Tranexamic acid in patients undergoing noncardiac surgery

Devereaux, P. J. and Marcucci, M. and Painter, T. W. and Conen, D. and Lomivorotov, V and Sessler, D. and Chan, M. T. and Borges, F. K. and Martinez-Zapata, M. J. and Wang, Chew Yin and Xavier, D. and Ofori, S. N. and Wang, M. K. and Efremov, S. and Landoni, G. and Kleinlugtenbelt, Y. and Szczeklik, W. and Schmartz, D. and Garg, A. X. and Short, T. G. and Wittmann, M. and Meyhoff, C. S. and Amir, M. and Torres, D. and Patel, A. and Duceppe, E. and Ruetzler, K. and Parlow, J. L. and Tandon, V and Fleischmann, E. and Polanczyk, C. A. and Lamy, A. and Astrakov, S. and Rao, M. and Wu, W. K. K. and Bhatt, K. and de Nadal, M. and Likhvantsev, V. V. and Paniagua, P. and Aguado, H. J. and Whitlock, R. P. and McGillion, M. H. and Prystajecky, M. and Vincent, J. and Eikelboom, J. and Copland, I and Balasubramanian, K. and Turan, A. and Bangdiwala, S. and Stillo, D. and Gross, P. L. and Cafaro, T. and Alfonsi, P. and Roshanov, P. S. and Belley-Cote, E. P. and Spence, J. and Richards, T. and VanHelder, T. and McIntyre, W. and Guyatt, G. and Yusuf, S. and Leslie, K. and Investigators, POISE-3 (2022) Tranexamic acid in patients undergoing noncardiac surgery. The New England Journal of Medicine, 386 (21). pp. 1986-1997. ISSN 0028-4793, DOI

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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). Conslusions: 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.

Item Type: Article
Funders: Canadian Institutes of Health Research (CIHR) (Grant No. FDN-143302), National Health and Medical Research Council (NHMRC) of Australia (Grant No. 14104419), General Research Fund, Hong Kong Research Grants Council, Population Health Research Institute
Uncontrolled Keywords: Blood-transfusion; Hemorrhage; Mortality; Bims
Subjects: R Medicine
Divisions: Faculty of Medicine > Anaesthesiology Department
Depositing User: Ms. Juhaida Abd Rahim
Date Deposited: 19 Oct 2023 08:14
Last Modified: 20 Oct 2023 01:47

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