Michelle M Graham1, Daniel I Sessler2, Joel L Parlow3, Bruce M Biccard4, Gordon Guyatt5, Kate Leslie6, Matthew T V Chan7, Christian S Meyhoff8, Denis Xavier9, Alben Sigamani10, Priya A Kumar11, Marko Mrkobrada12, Deborah J Cook5, Vikas Tandon5, Jesus Alvarez-Garcia13, Juan Carlos Villar14, Thomas W Painter15, Giovanni Landoni16, Edith Fleischmann17, Andre Lamy5, Richard Whitlock5, Yannick Le Manach5, Meylin Aphang-Lam18, Juan P Cata19, Peggy Gao5, Nicolaas C S Terblanche20, Pamidimukkala V Ramana21, Kim A Jamieson22, Amal Bessissow23, Gabriela R Mendoza24, Silvia Ramirez25, Pierre A Diemunsch26, Salim Yusuf5, P J Devereaux5. 1. University of Alberta and Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada (M.M.G.). 2. Cleveland Clinic, Cleveland, Ohio (D.I.S.). 3. Queen's University, Kingston, Ontario, Canada (J.L.P.). 4. Groote Schuur Hospital and University of Cape Town, Western Cape, South Africa (B.M.B.). 5. Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada (G.G., D.J.C., V.T., A.L., R.W., Y.L., P.G., S.Y., P.D.). 6. Royal Melbourne Hospital, Melbourne Medical School, University of Melbourne, and Monash University, Melbourne, Victoria, Australia (K.L.). 7. The Chinese University of Hong Kong, Hong Kong, China (M.T.C.). 8. Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark (C.S.M.). 9. St. John's Medical College and Research Institute, Bangalore, India (D.X.). 10. Narayana Hrudayalaya, Bangalore, India (A.S.). 11. University of North Carolina, Chapel Hill, North Carolina (P.A.K.). 12. Schulich School of Medicine & Dentistry at Western University, London, Ontario, Canada (M.M.). 13. Sant Pau Hospital and Biomedical Research Institute, Autonomous University of Barcelona, Research Center of Cardiovascular Diseases (CIBERCV), Barcelona, Spain (J.A.). 14. Fundación Cardioinfantil Instituto de Cardiología, Bogotá, Colombia, and Department of Medicine, Universidad Autónoma de Bucaramanga, Santander, Colombia (J.C.V.). 15. University of Adelaide and Royal Adelaide Hospital, Adelaide, Australia (T.W.P.). 16. IRCCS San Raffaele Scientific Institute and Vita-Salute San Raffaele University, Milan, Italy (G.L.). 17. Medical University of Vienna, Vienna, Austria (E.F.). 18. Hospital Arzobispo Loayza, Universidad Peruana Cayetano Heredia, Lima, Peru (M.A.). 19. The University of Texas MD Anderson Cancer Center, Houston, Texas (J.P.C.). 20. Royal Hobart Hospital and University of Tasmania, Hobart, Tasmania, Australia (N.C.T.). 21. CARE Hospitals, Maharanipeta, Visakhapatnam, India (P.V.R.). 22. Auckland City Hospital, Auckland, New Zealand (K.A.J.). 23. McGill University Health Centre, Montréal, Québec, Canada (A.B.). 24. Hospital Italiano de Buenos Aires, Buenos Aires, Argentina (G.R.M.). 25. Hospital Universitario Fundación Hospital Alcorcon, Madrid, Spain (S.R.). 26. Centre Hospitalier Universitaire de Hautepierre, Strasbourg, France (P.A.D.).
Abstract
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) orplacebo (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.
RCT Entities:
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.