Tranexamic Acid in On-Pump Coronary Artery Bypass Grafting Without Clopidogrel and Aspirin Cessation: Randomized Trial and 1-Year Follow-Up

Background. Dual antiplatelet therapy is widely used in patients with coronary artery disease and increases the risk of excessive bleeding and transfusion in those undergoing coronary artery bypass grafting (CABG). Methods. The study was a prospective, randomized, double-blinded and placebo-controlled trial. Patients undergoing primary and isolated on-pump CABG with their last dose of clopidogrel and aspirin less than 7 days preoperatively were randomly assigned to receive tranexamic acid (15 mg/kg before surgical incision and 15 mg/kg after protamine neutralization) or a corresponding volume of saline solution. The primary outcome was allogeneic erythrocyte transfusion. Results. Randomly assigned participants were 120 adults among whom 117 were analyzed, 58 in the tranexamic acid group and 59 in the placebo group. As compared with placebo, tranexamic acid reduced allogeneic erythrocyte requirement-both the volume transfused (4.84 +/- 5.85 versus 9.36 +/- 11.41 units; mean difference -4.52 units; 95% interval confidence [CI], -7.85 to -1.19 units; p < 0.001) and the ratio exposed (72.4% versus 91.5%; risk difference in percentage point, -19.1; 95% CI, -32.6 to -5.59; relative risk, 0.79; 95% CI, 0.66 to 0.94; p = 0.007)-blood loss (1069.1 +/- 565.5 mL versus 1449.8 +/- 899.8 mL; mean difference, -380.7 mL; 95% CI, -656.4 to -104.9 mL; p = 0.005), major bleeding (50.0% versus 78.0%; risk difference, -28.0; 95% CI, -44.6 to -11.3; relative risk, 0.64; 95% CI, 0.48 to 0.86; p = 0.002), and reoperation (0.0% versus 10.2%; risk difference, -10.2; 95% CI, -17.9 to -2.46; relative risk, 0.08; 95% CI, 0.00 to 1.36; p = 0.01). Conclusions. Tranexamic acid significantly reduced blood loss, major bleeding, reoperation, and allogeneic transfusion in patients undergoing primary and isolated on-pump CABG without clopidogrel and aspirin cessation. (Ann Thorac Surg 2013;95:795-802) (C) 2013 by The Society of Thoracic Surgeons