Aspirin in Patients With Previous Percutaneous Coronary Intervention Undergoing Noncardiac Surgery.

Graham, Michelle M; Sessler, Daniel I; Parlow, Joel L; Biccard, Bruce M; Guyatt, Gordon; Leslie, Kate; Chan, Matthew T V; Meyhoff, Christian S; Xavier, Denis; Sigamani, Alben; Kumar, Priya A; Mrkobrada, Marko; Cook, Deborah J; Tandon, Vikas; Alvarez-Garcia, Jesus; Villar, Juan Carlos; Painter, Thomas W; Landoni, Giovanni; Fleischmann, Edith; Lamy, Andre; Whitlock, Richard; Le Manach, Yannick; Aphang-Lam, Meylin; Cata, Juan P; Gao, Peggy; Terblanche, Nicolaas C S; Ramana, Pamidimukkala V; Jamieson, Kim A; Bessissow, Amal; Mendoza, Gabriela R; Ramirez, Silvia; Diemunsch, Pierre A; Yusuf, Salim; Devereaux, P J

Background Uncertainty remains about the effects of aspirin in patients with prior percutaneous coronary intervention (PCI) having noncardiac surgery. Objective To evaluate benefits and harms of perioperative aspirin in patients with prior PCI. Design Nonprespecified 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). Setting 135 centers in 23 countries. Patients Adults 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. Intervention Aspirin 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. Measurements The 30-day primary outcome was death or nonfatal myocardial infarction; bleeding was a secondary outcome. Results In 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). Limitation Nonprespecified subgroup analysis with small sample. Conclusion Perioperative aspirin may be more likely to benefit rather than harm patients with prior PCI. Primary Funding Source Canadian Institutes of Health Research.