Journal article
Aspirin, cardiovascular events, and major bleeding in older adults: extended follow-up of the ASPREE trial
European heart journal, Vol.46(42), pp.4410-4422
11/07/2025
DOI: 10.1093/eurheartj/ehaf514
PMCID: PMC12596486
PMID: 40796244
Abstract
Guidelines recommend against routine initiation of low-dose aspirin in older adults for primary prevention of atherosclerotic cardiovascular disease events. This study aimed to estimate long-term and post-trial effects of aspirin on major adverse cardiovascular events (MACE) and major haemorrhage using extended follow-up of participants from the ASPREE trial.
In-trial (2010-17) and post-trial (2017-22) data were analysed. At enrolment, participants were aged ≥70 years (≥65 years for US minorities) without prior cardiovascular events, dementia, or independence-limiting physical disability. Randomization was to daily low-dose aspirin or matching placebo for the 4.7 years of the trial.
Of the 19 114 participants randomized (9525 aspirin, 9589 placebo), 15 668 without in-trial MACE consented to post-trial follow-up. No long-term benefit of randomization to aspirin was observed for MACE for the entire in-trial and post-trial period [hazard ratio (HR) 1.04, 95% confidence interval (CI) .94, 1.15]. However, during the post-trial period (median 4.3 years), there was a higher rate of MACE (HR 1.17, 95% CI 1.01, 1.36) in those randomized to aspirin compared with placebo. Over the entire period, a higher rate of major haemorrhage was observed in the randomized aspirin group compared with placebo (HR 1.24, 95% CI 1.10, 1.39).
The present study provides novel evidence concerning long-term MACE and haemorrhage following aspirin use in initially healthy older adults. The finding of no long-term MACE benefit needs to be considered in clinical decision-making if aspirin is being considered for use in this context.
Details
- Title: Subtitle
- Aspirin, cardiovascular events, and major bleeding in older adults: extended follow-up of the ASPREE trial
- Creators
- Rory Wolfe - Monash UniversityJonathan C Broder - Monash UniversityZhen Zhou - Monash UniversityAnne M Murray - Hennepin Healthcare Research InstituteJoanne Ryan - Monash UniversityAndrew T Chan - Massachusetts General HospitalMark R Nelson - University of TasmaniaRobyn L Woods - Monash UniversityMichael E Ernst - University of IowaSuzanne G Orchard - Monash UniversityBrenda Kirpach - Berman Center for Outcomes and Clinical ResearchChristopher M Reid - Curtin UniversityRaj C Shah - Rush University Medical CenterNigel Stocks - The University of AdelaideKaren L Margolis - HealthPartnersJohannes T Neumann - German Center for Cardiovascular Research (DZHK), Partner Site, Hamburg/Kiel/Lübeck, Hamburg, GermanyMichelle Wilson - Monash UniversitySharyn Fitzgerald - Monash UniversitySuzanne E Mahady - Monash UniversityErica M Wood - Monash UniversityShara Ket - Monash UniversityCharles B Eaton - Brown UniversityPeter Hand - Monash UniversityMobin Malik - United Heart and Vascular ClinicWalter P Abhayaratna - Australian National UniversityPrasanna Venkataraman - Monash UniversityPeter Chan - Monash UniversityGeoffrey C Cloud - Monash UniversityGeoffrey A Donnan - The Royal Melbourne HospitalJeff D Williamson - Wake Forest UniversityAndrew M Tonkin - Monash University
- Resource Type
- Journal article
- Publication Details
- European heart journal, Vol.46(42), pp.4410-4422
- DOI
- 10.1093/eurheartj/ehaf514
- PMID
- 40796244
- PMCID
- PMC12596486
- NLM abbreviation
- Eur Heart J
- ISSN
- 1522-9645
- eISSN
- 1522-9645
- Publisher
- OXFORD UNIV PRESS
- Grant note
- 334047 / NIH HHS National Health and Medical Research Council of Australia 1127060 / NIH HHS R35 CA253185 / NCI NIH HHS National Institute on Aging and the National Cancer Institute Monash University
- Language
- English
- Electronic publication date
- 08/12/2025
- Date published
- 11/07/2025
- Academic Unit
- Family and Community Medicine; Pharmacy Practice and Science
- Record Identifier
- 9984946838902771
Metrics
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