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 all-cause mortality
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
Significant
increase ▲
Significant increase in the incidence of all-cause mortality (12.7/1000 py vs. 11.1/1000 py; HR 1.14, 95% CI 1.01 to 1.29).
Secondary outcomes
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 all-cause mortality.
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.
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