title: Tranexamic Acid in Patients Undergoing Coronary-Artery Surgery.
abstract: 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 .).
authors: 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.).
authors: Paul S
authors: PS
authors: Myles
authors: 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.).
authors: Julian A
authors: JA
authors: Smith
authors: 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.).
authors: Andrew
authors: A
authors: Forbes
authors: 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.).
authors: Brendan
authors: B
authors: Silbert
authors: 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.).
authors: Mohandas
authors: M
authors: Jayarajah
authors: 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.).
authors: Thomas
authors: T
authors: Painter
authors: 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.).
authors: D James
authors: DJ
authors: Cooper
authors: 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.).
authors: Silvana
authors: S
authors: Marasco
authors: 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.).
authors: John
authors: J
authors: McNeil
authors: 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.).
authors: Jean S
authors: JS
authors: Bussières
authors: 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.).
authors: Shay
authors: S
authors: McGuinness
authors: 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.).
authors: Kelly
authors: K
authors: Byrne
authors: 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.).
authors: Matthew T V
authors: MT
authors: Chan
authors: 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.).
authors: Giovanni
authors: G
authors: Landoni
authors: 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.).
authors: Sophie
authors: S
authors: Wallace
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000933:Antifibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001241:Aspirin / Q000627:therapeutic use; D001803:Blood Transfusion / Q000706:statistics & numerical data; D001026:Coronary Artery Bypass; D003324:Coronary Artery Disease / Q000401:mortality / Q000601:surgery; D004311:Double-Blind Method; D005260:Female; D006351:Heart Valves / Q000601:surgery; D006470:Hemorrhage / Q000139:chemically induced / Q000517:prevention & control*; D006801:Humans; D007431:Intraoperative Complications / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011183:Postoperative Complications / Q000139:chemically induced; D012086:Reoperation / Q000706:statistics & numerical data; D012640:Seizures / Q000139:chemically induced; D013927:Thrombosis / Q000139:chemically induced; D014148:Tranexamic Acid / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000933:Antifibrinolytic Agents; D010975:Platelet Aggregation Inhibitors; D014148:Tranexamic Acid; D001241:Aspirin