Tranexamic Acid in Patients Undergoing Noncardiac Surgery

P J Devereaux, Maura Marcucci, Thomas W Painter, David Conen, Vladimir Lomivorotov, Daniel I Sessler, Matthew T V Chan, Flavia K Borges, María J Martínez-Zapata, Chew-Yin Wang, Denis Xavier, Sandra N Ofori, Michael K Wang, Sergey Efremov, Giovanni Landoni, Ydo V Kleinlugtenbelt, Wojciech Szczeklik, Denis Schmartz, Amit X Garg, Timothy G ShortMaria Wittmann, Christian S Meyhoff, Mohammed Amir, David Torres, Ameen Patel, Emmanuelle Duceppe, Kurt Ruetzler, Joel L Parlow, Vikas Tandon, Edith Fleischmann, Carisi A Polanczyk, Andre Lamy, Sergey V Astrakov, Mangala Rao, William K K Wu, Keyur Bhatt, Miriam de Nadal, Valery V Likhvantsev, Pilar Paniagua, Hector J Aguado, Richard P Whitlock, Michael H McGillion, Michael Prystajecky, Jessica Vincent, John Eikelboom, Ingrid Copland, Kumar Balasubramanian, Alparslan Turan, Shrikant I Bangdiwala, David Stillo, POISE-3 Investigators, Marlene Søgaard (Medlem af forfattergruppering), Ossian Gundel (Medlem af forfattergruppering), Viktor Moseholm (Medlem af forfattergruppering), Diana B. Jensen (Medlem af forfattergruppering), Mia K Hansen (Medlem af forfattergruppering), Grethe Bendixen (Medlem af forfattergruppering), Anne Sofie Jensen (Medlem af forfattergruppering), Sanne Dahl Thorsager Olesen (Medlem af forfattergruppering), Naomi Nadler (Medlem af forfattergruppering), Mette Krogh Østerby (Medlem af forfattergruppering), Mojgan Vazin Kjeldsen (Medlem af forfattergruppering), Jawad Ahmad Zahid (Medlem af forfattergruppering), Nessn Azawi (Medlem af forfattergruppering), Ismail Gögenur (Medlem af forfattergruppering), Eske Kvanner Aasvang (Medlem af forfattergruppering), Niels Brandt Højlund-Hansen (Medlem af forfattergruppering), Theis Simon Bak (Medlem af forfattergruppering), Thomas Kistorp (Medlem af forfattergruppering), Martin Andreas Røder (Medlem af forfattergruppering)

Abstract

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.).

OriginalsprogEngelsk
TidsskriftThe New England journal of medicine
Vol/bind386
Udgave nummer21
Sider (fra-til)1986-1997
Antal sider12
ISSN0028-4793
DOI
StatusUdgivet - 26 maj 2022

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