ASPREE
Trial question
What is the effect of daily aspirin in otherwise healthy older adults?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
56.0% female
44.0% male
N = 19114
19114 patients (10782 female, 8332 male)
Inclusion criteria: adult healthy patients (≥ 65 years of age) without CVD, dementia, or disability
Key exclusion criteria: history of a diagnosed CVD event, AF, serious illness likely to cause death within the next 5 years, current or recurrent condition with a high risk of major bleeding, uncontrolled BP, anemia, current use of aspirin for secondary prevention, or current continuous use of other antiplatelet drug or anticoagulant
Interventions
N=9525 aspirin (100 mg daily)
N=9589 placebo (matching tablet)
Primary outcome
Incidence of death from all causes
12.7
11.1
12.7/1000 py
9.5/1000 py
6.3/1000 py
3.2/1000 py
0.0/1000 py
Aspirin
Placebo
Borderline significant increase ▲
Borderline significant increase in the incidence of death from all causes (12.7/1000 py vs. 11.1/1000 py; HR 1.14, 95% CI 1.01 to 1.29)
Secondary outcomes
Borderline significant increase in cancer-related death (3.1% vs. 2.3%; HR 1.31, 95% CI 1.1 to 1.56)
No significant difference in death from CVD, including ischemic stroke (1% vs. 1.2%; HR 0.82, 95% CI 0.62 to 1.08)
No significant difference in death from major hemorrhage, including hemorrhagic stroke (0.3% vs. 0.3%; HR 1.13, 95% CI 0.66 to 1.94)
Conclusion
In adult healthy patients (≥ 65 years of age) without CVD, dementia, or disability, aspirin was inferior to placebo with respect to the incidence of death from all causes.
Reference
McNeil JJ, Nelson MR, Woods RL et al. Effect of Aspirin on All-Cause Mortality in the Healthy Elderly. N Engl J Med. 2018 Oct 18;379(16):1519-1528.
Open reference URL