Aspirin in patients undergoing noncardiac surgery.
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Devereaux P J, Mrkobrada Marko, Sessler Daniel I, Leslie Kate, Alonso-Coello Pablo, Kurz Andrea, Villar Juan Carlos, Sigamani Alben, Biccard Bruce M, Meyhoff Christian S, Parlow Joel L, Guyatt Gordon, Robinson Andrea, Garg Amit X, Rodseth Reitze N, Botto Fernando, Lurati Buse Giovanna, Xavier Denis, Chan Matthew T V, Tiboni Maria, Cook Deborah, Kumar Priya A, Forget Patrice, Malaga German, Fleischmann Edith, Amir Mohammed, Eikelboom John, Mizera Richard, Torres David, Wang C Y, VanHelder Tomas, Paniagua Pilar, Berwanger Otavio, Srinathan Sadeesh, Graham Michelle, Pasin Laura, Le Manach Yannick, Gao Peggy, Pogue Janice, Whitlock Richard, Lamy André, Kearon Clive, Baigent Colin, Chow Clara, Pettit Shirley, Chrolavicius Susan, Yusuf Salim, POISE-2 Investigators
Аннотация
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.).