Michelle M. Graham, MD; Daniel I. Sessler, MD; Joel L. Parlow, MD, MSc; Bruce M. Biccard, MBChB, MMedSci, PhD; Gordon Guyatt, MD, MSc; Kate Leslie, MBBS, MD, MEpi; Matthew T.V. Chan, MBBS, PhD; Christian S. Meyhoff, MD, PhD; Denis Xavier, MD, MSc; Alben Sigamani, MBBS, MD; Priya A. Kumar, MD; Marko Mrkobrada, MD, MSc; Deborah J. Cook, MD, MSc; Vikas Tandon, MD; Jesus Alvarez-Garcia, MD, PhD; Juan Carlos Villar, MD, PhD; Thomas W. Painter, MBChB; Giovanni Landoni, MD; Edith Fleischmann, MD; Andre Lamy, MD, MSc; Richard Whitlock, MD, PhD; Yannick Le Manach, MD, PhD; Meylin Aphang-Lam, MD; Juan P. Cata, MD; Peggy Gao, MSc; Nicolaas C.S. Terblanche, MD, MMed; Pamidimukkala V. Ramana, MBBS; Kim A. Jamieson, MBChB; Amal Bessissow, MD, MSc; Gabriela R. Mendoza, MD; Silvia Ramirez, MD; Pierre A. Diemunsch, MD, PhD; Salim Yusuf, MD, DPhil; P.J. Devereaux, MD, PhD
Financial Support: By the Canadian Institutes of Health Research, the Australian National Health and Medical Research Council, the Spanish Ministry of Health and Social Policy, and Boehringer Ingelheim.
Disclosures: Dr. Sessler reports grants from the Canadian Institutes of Health Research during the conduct of the study. Dr. Meyhoff reports grants from Ferring Pharmaceuticals, Merck Sharp & Dohme, and Boehringer Ingelheim outside the submitted work. Dr. Xavier reports grants from Cadila Pharmaceuticals; Boehringer Ingelheim; AstraZeneca India; Sanofi-Aventis; Pfizer; National Institutes of Health; National Heart, Lung, and Blood Institute; Bristol-Myers Squibb; and UnitedHealth outside the submitted work. Dr. Painter reports grants from the Australian and New Zealand College of Anaesthetists Research Foundation outside the submitted work. Dr. Diemunsch reports personal fees from Ambu and the French government and grants and personal fees from Fisher & Paykel outside the submitted work. Dr. Yusuf reports grants and personal fees from Bayer and AstraZeneca and grants from Boehringer Ingelheim and Cadila Pharmaceuticals outside the submitted
work. Dr. Devereaux reports grants from Abbott Diagnostics, Boehringer Ingelheim, Covidien, Octapharma, Philips Healthcare, Roche Diagnostics, and Stryker outside the submitted work and participating in an advisory board meeting for GlaxoSmithKline, an expert panel meeting for AstraZeneca, and consultancy meetings for Boehringer Ingelheim (2014) and Roche Diagnostics (2016). Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M17-2341.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.
Reproducible Research Statement:Study protocol: Available at ClinicalTrials.gov. Statistical code and data set: Not available.
Requests for Single Reprints: P.J. Devereaux, MD, PhD, Population Health Research Institute, David Braley Cardiac, Vascular, and Stroke Research Institute, Room C1-116, Perioperative Medicine and Surgical Research Unit, c/o Hamilton General Hospital, 237 Barton Street East, Hamilton, Ontario L8L 2X2, Canada; e-mail, email@example.com.
Current Author Addresses: Dr. Graham: 2C2 WMC University of Alberta Hospital, 8440 112 Street NW, Edmonton, Alberta T6R 3S8, Canada.
Dr. Sessler: Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195.
Dr. Parlow: Department of Anesthesiology and Perioperative Medicine, Queen's University, 99 University Avenue, Kingston, Ontario K7L 3N6, Canada.
Dr. Biccard: D23 Department of Anaesthesia and Perioperative Medicine, D23 Groote Schuur Hospital, Anzio Road, Observatory, 7925, South Africa.
Dr. Guyatt: Health Sciences Centre, 2C12, 1200 Main Street West, Hamilton, Ontario L8N 3Z5, Canada.
