Tranexamic Acid in Patients Undergoing Noncardiac Surgery.
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
26 05 2022
26 05 2022
Historique:
pubmed:
2
4
2022
medline:
28
5
2022
entrez:
1
4
2022
Statut:
ppublish
Résumé
Perioperative bleeding is common in patients undergoing noncardiac surgery. Tranexamic acid is an antifibrinolytic drug that may safely decrease such bleeding. 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. 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). 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.).
Sections du résumé
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.).
Identifiants
pubmed: 35363452
doi: 10.1056/NEJMoa2201171
doi:
Substances chimiques
Antifibrinolytic Agents
0
Tranexamic Acid
6T84R30KC1
Banques de données
ClinicalTrials.gov
['NCT03505723']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1986-1997Subventions
Organisme : Medical Research Council
ID : MR/M009211/1
Pays : United Kingdom
Organisme : National Health and Medical Research Council
ID : Project Grant 1162362
Organisme : CIHR
ID : FDN-143302
Pays : Canada
Investigateurs
P J Devereaux
(PJ)
Shrikant I Bangdiwala
(SI)
Flavia K Borges
(FK)
David Conen
(D)
Ingrid Copland
(I)
Gordon Guyatt
(G)
Maura Marcucci
(M)
Daniel I Sessler
(DI)
Jessica Vincent
(J)
Bruce M Biccard
(BM)
Matthew T V Chan
(MTV)
John Eikelboom
(J)
Kate Leslie
(K)
Vladimir Lomivorotov
(V)
Christian S Meyhoff
(CS)
Thomas Painter
(T)
Joel Parlow
(J)
Toby Richards
(T)
Wojciech Szczeklik
(W)
Vikas Tandon
(V)
Denis Xavier
(D)
Pascal Alfonsi
(P)
Mohammed Amir
(M)
Shrikant Bangdiwala
(S)
Emmanuelle Duceppe
(E)
Edith Fleischmann
(E)
Peter Gross
(P)
Raja Jayaram
(R)
Ydo V Kleinlugtenbelt
(YV)
Andrea Kurz
(A)
Giovanni Landoni
(G)
Maria José Martinez Zapata
(MJ)
Yannick Lemanach
(Y)
Michael McGillion
(M)
Carisi Polanczyk
(C)
Pavel Roshanov
(P)
Denis Schmartz
(D)
Tim Short
(T)
Sadeesh Srinathan
(S)
David Torres
(D)
Chew Yin Wang
(CY)
Dale Williams
(D)
Maria Wittmann
(M)
Salim Yusuf
(S)
Michael Ke Wang
(MK)
Sandra Ofori
(S)
Teresa Cafaro
(T)
Michael R Prystajecky
(MR)
Mikhail Ya Yadgarov
(MY)
Dmitry B Borisov
(DB)
John Gorman
(J)
Stefano Italiano
(S)
Andrés Valenzuela Suárez
(A)
Steffen Blum
(S)
Nuria Ruiz-López
(N)
Christian E Haarmark Nielssen
(CE)
Anna Włudarczyk
(A)
Federico Germini
(F)
Javiera Paz Vasquez
(JP)
L J Bleijerveen
(LJ)
Adrià Font
(A)
Stefan Schandelmaier
(S)
Jesse Popov
(J)
Daniel Moller
(D)
Jessica Spence
(J)
Carlos Moliner Abós
(C)
Denis Losik
(D)
Arnav Agarwal
(A)
Emilie Belley-Côté
(E)
Chantal Mulkens
(C)
Elizaveta Fisher
(E)
Pawel Wrona
(P)
Martin Sramek
(M)
Steffan F Stella
(SF)
Antonia Nucera
(A)
Franziska Kuestermann
(F)
Emmanuel Egom
(E)
Shaan Gupta
(S)
Luis Morillo
(L)
Alexander Thiel
(A)
Ian Roberts
(I)
Dean Fergusson
(D)
Pierre Foëx
(P)
Finlay McAlister
(F)
Sara Di Diodato
(S)
Rosemary Howe
(R)
Hannah MacDonald
(H)
Louise Mastrangelo
(L)
Clare McGall
(C)
Natalie Mercuri
(N)
Sarah Molnar
(S)
David Stillo
(D)
Trisha Southall
(T)
Jennifer Swanson
(J)
Makayla Tosh
(M)
Kumar Balasubramanian
(K)
Eric Deng
(E)
Tamara Marsden
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Mark Molec
(M)
Olga Shestakovska
(O)
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Ydo Kleinlugtenbelt
(Y)
Chaoran Wu
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Simon Macklin
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Palvannan Sivalingam
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