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What is the association of aspirin use with cardiovascular events and bleeding events in individuals without cardiovascular disease?
In this meta-analysis of 13 trials with 164 225 participants without cardiovascular disease, aspirin use was associated with a lower risk of cardiovascular events, defined as cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke (hazard ratio [HR], 0.89; absolute risk reduction, 0.41%) and an increased risk of major bleeding (HR, 1.43; absolute risk increase, 0.47%).
In individuals without cardiovascular disease, the use of aspirin was associated with a lower risk of cardiovascular events and an increased risk of major bleeding.
The role for aspirin in cardiovascular primary prevention remains controversial, with potential benefits limited by an increased bleeding risk.
To assess the association of aspirin use for primary prevention with cardiovascular events and bleeding.
PubMed and Embase were searched on Cochrane Library Central Register of Controlled Trials from the earliest available date through November 1, 2018.
Randomized clinical trials enrolling at least 1000 participants with no known cardiovascular disease and a follow-up of at least 12 months were included. Included studies compared aspirin use with no aspirin (placebo or no treatment).
Data Extraction and Synthesis
Data were screened and extracted independently by both investigators. Bayesian and frequentist meta-analyses were performed.
Main Outcomes and Measures
The primary cardiovascular outcome was a composite of cardiovascular mortality, nonfatal myocardial infarction, and nonfatal stroke. The primary bleeding outcome was any major bleeding (defined by the individual studies).
A total of 13 trials randomizing 164 225 participants with 1 050 511 participant-years of follow-up were included. The median age of trial participants was 62 years (range, 53-74), 77 501 (47%) were men, 30 361 (19%) had diabetes, and the median baseline risk of the primary cardiovascular outcome was 10.2% (range, 2.6%-30.9%). Aspirin use was associated with significant reductions in the composite cardiovascular outcome compared with no aspirin (60.2 per 10 000 participant-years with aspirin and 65.2 per 10 000 participant-years with no aspirin) (hazard ratio [HR], 0.89 [95% credible interval, 0.84-0.94]; absolute risk reduction, 0.41% [95% CI, 0.23%-0.59%]; number needed to treat, 241). Aspirin use was associated with an increased risk of major bleeding events compared with no aspirin (23.1 per 10 000 participant-years with aspirin and 16.4 per 10 000 participant-years with no aspirin) (HR, 1.43 [95% credible interval, 1.30-1.56]; absolute risk increase, 0.47% [95% CI, 0.34%-0.62%]; number needed to harm, 210).
Conclusions and Relevance
The use of aspirin in individuals without cardiovascular disease was associated with a lower risk of cardiovascular events and an increased risk of major bleeding. This information may inform discussions with patients about aspirin for primary prevention of cardiovascular events and bleeding.
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Corresponding Author: Sean L. Zheng, BM, BCh, MA, MRCP, Department of Cardiology, King’s College Hospital NHS Foundation Trust, Denmark Hill, London SE5 9RS, United Kingdom (email@example.com).
Accepted for Publication: December 3, 2018.
Correction: This article was corrected on June 11, 2019, to correct errors in the Results because 2 studies (the Prevention of Arterial Disease and Diabetes Trial and the Thrombosis Prevention Trial) that were identified in the search and included in the meta-analysis were unintentionally omitted from the analysis for the primary composite cardiovascular outcome. The Results have been corrected and now include these studies in all other outcome analyses.
Author Contributions: Dr Zheng and Mr Roddick had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Dr Zheng and Mr Roddick conducted and are responsible for the data analysis. Dr Zheng and Mr Roddick take full responsibility as first authors.
Concept and design; acquisition, analysis, or interpretation of data; drafting of the manuscript; critical revision of the manuscript for important intellectual content; statistical analysis; and administrative, technical, or material support: Both authors.
Conflict of Interest Disclosures: The authors have no conflicts of interest to disclose.
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