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N Engl J Med. 2014 Apr 17;370(16):1494-503. doi: 10.1056/NEJMoa1401105. Epub 2014 Mar 31.

Aspirin in patients undergoing noncardiac surgery.

Collaborators (338)

DeBeer J, Mizera R, Patel A, VanHelder T, Cook D, Dechert W, Jackson P, Tiboni M, Allard R, Dumerton-Shore D, McCourt J, Parlow JL, Jones PM, Lavi R, Lavi S, Moor R, Dresser GK, Garg AX, Gros ML, Schumann VC, Baur M, MacDonald C, Wirzba B, Regalado O, Srinathan SK, Ong DD, Todd A, Abbas S, Beattie WS, Chan VW, Chin KJ, Wijeysundera DN, Graham MM, Irwin M, Jacka M, El Beheiry H, McMullen SM, MacDonald P, Akhtar Z, Ayad S, Buttar M, Deroee A, Eshraghi Y, Fergany A, Finnigan P, Fu A, Grady M, Helper S, Hesler B, Honar H, Hutcherson M, Krebs V, Kurz A, Lee J, Malik M, Podolyak A, Salmasi V, Sessler DI, Arora H, Coombs RF, Kumar PA, Martinelli SM, Bergese SD, Melibary SB, Uribe AA, Jordan M, Miller SA, Cata JP, Nemergut EC, Candiotti KA, Memtsoudis SG, McKay RE, Montes FR, Parra GA, Rojas MF, Plata R, Vásquez SM, Sarquis T, Haider Z, Jane NB, Lanjewar PP, Rahate PV, Mehra BR, Premendaran B, Abraham V, George P, Kumar P, Gaikwad SB, Mohan NV, Sidhu G, Alvarez J, Gonzalez R, Maestre M, Popova E, Urrutia G, de Nadal M, González-Suárez S, González-Tallada A, Plou P, Mena E, Riveira C, del Valle S, Tena B, Lang SA, Ludbrook GL, Painter TW, Terblanche NC, Osborne C, Mahood JR, Leslie K, Myles PS, Sivalingam P, Riedel B, Elhalawani I, Biccard BM, Drummond L, Mugabi A, Naidoo P, Myburgh AL, Porrill OS, Diedericks BJ, Turton EW, Bøgeskov M, Dahl RM, Madsen MV, Søndergaard ES, Bauer NE, Martinsen KR, Chan MT, Choi GY, Gin T, Ng SS, Bidgoli SJ, Van der Linden PJ, De Kock M, Forget P, Fleischmann E, Kabon B, Luf F, Radonic M, Amir M, Ishtiaq O, Safdar J, Acuna-Villaorduna A, Barrionuevo P, Castaneda-Guarderas A, Caballero JA, Lau VE, Aphang-Lam MR, Lembo R, Pasin L, Gossetti B, Jara X, Leon P, Torres D, Ong GS, Wang CY, Lee HS, Seeberger EE, Seeberger MD, Alfonsi P, Coriat P, Piriou V, Vizcaychipi MP, Rech RL, Bergo RR, Walker S, Devereaux PJ, Sessler DI, Kurz A, Mrkobrada M, Lurati Buse G, Botto F, Rodseth R, Robinson A, Guyatt G, LeManach Y, Pogue J, Pettit S, Chrolavicius S, Yusuf S, Botto F, Díaz R, Leslie K, Fleischmann E, Forget P, Berwanger O, Devereaux PJ, Mrkobrada M, Torres D, Villar JC, Cortés OL, Meyhoff CS, Wetterslev J, Alfonsi P, Hoeft A, Wittmann M, Chan M, Sigamani A, Xavier D, Landoni G, Wang CY, Ishtiaq O, Malaga G, Biccard BM, Alonso-Coello P, Conen D, Balaji P, Kurz A, Robinson A, Sovereign T, Blake L, Sephton J, Serra A, Agrippa C, Lawrence M, Gao P, Pettit S, Chrolavicius S, Leslie K, Alonso-Coello P, Biccard B, Chan M, Meyhoff CS, Villar JC, Xavier D, Wang CY, Landoni G, Berwanger O, Jacka M, Malaga G, Chow C, Gluud C, Baigent C, Karthikeyan G, Devereaux PJ, Alfonsi P, Alonso-Coello P, Auerbach A, Baigent C, Balaji P, Beattie S, Berwanger O, Biccard BM, Botto F, Buckley N, Chan M, Chow C, Chrolavicius S, Conen D, Cook D, Douketis J, Eikelboom J, Forget P, Garg AX, Gerstein H, Ghali W, Graham M, Guyatt G, Hart R, Hill M, Hoeft A, Jacka M, Karthikeyan G, Kearon C, Kurz A, Lamy A, Landoni G, LeManach Y, Leslie K, Lurati Buse G, Malaga G, McAlister F, McAuley D, Meyhoff CS, Miller S, Mrkobrada M, O'Donnell M, Pais P, Parlow J, Pogue J, Robinson A, Rodseth R, Schricker T, Sessler D, Simunovic M, Srinathan S, Teoh K, Torres D, Urrutia G, Villar JC, Walsh M, Wang CY, Wetterslev J, Whitlock R, Wijeysundera D, Xavier D, Yang H, Yusuf S, Guyatt G, Botto F, Alonso-Coello P, Alshalash S, Alvarez J, Bessissow A, Douketis J, Duceppe E, Fleischmann E, Hart R, Hill M, Khalid Z, Khan J, Kurz A, Lauw M, Le Manach Y, Lurati Buse G, Martinsen K, Meyhoff CS, Mrkobrada M, Neary J, Oczkowski W, O'Donnell M, Paniagua P, Papina M, Pasin L, Popova E, Rodseth R, Seeberger M, Tandon V, Thomas S, Tiboni M, Torres D, Wetterslev J, Friedman L, Cheng D, Johnstone D, Lowenstein E, Roberts R.

