Author + information
- Received December 5, 2018
- Revision received March 10, 2019
- Accepted March 12, 2019
- Published online June 10, 2019.
- Hesham K. Abdelaziz, MD, PhDa,b,∗,
- Marwan Saad, MD, PhDb,c,∗@MarwanSaadMD,
- Naga Venkata K. Pothineni, MDc,
- Michael Megaly, MD, MSd,e,
- Rahul Potluri, MDf,
- Mohammed Saleh, MDg,
- David Lai Chin Kon, MDa,
- David H. Roberts, MDa,
- Deepak L. Bhatt, MD, MPHh@DLBHATTMD,
- Herbert D. Aronow, MD, MPHi@herbaronowMD,
- J. Dawn Abbott, MDi@JDawnAbbott1 and
- Jawahar L. Mehta, MD, PhDc,∗ (, )@chandu991
- aLancashire Cardiac Center, Blackpool Victoria Hospital, Blackpool, United Kingdom
- bDepartment of Cardiovascular Medicine, Ain Shams University, Cairo, Egypt
- cDivision of Cardiovascular Medicine, University of Arkansas for Medical Sciences and The Central Arkansas Veterans Healthcare System, Little Rock, Arkansas
- dMinneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, Minnesota
- eHennepin Healthcare, Minneapolis, Minnesota
- fAston Medical School, School of Medical Sciences, Aston University, Birmingham, United Kingdom
- gDepartment of Medicine, Creighton University, Omaha, Nebraska
- hBrigham and Women’s Hospital Heart & Vascular Center, Harvard Medical School, Boston, Massachusetts
- iDivision of Cardiovascular Medicine, The Warren Alpert Medical School of Brown University and Lifespan Cardiovascular Institute, Providence, Rhode Island
- ↵∗Address for correspondence:
Dr. Jawahar L. Mehta, University of Arkansas for Medical Sciences, 4301 West Markham Street, Little Rock, Arkansas 72205.
Background The efficacy and safety of aspirin for primary prevention of cardiovascular disease (CVD) remain debatable.
Objectives The purpose of this study was to examine the clinical outcomes with aspirin for primary prevention of CVD after the recent publication of large trials adding >45,000 individuals to the published data.
Methods Randomized controlled trials comparing clinical outcomes with aspirin versus control for primary prevention with follow-up duration of ≥1 year were included. Efficacy outcomes included all-cause death, cardiovascular (CV) death, myocardial infarction (MI), stroke, transient ischemic attack (TIA), and major adverse cardiovascular events. Safety outcomes included major bleeding, intracranial bleeding, fatal bleeding, and major gastrointestinal (GI) bleeding. Random effects DerSimonian-Laird risk ratios (RRs) for outcomes were calculated.
Results A total of 15 randomized controlled trials including 165,502 participants (aspirin n = 83,529, control n = 81,973) were available for analysis. Compared with control, aspirin was associated with similar all-cause death (RR: 0.97; 95% confidence interval [CI]: 0.93 to 1.01), CV death (RR: 0.93; 95% CI: 0.86 to 1.00), and non-CV death (RR: 0.98; 95% CI: 0.92 to 1.05), but a lower risk of nonfatal MI (RR: 0.82; 95% CI: 0.72 to 0.94), TIA (RR: 0.79; 95% CI: 0.71 to 0.89), and ischemic stroke (RR: 0.87; 95% CI: 0.79 to 0.95). Aspirin was associated with a higher risk of major bleeding (RR: 1.5; 95% CI: 1.33 to 1.69), intracranial bleeding (RR: 1.32; 95% CI: 1.12 to 1.55), and major GI bleeding (RR: 1.52; 95% CI: 1.34 to 1.73), with similar rates of fatal bleeding (RR: 1.09; 95% CI: 0.78 to 1.55) compared with the control subjects. Total cancer and cancer-related deaths were similar in both groups within the follow-up period of the study.
Conclusions Aspirin for primary prevention reduces nonfatal ischemic events but significantly increases nonfatal bleeding events.
↵∗ Drs. Abdelaziz and Saad contributed equally to this work and are joint first authors.
Dr. Bhatt has served on the Advisory Board of Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, PhaseBio, and Regado Biosciences; has served on the Board of Directors of Boston VA Research Institute, Society of Cardiovascular Patient Care, and TobeSoft; has served as Chair of the American Heart Association Quality Oversight Committee, NCDR-ACTION Registry Steering Committee, and VA CART Research and Publications Committee; has served on Data Monitoring Committees for Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Cleveland Clinic, Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi-Sankyo), and Population Health Research Institute; has received honoraria from American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Vice-Chair, ACC Accreditation Committee), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim), Belvoir Publications (Editor-in-Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees), HMP Global (Editor-in-Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national co-leader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), and WebMD (CME steering committees); has served as Deputy Editor of Clinical Cardiology; has received research funding from Abbott, Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi, Eisai, Ethicon, Forest Laboratories, Idorsia, Ironwood, Ischemix, Lilly, Medtronic, PhaseBio, Pfizer, Regeneron, Roche, Sanofi, Synaptic, and The Medicines Company; has received royalties from Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease); has served as Site Co-Investigator for Biotronik, Boston Scientific, St. Jude Medical (now Abbott), and Svelte; has served as a Trustee of the American College of Cardiology; and has performed unfunded research for FlowCo, Merck, Novo Nordisk, PLx Pharma, and Takeda. Dr. Abbott has received research grants with no direct compensation from Sinomed, Abbott Vascular, Biosensors Research, Bristol-Myers Squibb, AstraZeneca, and CSL Behring. Dr. Mehta has served as consultant to Bayer, Boehringer Ingelheim, AstraZeneca, MedImmmune, and Pfizer; and has received grant support from Bayer, Boehringer Ingelheim, and AstraZeneca, and the Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, Biomedical Laboratory Research and Development (Washington, DC) (grant No BX-000282-05). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Received December 5, 2018.
- Revision received March 10, 2019.
- Accepted March 12, 2019.
- 2019 American College of Cardiology Foundation
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