Dr. Leslie: Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, 300 Grattan Street, Parkille, Victoria 3050, Australia.
Dr. Chan: Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, 4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, New Territories, Hong Kong Special Administrative Region, China.
Dr. Meyhoff: Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Bispebjerg Bakke 23, DK-2400 Copenhagen, Denmark.
Dr. Xavier: Department of Pharmacology and Division of Clinical Research and Training, St. John's Medical College and Research Institute, 100 Feet Road, John Nagar, Koramangala, Bengaluru, Karnataka 560034, India.
Dr. Sigamani: Narayana Hrudayalaya Limited, NH Health City, Bommasandra Industrial Area, Bangalore, Karnataka 560099, India.
Dr. Kumar: Department of Anesthesiology, N2198, UNC Hospitals, Chapel Hill, NC 27599-7010.
Dr. Mrkobrada: Department of Medicine, Schulich School of Medicine and Dentistry, 339 Windermere Road, Room B9-100, London, Ontario N6A 5A5, Canada.
Dr. Cook: Health Sciences Centre, 2C, 1280 Main Street West, Hamilton, Ontario L8S 4K1, Canada.
Dr. Tandon: St. Joseph's Healthcare, F543, 50 Charlton Avenue East, Hamilton, Ontario L8N 4A6, Canada.
Dr. Alvarez-Garcia: Cardiology Department, Sant Pau Hospital and Biomedical Research Institute, Autonomous University of Barcelona, Research Center of Cardiovascular Diseases (CIBERCV), Sant Antoni Maria Claret, 167 Pavelló de Sant Frederic, planta 1ï¿½ 08025 Barcelona 93 553 78 55, Spain.
Dr. Villar: Fundación Cardioinfantil, Instituto de Cardiología, Calle 163A # 13B-60, Departamento de Investigaciones, Torre H, Piso 3, Bogotá, Colombia.
Dr. Painter: Department of Anaesthesia, Royal Adelaide Hospital, Port Road, South Australia 5000, Australia.
Dr. Landoni: Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Ospedale San Raffaele-Milano, via Olgettina 60, 20132 Milan, Italy.
Dr. Fleischmann: Medical University of Vienna, Spitalgasse 23, 1090 Wien, Vienna, Austria.
Drs. Lamy, Whitlock, Le Manach, Yusuf, and Devereaux and Ms. Gao: Population Health Research Institute, David Braley Cardiac, Vascular and Stroke Research Institute, c/o Hamilton General Hospital, 237 Barton Street East, Hamilton, Ontario L8L 2X2, Canada.
Dr. Aphang-Lam: Department of Internal Medicine, Hospital Arzobispo Loayza, Avenida Alfonso Ugarte 848, Cercado de Lima 15082, Peru.
Dr. Cata: Department of Anesthesiology and Perioperative Medicine, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX 77030.
Dr. Terblanche: Level 4 H, 48 Liverpool Street, Hobart, Tasmania 7000, Australia.
Dr. Ramana: Department of Neurosurgery and Spine Surgery, CARE Hospitals, 17-1-1, KGH Road, Maharani Peta, Visakhapatnam, Andhra Pradesh 530002, India.
Dr. Jamieson: Auckland City Hospital, Adult and Emergency Anaesthesia, Level 8, 2 Park Road, Grafton, Auckland 1124, New Zealand.
Dr. Bessissow: McGill University Health Centre/Montreal General Hospital, 1650 Cedar Avenue Room C2 101.7, Montreal, Quebec H3G 1A4, Canada.
Dr. Mendoza: Department of Anesthesia, Hospital Italiano de Buenos Aires, Tte. Gral. Juan Domingo Perón 4190, C1199ABB CABA, Buenos Aires, Argentina.
Dr. Ramirez: Department of Anesthesia, Hospital Universitario Fundación Hospital Alcorcon, Calle Budapest, 1, 28922 Alcorcón, Madrid, Spain.
Dr. Diemunsch: Anesthésie Réanimation, CHU de Hautepierre, 1 Avenue Molière, 67200 Strasbourg, France.
Author Contributions: Conception and design: M.M. Graham, D.I. Sessler, G. Guyatt, M.T.V. Chan, M. Mrkobrada, J.C. Villar, S. Yusuf, P.J. Devereaux.
