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Tranexamic Acid in Patients Undergoing Noncardiac Surgery. / Devereaux, P. J.; Marcucci, Maura; Painter, Thomas W. et al.

In: New England Journal of Medicine, Vol. 386, No. 21, 26.05.2022, p. 1986-1997.

Research output: Contribution to journal › Article › peer-review

Harvard

Devereaux, PJ, Marcucci, M, Painter, TW, Conen, D, Lomivorotov, V, Sessler, DI, Chan, MTV, Borges, FK, Martínez-Zapata, MJ, Wang, CY, Xavier, D, Ofori, SN, Wang, MK, Efremov, S, Landoni, G, Kleinlugtenbelt, YV, Szczeklik, W, Schmartz, D, Garg, AX, Short, TG, Wittmann, M, Meyhoff, CS, Amir, M, Torres, D, Patel, A, Duceppe, E, Ruetzler, K, Parlow, JL, Tandon, V, Fleischmann, E, Polanczyk, CA, Lamy, A, Astrakov, SV, Rao, M, Wu, WKK, Bhatt, K, de Nadal, M, Likhvantsev, VV, Paniagua, P, Aguado, HJ, Whitlock, RP, McGillion, MH, Prystajecky, M, Vincent, J, Eikelboom, J, Copland, I, Balasubramanian, K, Turan, A, Bangdiwala, SI, Stillo, D, Gross, PL, Cafaro, T, Alfonsi, P, Roshanov, PS, Belley-Côté, EP, Spence, J, Richards, T, VanHelder, T, McIntyre, W, Guyatt, G, Yusuf, S & Leslie, K 2022, 'Tranexamic Acid in Patients Undergoing Noncardiac Surgery', New England Journal of Medicine, vol. 386, no. 21, pp. 1986-1997. https://doi.org/10.1056/NEJMoa2201171

APA

Devereaux, P. J., Marcucci, M., Painter, T. W., Conen, D., Lomivorotov, V., Sessler, D. I., Chan, M. T. V., Borges, F. K., Martínez-Zapata, M. J., Wang, C. Y., Xavier, D., Ofori, S. N., Wang, M. K., Efremov, S., Landoni, G., Kleinlugtenbelt, Y. V., Szczeklik, W., Schmartz, D., Garg, A. X., ... Leslie, K. (2022). Tranexamic Acid in Patients Undergoing Noncardiac Surgery. New England Journal of Medicine, 386(21), 1986-1997. https://doi.org/10.1056/NEJMoa2201171

Vancouver

Devereaux PJ, Marcucci M, Painter TW, Conen D, Lomivorotov V, Sessler DI et al. Tranexamic Acid in Patients Undergoing Noncardiac Surgery. New England Journal of Medicine. 2022 May 26;386(21):1986-1997. doi: 10.1056/NEJMoa2201171

Author

Devereaux, P. J. ; Marcucci, Maura ; Painter, Thomas W. et al. / Tranexamic Acid in Patients Undergoing Noncardiac Surgery. In: New England Journal of Medicine. 2022 ; Vol. 386, No. 21. pp. 1986-1997.

BibTeX

@article{b573aec355924c4eba4eff0ef6b9e095,
title = "Tranexamic Acid in Patients Undergoing Noncardiac Surgery",
abstract = "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.",
keywords = "Antifibrinolytic Agents/adverse effects, Canada, Hemorrhage/etiology, Humans, Surgical Procedures, Operative, Thrombosis/chemically induced, Tranexamic Acid/adverse effects",
author = "Devereaux, {P. J.} and Maura Marcucci and Painter, {Thomas W.} and David Conen and Vladimir Lomivorotov and Sessler, {Daniel I.} and Chan, {Matthew T.V.} and Borges, {Flavia K.} and Mart{\'i}nez-Zapata, {Mar{\'i}a J.} and Wang, {Chew Yin} and Denis Xavier and Ofori, {Sandra N.} and Wang, {Michael K.} and Sergey Efremov and Giovanni Landoni and Kleinlugtenbelt, {Ydo V.} and Wojciech Szczeklik and Denis Schmartz and Garg, {Amit X.} and Short, {Timothy G.} and Maria Wittmann and Meyhoff, {Christian S.} and Mohammed Amir and David Torres and Ameen Patel and Emmanuelle Duceppe and Kurt Ruetzler and Parlow, {Joel L.} and Vikas Tandon and Edith Fleischmann and Polanczyk, {Carisi A.} and Andre Lamy and Astrakov, {Sergey V.} and Mangala Rao and Wu, {William K.K.} and Keyur Bhatt and {de Nadal}, Miriam and Likhvantsev, {Valery V.} and Pilar Paniagua and Aguado, {Hector J.} and Whitlock, {Richard P.} and McGillion, {Michael H.} and Michael Prystajecky and Jessica Vincent and John Eikelboom and Ingrid Copland and Kumar Balasubramanian and Alparslan Turan and Bangdiwala, {Shrikant I.} and David Stillo and Gross, {Peter L.} and Teresa Cafaro and Pascal Alfonsi and Roshanov, {Pavel S.} and Belley-C{\^o}t{\'e}, {Emilie P.} and Jessica Spence and Toby Richards and Tomas VanHelder and William McIntyre and Gordon Guyatt and Salim Yusuf and Kate Leslie",
note = "Funding Information: Supported by a Foundation Grant (FDN-143302, to Dr. De-vereaux) from the Canadian Institutes of Health Research, a Project Grant (1162362) from the Australian National Health and Medical Research Council, and a grant from General Research Fund 14104419, Research Grant Council, Hong Kong, and by the Population Health Research Institute. Publisher Copyright: Copyright {\textcopyright} 2022 Massachusetts Medical Society.",
year = "2022",
month = may,
day = "26",
doi = "10.1056/NEJMoa2201171",
language = "English",
volume = "386",
pages = "1986--1997",
journal = "New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachusetts Medical Society",
number = "21",

