Tranexamic Acid in Patients Undergoing Noncardiac Surgery

Tsan, Samuel Ern Hung and Devereaux, P. J. and Marcucci, Maura and Painter, Thomas W. and Conen, David and Lomivorotov, Vladimir and Sessler, Daniel I and T.V. Chan, Matthew and Borges, Flavia K and Martínez-Zapata, María J. and Wang, Chew-Yin and Xavier, Denis and Ofori, Sandra N. (2022) Tranexamic Acid in Patients Undergoing Noncardiac Surgery. New England Journal of Medicine. pp. 1-12. ISSN 1533-4406

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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). 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 number, NCT03505723.)

Item Type: Article
Uncontrolled Keywords: noncardiac surgery, Tranexamic acid, antifibrinolytic drug, Perioperative bleeding.
Subjects: R Medicine > R Medicine (General)
R Medicine > RD Surgery
Divisions: Academic Faculties, Institutes and Centres > Faculty of Medicine and Health Sciences
Depositing User: Ern Hung
Date Deposited: 27 Apr 2022 00:24
Last Modified: 27 Apr 2022 00:30

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