-
Randomized Controlled Trial Multicenter Study
Aspirin in Patients With Previous Percutaneous Coronary Intervention Undergoing Noncardiac Surgery.
- Michelle M Graham, Daniel I Sessler, Joel L Parlow, Bruce M Biccard, Gordon Guyatt, Kate Leslie, Chan Matthew T V MTV The Chinese University of Hong Kong, Hong Kong, China (M.T.C.)., Christian S Meyhoff, Denis Xavier, Alben Sigamani, Priya A Kumar, Marko Mrkobrada, Deborah J Cook, Vikas Tandon, Jesus Alvarez-Garcia, Juan Carlos Villar, Thomas W Painter, Giovanni Landoni, Edith Fleischmann, Andre Lamy, Richard Whitlock, Yannick Le Manach, Meylin Aphang-Lam, Juan P Cata, Peggy Gao, Nicolaas C S Terblanche, Pamidimukkala V Ramana, Kim A Jamieson, Amal Bessissow, Gabriela R Mendoza, Silvia Ramirez, Pierre A Diemunsch, Salim Yusuf, and P J Devereaux.
- University of Alberta and Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada (M.M.G.).
- Ann. Intern. Med. 2018 Feb 20; 168 (4): 237-244.
BackgroundUncertainty remains about the effects of aspirin in patients with prior percutaneous coronary intervention (PCI) having noncardiac surgery.ObjectiveTo evaluate benefits and harms of perioperative aspirin in patients with prior PCI.DesignNonprespecified subgroup analysis of a multicenter factorial trial. Computerized Internet randomization was done between 2010 and 2013. Patients, clinicians, data collectors, and outcome adjudicators were blinded to treatment assignment. (ClinicalTrials.gov: NCT01082874).Setting135 centers in 23 countries.PatientsAdults aged 45 years or older who had or were at risk for atherosclerotic disease and were having noncardiac surgery. Exclusions were placement of a bare-metal stent within 6 weeks, placement of a drug-eluting stent within 1 year, or receipt of nonstudy aspirin within 72 hours before surgery.InterventionAspirin therapy (overall trial, n = 4998; subgroup, n = 234) or placebo (overall trial, n = 5012; subgroup, n = 236) initiated within 4 hours before surgery and continued throughout the perioperative period. Of the 470 subgroup patients, 99.9% completed follow-up.MeasurementsThe 30-day primary outcome was death or nonfatal myocardial infarction; bleeding was a secondary outcome.ResultsIn patients with prior PCI, aspirin reduced the risk for the primary outcome (absolute risk reduction, 5.5% [95% CI, 0.4% to 10.5%]; hazard ratio [HR], 0.50 [CI, 0.26 to 0.95]; P for interaction = 0.036) and for myocardial infarction (absolute risk reduction, 5.9% [CI, 1.0% to 10.8%]; HR, 0.44 [CI, 0.22 to 0.87]; P for interaction = 0.021). The effect on the composite of major and life-threatening bleeding in patients with prior PCI was uncertain (absolute risk increase, 1.3% [CI, -2.6% to 5.2%]). In the overall population, aspirin increased the risk for major bleeding (absolute risk increase, 0.8% [CI, 0.1% to 1.6%]; HR, 1.22 [CI, 1.01 to 1.48]; P for interaction = 0.50).LimitationNonprespecified subgroup analysis with small sample.ConclusionPerioperative aspirin may be more likely to benefit rather than harm patients with prior PCI.Primary Funding SourceCanadian Institutes of Health Research.
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