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

摘要

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.