude regression analysis demonstrated that use of AP was followed by a higher frequency of new postoperative dialysis. However, no independent impact was seen in the adjusted analysis (table 3). Perioperative vasoconstrictors and transfusions are the primary factors with individual negative impact on postoperative dialysis and 6mth mortality (table 4). CONCLUSION: In this group of relatively high risk patients Aprotinin had no statistical significant beneficial impact on perioperative bleeding. Although the negative impact was less than previous reported in standardized cardiac cases, there are still indications of negative impact on severe outcome parameters.