ASPREE (secondary analysis)
Trial question
What is the role of low-dose aspirin in community-dwelling 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: adults, aged ≥ 70 years, without a history of AF, stroke, TIA, or myocardial infarction
Key exclusion criteria: past history of a cardiovascular event or established CVD or AF; dementia; conditions with a high current or recurrent risk of bleeding; anemia; conditions likely to cause death within 5 years; uncontrolled hypertension
Interventions
N=9525 low-dose aspirin (100 mg enteric-coated aspirin)
N=9589 placebo (matching placebo)
Primary outcome
Ischemic stroke
1.5
1.7
1.7 %
1.3 %
0.8 %
0.4 %
0.0 %
Low-dose aspirin
Placebo
No significant difference ↔
No significant difference in ischemic stroke (1.5% vs. 1.7%; HR 0.89, 95% CI 0.71 to 1.11)
Secondary outcomes
No significant difference in hemorrhagic stroke (0.5% vs. 0.4%; HR 1.33, 95% CI 0.87 to 2.04)
No significant difference in other intracranial bleeding (0.6% vs. 0.4%; HR 1.45, 95% CI 0.98 to 2.16)
Significant increase in total intracranial bleeding (1.1% vs. 0.8%; HR 1.38, 95% CI 1.03 to 1.84)
Conclusion
In adults, aged ≥ 70 years, without a history of AF, stroke, TIA, or myocardial infarction, low-dose aspirin was not superior to placebo with respect to ischemic stroke.
Reference
Geoffrey C Cloud, Jeff D Williamson, Le Thi Phuong Thao et al. Low-Dose Aspirin and the Risk of Stroke and Intracerebral Bleeding in Healthy Older People: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Jul 3;6(7):e2325803.
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