Daily aspirin in older adults shows no cardiovascular benefit, increases bleeding risk, ASPREE-XT confirms
Healthy older adults taking daily low-dose aspirin for primary prevention gain no long-term protection against heart attack or stroke and face a higher risk of major bleeding, according to new research from Monash University and collaborators published in the European Heart Journal. The analysis extends the landmark ASPREE clinical trial with an additional 4.3 years of post-trial follow-up in the ASPREE-eXTension study, yielding a combined median follow-up of 8.3 years.
The cohort included 15,668 adults in Australia and the US, predominantly aged 70 years or older at entry, who began the original trial without a history of cardiovascular events, dementia, or independence-limiting physical disability. Participants had been randomly assigned to 100 mg of aspirin daily or placebo during the ASPREE trial’s median 4.7-year treatment phase and were then observed in ASPREE-XT after the trial ended.
What the researchers found
- There was no evidence overall that daily aspirin prevented major cardiovascular events during the combined 8.3-year follow-up.
- Major haemorrhage occurred more often in the group originally randomized to aspirin than in those assigned to placebo.
- In the post-trial phase, participants initially assigned to aspirin experienced a 17% increase in major adverse cardiovascular events compared with those initially assigned to placebo, a finding the investigators described as unexpected.
Why this matters for primary prevention
The new results confirm the 2018 ASPREE trial findings: for healthy older adults without prior cardiovascular disease, routine daily aspirin does not deliver cardiovascular protection and increases the risk of serious bleeding. The investigators emphasize that people taking aspirin solely for possible primary prevention should discuss with their doctor whether to continue. This advice does not apply to secondary prevention—individuals with a prior heart attack, stroke, stent, or other cardiovascular event should not stop prescribed aspirin without medical guidance.
Study design at a glance
- Population: 15,668 community-dwelling older adults in Australia and the US, mostly aged 70+.
- Intervention: 100 mg aspirin daily versus placebo during the ASPREE randomized phase (median 4.7 years).
- Follow-up: Additional median 4.3 years observational follow-up in ASPREE-XT; total median follow-up 8.3 years.
- Outcomes: Major adverse cardiovascular events and major haemorrhage, assessed during and after the randomized phase.
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Expert perspective and clinical takeaway
Investigators from the Monash School of Public Health and Preventive Medicine report that the long-term trajectory for healthy older adults favors avoiding routine aspirin for primary prevention because the bleeding harms outweigh the cardiovascular benefits. They note that some individuals at uniquely high cardiovascular risk may still be considered on a case-by-case basis, but only after a careful risk–benefit discussion with a GP.
Funding and stewardship
ASPREE and ASPREE-XT are led by Monash University and the Berman Center for Outcomes & Clinical Research, funded by the National Institutes of Health in the US and the NHMRC in Australia. The program continues as a longitudinal study to inform safe, evidence-based prevention in aging populations.
Responsible use note
This report is informational and is not a substitute for personalized medical advice. Older adults should consult their GP before starting or stopping aspirin.
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