Paul S.Myles MD, Julian A. Smith MS, FRACS, Jessica Kasza BSc(Hon), PhD, Brendan Silbert MB.BS, FANZCA, Mohandas Jayarajah MB.BS, FRCA, Thomas Painter MB.ChB, FANZCA, D. James Cooper MD, FCICM, Silvana Marasco PhD, FRACS, John McNeil PhD, F.R.A.C.P, Jean S.Bussières MD, FRCPC, Shay McGuinness MB.ChB, FANZCA, Kelly Byrne MB.ChB, FANZCAMatthew T.V. Chan MB.BS, PhD, Giovanni Landoni MD, Sophie Wallace BSc, MPH, Andrew Forbes MSc, PhD, ATACAS investigators and the ANZCA Clinical Trials Network.
The Journal of Thoracic and Cardiovascular Surgery
Available online 19 October 2018
Tranexamic acid reduces blood loss and transfusion requirements in cardiac surgery but may increase the risk of coronary graft thrombosis. We previously reported the 30-day results of a trial evaluating tranexamic acid for coronary artery surgery. Here we report the 1-year clinical outcomes.
Using a factorial design, we randomly assigned patients undergoing coronary artery surgery to receive aspirin or placebo and tranexamic acid or placebo. The results of the tranexamic acid comparison are reported here. The primary 1-year outcome was death or severe disability, the latter defined as living with a modified Katz activities of daily living score of less than 8. Secondary outcomes included a composite of myocardial infarction, stroke and death from any cause through to 1 year after surgery.
The rate of death or disability at 1 year was 3.8% in the tranexamic acid group and 4.4% in the placebo group (RR, 0.85; 95% CI, 0.64 to 1.13; P=0.27), and this did not significantly differ according to aspirin exposure at the time of surgery (interaction P=0.073). The composite rate of myocardial infarction, stroke and death up to 1 year after surgery was 14.3% in the tranexamic acid group and 16.4% in the placebo group (RR, 0.87; 95% CI, 0.76 to 1.00; P=0.053).
In this trial of patients having coronary artery surgery, tranexamic acid did not affect death or severe disability through to 1 year after surgery. Further work should be done to explore possible beneficial effects on late cardiovascular events.