Devereaux P J, Marcucci Maura, Painter Thomas W, Conen David, Lomivorotov Vladimir, Sessler Daniel I, Chan Matthew T V, Borges Flavia K, Martínez-Zapata María J, Wang Chew Yin, Xavier Denis, Ofori Sandra N, Wang Michael K, Efremov Sergey, Landoni Giovanni, Kleinlugtenbelt Ydo V, Szczeklik Wojciech, Schmartz Denis, Garg Amit X, Short Timothy G, Wittmann Maria, Meyhoff Christian S, Amir Mohammed, Torres David, Patel Ameen, Duceppe Emmanuelle, Ruetzler Kurt, Parlow Joel L, Tandon Vikas, Fleischmann Edith, Polanczyk Carisi A, Lamy Andre, Astrakov Sergey V, Rao Mangala, Wu William K K, Bhatt Keyur, de Nadal Miriam, Likhvantsev Valery V, Paniagua Pilar, Aguado Hector J, Whitlock Richard P, McGillion Michael H, Prystajecky Michael, Vincent Jessica, Eikelboom John, Copland Ingrid, Balasubramanian Kumar, Turan Alparslan, Bangdiwala Shrikant I, Stillo David, Gross Peter L, Cafaro Teresa, Alfonsi Pascal, Roshanov Pavel S, Belley-Côté Emilie P, Spence Jessica, Richards Toby, VanHelder Tomas, McIntyre William, Guyatt Gordon, Yusuf Salim, Leslie Kate
From the Population Health Research Institute (P.J.D., M.M., D.C., F.K.B., S.N.O., M.K.W., A.L., R.P.W., M.H.M., J.V., J.E., I.C., K. Balasubramanian, S.I.B., D. Stillo, T.C., P.S.R., E.P.B.-C., J.S., W.M., S.Y.), the Departments of Health Research Methods, Evidence, and Impact (P.J.D., M.M., D.C., F.K.B., S.N.O., M.K.W., A.X.G., S.I.B., J.S., G.G.), Medicine (P.J.D., M.M., D.C., F.K.B., M.K.W., A.P., V.T., J.E., P.L.G., E.P.B.-C., W.M., G.G., S.Y.), Surgery (A.L., R.P.W.), and Anesthesia (J.S., T.V.) and the School of Nursing (M.H.M.), McMaster University, Hamilton, the Departments of Medicine (A.X.G., P.S.R.) and Epidemiology and Biostatistics (A.X.G.), Western University, London, and the Department of Anesthesiology and Perioperative Medicine, Queen's University and Kingston Health Sciences Centre, Kingston (J.L.P.), ON, the Department of Medicine, Centre Hospitalier de l'Université de Montréal (E.D.), and the Department of Medicine, Jewish General Hospital, McGill University (T.C.), Montreal, and the Department of Medicine, University of Saskatchewan, Saskatoon (M.P.) - all in Canada; the Discipline of Acute Care Medicine, University of Adelaide (T.W.P.), and the Department of Anaesthesia, Royal Adelaide Hospital (T.W.P.), Adelaide, SA, and the Department of Anaesthesia and Perioperative Medicine, Monash University (T.R.), and the Department of Critical Care Medicine, Melbourne Medical School, University of Melbourne (K.L.), Melbourne, VIC - all in Australia; the Department of Anesthesiology and Intensive Care, E. Meshalkin National Medical Research Center (V.L.), and the Department of Anesthesiology and Intensive Care (V.L.) and the Department of Anesthesiology, V. Zelman Institute of Medicine and Psychology (S.V.A.), Novosibirsk State University, Novosibirsk, Saint Petersburg State University Hospital, Saint Petersburg (S.E.), and V. Negovsky Reanimatology Research Institute, Anesthesia and Intensive Care Department, First Moscow State Medical University (Sechenov University), Moscow (V.V.L.) - all in Russia; the Departments of Outcomes Research (D.I.S., K.R., A.T.) and General Anesthesia (K.R., A.T.) and the Anesthesiology Institute (D.I.S., K.R., A.T.), Cleveland Clinic, Cleveland; Chinese University of Hong Kong, Shatin, China (M.T.V.C., W.K.K.W.); Iberoamerican Cochrane Center, Public Health and Clinical Epidemiology Service, Institut d'Investigació Biomèdica Sant Pau, Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (M.J.M.