Clonidine in patients undergoing noncardiac surgery.
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Devereaux P J, Sessler Daniel I, Leslie Kate, Kurz Andrea, Mrkobrada Marko, Alonso-Coello Pablo, 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, Chow Clara, Pettit Shirley, Chrolavicius Susan, Yusuf Salim, POISE-2 Investigators
Аннотация
METHODS: We performed a blinded, randomized trial with a 2-by-2 factorial design to allow separate evaluation of low-dose clonidine versus placebo and low-dose aspirin versus placebo in patients with, or at risk for, atherosclerotic disease who were undergoing noncardiac surgery. A total of 10,010 patients at 135 centers in 23 countries were enrolled. For the comparison of clonidine with placebo, patients were randomly assigned to receive clonidine (0.2 mg per day) or placebo just before surgery, with the study drug continued until 72 hours after surgery. The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days.
RESULTS: Clonidine, as compared with placebo, did not reduce the number of primary-outcome events (367 and 339, respectively; hazard ratio with clonidine, 1.08; 95% confidence interval [CI], 0.93 to 1.26; P=0.29). Myocardial infarction occurred in 329 patients (6.6%) assigned to clonidine and in 295 patients (5.9%) assigned to placebo (hazard ratio, 1.11; 95% CI, 0.95 to 1.30; P=0.18). Significantly more patients in the clonidine group than in the placebo group had clinically important hypotension (2385 patients [47.6%] vs. 1854 patients [37.1%]; hazard ratio 1.32; 95% CI, 1.24 to 1.40; P<0.001). Clonidine, as compared with placebo, was associated with an increased rate of nonfatal cardiac arrest (0.3% [16 patients] vs. 0.1% [5 patients]; hazard ratio, 3.20; 95% CI, 1.17 to 8.73; P=0.02).
CONCLUSIONS: Administration of low-dose clonidine in patients undergoing noncardiac surgery did not reduce the rate of the composite outcome of death or nonfatal myocardial infarction; it did, however, increase the risk of clinically important hypotension and nonfatal cardiac arrest. (Funded by the Canadian Institutes of Health Research and others; POISE-2 ClinicalTrials.gov number, NCT01082874.).