Analysis and interpretation of the data: D.I. Sessler, M.T.V. Chan, C.S. Meyhoff, D. Xavier, M. Mrkobrada, J. Alvarez-Garcia, J.C. Villar, G. Landoni, A. Lamy, Y. Le Manach, M. Aphang-Lam, P. Gao, N.C.S. Terblanche, P.A. Diemunsch, S. Yusuf, P.J. Devereaux.
Drafting of the article: M.M. Graham, P.J. Devereaux.
Critical revision of the article for important intellectual content: M.M. Graham, D.I. Sessler, J.L. Parlow, B.M. Biccard, G. Guyatt, C.S. Meyhoff, D. Xavier, A. Sigamani, P.A. Kumar, D.J. Cook, J. Alvarez-Garcia, J.C. Villar, T.W. Painter, G. Landoni, R. Whitlock, Y. Le Manach, P.V. Ramana, A. Bessissow, P.A. Diemunsch, S. Yusuf, P.J. Devereaux.
Final approval of the article: M.M. Graham, D.I. Sessler, J.L. Parlow, B.M. Biccard, G. Guyatt, K. Leslie, M.T.V. Chan, C.S. Meyhoff, D. Xavier, A. Sigamani, P.A. Kumar, M. Mrkobrada, D.J. Cook, V. Tandon, J. Alvarez-Garcia, J.C. Villar, T.W. Painter, G. Landoni, E. Fleischmann, A. Lamy, R. Whitlock, Y. Le Manach, M. Aphang-Lam, J.P. Cata, P. Gao, N.C.S. Terblanche, P.V. Ramana, K.A. Jamieson, A. Bessissow, G.R. Mendoza, S. Ramirez, P.A. Diemunsch, S. Yusuf, P.J. Devereaux.
Provision of study materials or patients: M.M. Graham, B.M. Biccard, C.S. Meyhoff, D. Xavier, A. Sigamani, P.A. Kumar, V. Tandon, J. Alvarez-Garcia, J.C. Villar, G. Landoni, M. Aphang-Lam, J.P. Cata, N.C.S. Terblanche, P.V. Ramana, K.A. Jamieson, G.R. Mendoza, S. Ramirez, P.A. Diemunsch, P.J. Devereaux.
Statistical expertise: Y. Le Manach, P. Gao, P.J. Devereaux.
Obtaining of funding: C.S. Meyhoff, A. Sigamani, M. Mrkobrada, D.J. Cook, R. Whitlock, S. Yusuf, P.J. Devereaux.
Administrative, technical, or logistic support: D.I. Sessler, B.M. Biccard, A. Sigamani, K.A. Jamieson, S. Yusuf, P.J. Devereaux.
Collection and assembly of data: D.I. Sessler, J.L. Parlow, B.M. Biccard, K. Leslie, M.T.V. Chan, C.S. Meyhoff, D. Xavier, A. Sigamani, P.A. Kumar, M. Mrkobrada, V. Tandon, J. Alvarez-Garcia, J.C. Villar, T.W. Painter, G. Landoni, E. Fleischmann, N.C.S. Terblanche, K.A. Jamieson, P.A. Diemunsch, P.J. Devereaux.
Uncertainty remains about the effects of aspirin in patients with prior percutaneous coronary intervention (PCI) having noncardiac surgery.
To evaluate benefits and harms of perioperative aspirin in patients with prior PCI.
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)
135 centers in 23 countries.
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.
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.
The 30-day primary outcome was death or nonfatal myocardial infarction; bleeding was a secondary outcome.
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).
Nonprespecified subgroup analysis with small sample.
Perioperative aspirin may be more likely to benefit rather than harm patients with prior PCI.
Canadian Institutes of Health Research.
Graham MM, Sessler DI, Parlow JL, Biccard BM, Guyatt G, Leslie K, et al. Aspirin in Patients With Previous Percutaneous Coronary Intervention Undergoing Noncardiac Surgery. Ann Intern Med. ;168:237–244. doi: 10.7326/M17-2341
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Published: Ann Intern Med. 2018;168(4):237-244.
Published at www.annals.org on 14 November 2017
Cardiology, Coronary Heart Disease, Percutaneous Coronary Intervention.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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