ASPREE: what the trial showed
In 19,114 healthy community-dwelling adults aged 70 or older, daily aspirin 100 mg did not reduce cardiovascular disease (10.7 versus 11.3 events per 1,000 person-years) but increased major haemorrhage (8.6 versus 6.2 per 1,000 person-years) over a median of 4.7 years, and all-cause mortality was higher with aspirin.
Main cited publication: Effect of Aspirin on Cardiovascular Events and Bleeding in the Healthy Elderly. New England Journal of Medicine, 2018. PMID 30221597. Results are summarized from the cited trial report and any companion publications listed below.
- ASPREE primary outcome: disability-free survival (PMID 30221596)
- ASPREE companion mortality analysis (PMID 30221595)
At a glance
| Design | Randomised, double-blind, placebo-controlled (three companion primary publications) |
|---|---|
| Population | 19,114 community-dwelling adults in Australia and the United States aged 70 or older (65 or older among Black and Hispanic participants in the US) without cardiovascular disease, dementia, or disability |
| Intervention | Enteric-coated aspirin 100 mg daily |
| Comparator | Placebo |
| Follow-up | Median 4.7 years |
| Registration | NCT01038583 |
| Funding | US National Institute on Aging and others |
Primary outcome
Death, dementia, or persistent physical disability (the composite used to assess disability-free survival; PMID 30221596).
| Enteric-coated aspirin 100 mg daily | Placebo | Effect |
|---|---|---|
| 21.5 events per 1,000 person-years | 21.2 events per 1,000 person-years | Hazard ratio 1.01 (95% CI 0.92 to 1.11); no significant benefit |
Key findings
- The cardiovascular secondary endpoint occurred at 10.7 versus 11.3 events per 1,000 person-years (HR 0.95, 95% CI 0.83 to 1.08; PMID 30221597); no significant reduction was demonstrated.
- Major haemorrhage occurred at 8.6 versus 6.2 events per 1,000 person-years (HR 1.38, 95% CI 1.18 to 1.62, P<0.001).
- In the companion mortality paper (PMID 30221595), all-cause death was 12.7 versus 11.1 per 1,000 person-years (HR 1.14, 95% CI 1.01 to 1.29), with cancer-related death the main contributor (3.1% versus 2.3%, HR 1.31).
- The trial's primary endpoint of disability-free survival showed no benefit from aspirin.
- The mortality finding was unexpected and the investigators themselves advise interpreting it with caution.
Harms and safety
- A 38% relative increase in major haemorrhage, about 2.4 extra major bleeds per 1,000 person-years.
- A numerically higher rate of death from any cause, driven by cancer deaths, of uncertain causal meaning.
Limitations
- Participants were healthy older adults without prior cardiovascular disease; the result does not apply to secondary prevention.
- The cancer mortality signal conflicts with earlier long-term data suggesting a protective effect and remains unexplained.
- Median follow-up of 4.7 years in a population with low baseline cardiovascular event rates.
Where it sits in guidelines
The 2022 USPSTF recommendation advises against initiating low-dose aspirin for primary prevention in adults aged 60 or older, and the 2021 ESC prevention guideline does not recommend antiplatelet therapy for primary prevention in people at low or moderate risk. ASPREE is a central citation for both.
CliniAtlas answers that use this trial
Written for healthcare professionals as an orientation to the primary publication, not as a substitute for reading it. For literature search, education, and professional evidence review only. Not for diagnosis, treatment selection, triage, monitoring, prognosis, or patient-specific clinical decision-making.