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Published on: January 19, 2024
Tranexamic Acid in Patients Undergoing Noncardiac Surgery
P J Devereaux1, Maura Marcucci1, Thomas W Painter1
1From 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.).
Tranexamic acid significantly reduced bleeding in noncardiac surgery patients. However, the study did not establish its noninferiority for preventing cardiovascular events, indicating a need for further research.
Area of Science:
- Anesthesiology
- Cardiovascular Medicine
- Hematology
Background:
- Perioperative bleeding is a frequent complication in noncardiac surgery.
- Tranexamic acid, an antifibrinolytic agent, is investigated for its potential to mitigate surgical bleeding.
- Patient safety and efficacy in surgical contexts are critical research areas.
Purpose of the Study:
- To evaluate the efficacy of tranexamic acid in reducing bleeding during noncardiac surgery.
- To assess the safety of tranexamic acid by examining its impact on cardiovascular outcomes.
- To determine the noninferiority of tranexamic acid compared to placebo for composite cardiovascular outcomes.
Main Methods:
- A randomized trial involving 9535 patients undergoing noncardiac surgery.
- Patients received either tranexamic acid (1-g IV bolus) or a placebo at the start and end of surgery.
- Primary outcomes included a composite bleeding event and a composite cardiovascular event within 30 days.
Main Results:
- Tranexamic acid significantly reduced the composite bleeding outcome (9.1% vs. 11.7%, P<0.001).
- The composite cardiovascular outcome occurred in 14.2% of the tranexamic acid group and 13.9% of the placebo group (HR, 1.02; 95% CI, 0.92 to 1.14).
- Noninferiority for the composite cardiovascular outcome was not established (one-sided P=0.04).
Conclusions:
- Tranexamic acid effectively lowers the incidence of bleeding in patients undergoing noncardiac surgery.
- While the cardiovascular event difference was small, tranexamic acid's noninferiority for these outcomes was not demonstrated.
- Further investigation is warranted regarding the cardiovascular safety profile of tranexamic acid in this patient population.
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