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Written by Paul S. Myles, M.P.H., M.D., Julian A. Smith, F.R.A.C.S., Andrew Forbes, Ph.D., Brendan Silbert, M.B., B.S., Mohandas Jayarajah, M.B., B.S., Thomas Painter, M.B., Ch.B., D. James Cooper, M.D., Silvana Marasco, Ph.D., John McNeil, Ph.D., Jean S. Bussières,
Tranexamic acid reduces the risk of bleeding among patients undergoing cardiac surgery, but it is unclear whether this leads to improved outcomes. Furthermore, there are concerns that tranexamic acid may have prothrombotic and proconvulsant effects.
In a trial with a 2-by-2 factorial design, we randomly assigned patients who were scheduled to undergo coronary-artery surgery and were at risk for perioperative complications to receive aspirin or placebo and tranexamic acid or placebo. The results of the tranexamic acid comparison are reported here. The primary outcome was a composite of death and thrombotic complications (nonfatal myocardial infarction, stroke, pulmonary embolism, renal failure, or bowel infarction) within 30 days after surgery.
Of the 4662 patients who were enrolled and provided consent, 4631 underwent surgery and had available outcomes data; 2311 were assigned to the tranexamic acid group and 2320 to the placebo group. A primary outcome event occurred in 386 patients (16.7%) in the tranexamic acid group and in 420 patients (18.1%) in the placebo group (relative risk, 0.92; 95% confidence interval, 0.81 to 1.05; P=0.22). The total number of units of blood products that were transfused during hospitalization was 4331 in the tranexamic acid group and 7994 in the placebo group (P<0.001). Major hemorrhage or cardiac tamponade leading to reoperation occurred in 1.4% of the patients in the tranexamic acid group and in 2.8% of the patients in the placebo group (P=0.001), and seizures occurred in 0.7% and 0.1%, respectively (P=0.002 by Fisher’s exact test).
Among patients undergoing coronary-artery surgery, tranexamic acid was associated with a lower risk of bleeding than was placebo, without a higher risk of death or thrombotic complications within 30 days after surgery. Tranexamic acid was associated with a higher risk of postoperative seizures. (Funded by the Australian National Health and Medical Research Council and others; ATACAS Australia New Zealand Clinical Trials Registry number, ACTRN12605000557639.)
Supported by grants from the Australian National Health and Medical Research Council (NHMRC, ID 334015 and 1009203); the Australian and New Zealand College of Anaesthetists; Monash University, Australia; and the National Institute of Health Research. Bayer Pharma provided the aspirin and matched placebo tablets used in the aspirin comparison. Drs. Myles and Cooper are each supported by an Australian NHMRC Practitioner’s Fellowship.
Disclosure forms provided by the authors are provided with the full text of this article at NEJM.org.
This article was published on October 23, 2016, at NEJM.org.
We thank Adam Meehan for data management, the construction of an electronic database accessible on the Web, and the provision of both a telephone-based voice recognition service and a Web-based service that allowed for patient randomization; and Profs. Andrew Tonkin and Henry Krum and all the members of the committees overseeing the trial, as well as the members of the Australian and New Zealand College of Anaesthetists Clinical Trials Network.
From the Alfred Hospital (P.S.M., D.J.C., S. Marasco, S.W.) and Monash University (P.S.M., J.A.S., A.F., D.J.C., S. Marasco, J.M., S.W.), Melbourne, VIC, St. Vincent’s Hospital, Fitzroy, VIC (B.S.), and the Royal Adelaide Hospital, Adelaide, SA (T.P.) — all in Australia; South West Cardiac Centre, Derriford Hospital, Plymouth, United Kingdom (M.J.); Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, Canada (J.S.B.); Auckland City Hospital, Auckland (S. McGuinness), and Waikato Hospital, Hamilton (K.B.) — both in New Zealand; the Chinese University of Hong Kong, Hong Kong (M.T.V.C.); and Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele and Vita-Salute San Raffaele University, Milan (G.L.).
A list of participating centers and investigators in the Aspirin and Tranexamic Acid for Coronary Artery Surgery (ATACAS) trial of the Australian and New Zealand College of Anaesthetists (ANZCA) Clinical Trials Network is provided in the Supplementary Appendix, available at NEJM.org.
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