-Z.), the Department of Anesthesiology and Intensive Care, Hospital Vall d'Hebron, Universitat Autònoma de Barcelona (M.N.), and the Anesthesiology Department, Santa Creu i Sant Pau University Hospital (P.P.), Barcelona, and the Trauma and Orthopedic Surgery Department, Hospital Clínico Universitario de Valladolid, Valladolid (H.J.A.) - all in Spain; the Department of Anesthesiology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia (C.Y.W.); St. John's Medical College, Bangalore (D.X., M.R.), and the Department of Gastrointestinal Surgery, Surat Institute of Digestive Sciences Hospital and Research Center, Surat (K. Bhatt) - both in India; the Department of Anesthesiology and Intensive Care, IRCCS San Raffaele Scientific Institute, Vita Salute San Raffaele University, Milan (G.L.); the Department of Orthopedic and Trauma Surgery, Deventer Ziekenhuis, Deventer, the Netherlands (Y.V.K.); Jagiellonian University Medical College, Center for Intensive Care and Perioperative Medicine, Krakow, Poland (W.S.); Centre Hospitalier Universitaire Brugmann, Université Libre de Bruxelles, Brussels (D. Schmartz); the Department of Anesthesia, Auckland City Hospital, and the School of Health Sciences, University of Auckland, Auckland, New Zealand (T.G.S.); the Department of Anesthesiology and Intensive Care Medicine, University Hospital Bonn, Bonn, Germany (M.W.); the Department of Anesthesia and Intensive Care, Copenhagen University Hospital-Bispebjerg and Frederiksberg, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen (C.S.M.); Shifa International Hospital, Islamabad, Pakistan (M.A.); Departamento de Epidemiología y Estudios en Salud, Universidad de Los Andes, and Servicio de Anestesiología, Clínica Santa María, Santiago, Chile (D.T.); the Department of Anesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna (E.F.); Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, National Institute for Health Technology Assessment, and Hospital Moinhos de Vento, Porto Alegre, Brazil (C.A.P.); and the Department of Anesthesia, Hospital Paris Saint Joseph, University of Paris, Paris (P.A.).
N Engl J Med. 2022 May 26;386(21):1986-1997. doi: 10.1056/NEJMoa2201171. Epub 2022 Apr 2.
BACKGROUND: Perioperative bleeding is common in patients undergoing noncardiac surgery. Tranexamic acid is an antifibrinolytic drug that may safely decrease such bleeding. METHODS: We conducted a trial involving patients undergoing noncardiac surgery. Patients were randomly assigned to receive tranexamic acid (1-g intravenous bolus) or placebo at the start and end of surgery (reported here) and, with the use of a partial factorial design, a hypotension-avoidance or hypertension-avoidance strategy (not reported here). The primary efficacy outcome was life-threatening bleeding, major bleeding, or bleeding into a critical organ (composite bleeding outcome) at 30 days. The primary safety outcome was myocardial injury after noncardiac surgery, nonhemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism (composite cardiovascular outcome) at 30 days. To establish the noninferiority of tranexamic acid to placebo for the composite cardiovascular outcome, the upper boundary of the one-sided 97.5% confidence interval for the hazard ratio had to be below 1.125, and the one-sided P value had to be less than 0.025. RESULTS: A total of 9535 patients underwent randomization. A composite bleeding outcome event occurred in 433 of 4757 patients (9.1%) in the tranexamic acid group and in 561 of 4778 patients (11.7%) in the placebo group (hazard ratio, 0.76; 95% confidence interval [CI], 0.67 to 0.87; absolute difference, -2.6 percentage points; 95% CI, -3.8 to -1.4; two-sided P<0.001 for superiority). A composite cardiovascular outcome event occurred in 649 of 4581 patients (14.2%) in the tranexamic acid group and in 639 of 4601 patients (13.9%) in the placebo group (hazard ratio, 1.02; 95% CI, 0.92 to 1.14; upper boundary of the one-sided 97.5% CI, 1.14; absolute difference, 0.3 percentage points; 95% CI, -1.1 to 1.7; one-sided P = 0.04 for noninferiority). CONCLUSIONS: Among patients undergoing noncardiac surgery, the incidence of the composite bleeding outcome was significantly lower with tranexamic acid than with placebo. Although the between-group difference in the composite cardiovascular outcome was small, the noninferiority of tranexamic acid was not established. (Funded by the Canadian Institutes of Health Research and others; POISE-3 ClinicalTrials.gov number, NCT03505723.).
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