}

RIS

TY - JOUR

T1 - Tranexamic Acid in Patients Undergoing Noncardiac Surgery

AU - Devereaux, P. J.

AU - Marcucci, Maura

AU - Painter, Thomas W.

AU - Conen, David

AU - Lomivorotov, Vladimir

AU - Sessler, Daniel I.

AU - Chan, Matthew T.V.

AU - Borges, Flavia K.

AU - Martínez-Zapata, María J.

AU - Wang, Chew Yin

AU - Xavier, Denis

AU - Ofori, Sandra N.

AU - Wang, Michael K.

AU - Efremov, Sergey

AU - Landoni, Giovanni

AU - Kleinlugtenbelt, Ydo V.

AU - Szczeklik, Wojciech

AU - Schmartz, Denis

AU - Garg, Amit X.

AU - Short, Timothy G.

AU - Wittmann, Maria

AU - Meyhoff, Christian S.

AU - Amir, Mohammed

AU - Torres, David

AU - Patel, Ameen

AU - Duceppe, Emmanuelle

AU - Ruetzler, Kurt

AU - Parlow, Joel L.

AU - Tandon, Vikas

AU - Fleischmann, Edith

AU - Polanczyk, Carisi A.

AU - Lamy, Andre

AU - Astrakov, Sergey V.

AU - Rao, Mangala

AU - Wu, William K.K.

AU - Bhatt, Keyur

AU - de Nadal, Miriam

AU - Likhvantsev, Valery V.

AU - Paniagua, Pilar

AU - Aguado, Hector J.

AU - Whitlock, Richard P.

AU - McGillion, Michael H.

AU - Prystajecky, Michael

AU - Vincent, Jessica

AU - Eikelboom, John

AU - Copland, Ingrid

AU - Balasubramanian, Kumar

AU - Turan, Alparslan

AU - Bangdiwala, Shrikant I.

AU - Stillo, David

AU - Gross, Peter L.

AU - Cafaro, Teresa

AU - Alfonsi, Pascal

AU - Roshanov, Pavel S.

AU - Belley-Côté, Emilie P.

AU - Spence, Jessica

AU - Richards, Toby

AU - VanHelder, Tomas

AU - McIntyre, William

AU - Guyatt, Gordon

AU - Yusuf, Salim

AU - Leslie, Kate

N1 - Funding Information: Supported by a Foundation Grant (FDN-143302, to Dr. De-vereaux) from the Canadian Institutes of Health Research, a Project Grant (1162362) from the Australian National Health and Medical Research Council, and a grant from General Research Fund 14104419, Research Grant Council, Hong Kong, and by the Population Health Research Institute. Publisher Copyright: Copyright © 2022 Massachusetts Medical Society.

PY - 2022/5/26

Y1 - 2022/5/26

N2 - 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.

AB - 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.

KW - Antifibrinolytic Agents/adverse effects

KW - Canada

KW - Hemorrhage/etiology

KW - Humans

KW - Surgical Procedures, Operative

KW - Thrombosis/chemically induced

KW - Tranexamic Acid/adverse effects

UR - http://www.scopus.com/inward/record.url?scp=85128013076&partnerID=8YFLogxK

UR - https://www.mendeley.com/catalogue/99420fef-c6e2-36ab-881d-94aefdd2fc13/

U2 - 10.1056/NEJMoa2201171

DO - 10.1056/NEJMoa2201171

M3 - Article

C2 - 35363452

AN - SCOPUS:85128013076

VL - 386

SP - 1986

EP - 1997

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 21

ER -

ID: 36438436