Safety and Efficacy of Caproamin Fides and Tranexamic Acid Versus Placebo in Patients Undergoing Coronary Artery Revascularization

Abstract

INTRODUCTION Excessive fibrinolysis contributes to post-cardiopulmonary bypass bleeding. Tranexamic Acid (TXA) and Caproamin Fides are synthetic lysine analogues that inhibit plasminogen-fibrin binding. The present study aimed to compare TXA and Caproamin Fides versus placebo in patients undergoing elective coronary artery revascularization. METHODS We analyzed perioperative data of 300 adult patients undergoing coronary artery revascularization. Patients were randomly allocated to receive TXA (n=100), Caproamin Fides (n=100) or placebo (n=100) during perioperative time. Mediastinal bleeding during the first 24 hours post-operation, transfusion requirement and post-surgical complications were assessed. RESULTS Most descriptive and intra-operative parameters were well comparable between the 3 study groups. Except for mean number of packed red blood cell (PRBC) units transfused during ICU stay (P=0.01), patients in the Caproamin Fides and TXA groups did not show any statistically significant differences regarding transfusion of blood products during peri-operative period. There was no evidence of a significant difference in mediastinal blood loss during the first 24 hours post-operation between the patients receiving TXA or placebo, while patients in the Caproamin Fides group had significantly lower mediastinal bleeding than the other 2 groups (Caproamin Fides vs. placebo, P=0.002, <0.001 and <0.001 at 6, 12 and 24 hours post-operation; Caproamin Fides vs. TXA, P=0.009, 0.003, <0.001 at 6, 12 and 24 hours post-operation). The incidence of postoperative complications were comparable between Caproamin Fides and TXA groups (P>0.05). CONCLUSION In conclusion, Caproamin Fides seems to be superior to TXA regarding the blood saving effects in patients undergoing coronary artery revascularization.