Author information

1
The authors' affiliations are listed in the Appendix.

Abstract

BACKGROUND:

There is substantial variability in the perioperative administration of aspirin in patients undergoing noncardiac surgery, both among patients who are already on an aspirin regimen and among those who are not.

METHODS:

Using a 2-by-2 factorial trial design, we randomly assigned 10,010 patients who were preparing to undergo noncardiac surgery and were at risk for vascular complications to receive aspirin or placebo and clonidine or placebo. The results of the aspirin trial are reported here. The patients were stratified according to whether they had not been taking aspirin before the study (initiation stratum, with 5628 patients) or they were already on an aspirin regimen (continuation stratum, with 4382 patients). Patients started taking aspirin (at a dose of 200 mg) or placebo just before surgery and continued it daily (at a dose of 100 mg) for 30 days in the initiation stratum and for 7 days in the continuation stratum, after which patients resumed their regular aspirin regimen. The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days.

RESULTS:

The primary outcome occurred in 351 of 4998 patients (7.0%) in the aspirin group and in 355 of 5012 patients (7.1%) in the placebo group (hazard ratio in the aspirin group, 0.99; 95% confidence interval [CI], 0.86 to 1.15; P=0.92). Major bleeding was more common in the aspirin group than in the placebo group (230 patients [4.6%] vs. 188 patients [3.8%]; hazard ratio, 1.23; 95% CI, 1.01, to 1.49; P=0.04). The primary and secondary outcome results were similar in the two aspirin strata.

CONCLUSIONS:

Administration of aspirin before surgery and throughout the early postsurgical period had no significant effect on the rate of a composite of death or nonfatal myocardial infarction but increased the risk of major bleeding. (Funded by the Canadian Institutes of Health Research and others; POISE-2 ClinicalTrials.gov number, NCT01082874.).

PMID:
24679062
DOI:
10.1056/NEJMoa1401105
[Indexed for MEDLINE]
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