- Question
- Does low-dose aspirin reduce cardiovascular events for primary prevention in older Japanese patients with atherosclerotic risk factors?
- Design
- Multicenter, open-label, randomized (1:1), parallel-group trial of 14464 patients recruited by primary care physicians at 1007 clinics in Japan. An expert panel blinded to treatment assignment adjudicated outcomes. The trial was stopped early for likely futility after a median follow-up of 5.02 years.
- Population
- Patients aged 60 to 85 years with hypertension, dyslipidemia or diabetes mellitus, without established cardiovascular disease.
- Intervention
- Enteric-coated aspirin 100 mg/d in addition to ongoing medications.
- Control
- No aspirin, with ongoing medications continued.
- Primary outcome
- Composite of cardiovascular death, nonfatal stroke (ischemic, hemorrhagic or undefined cerebrovascular event) and nonfatal myocardial infarction.
- Results
- The 5-year cumulative primary event rate did not differ between groups: 2.77% with aspirin vs 2.96% with no aspirin (HR 0.94; 95% CI 0.77-1.15; P = .54). Aspirin reduced nonfatal myocardial infarction (HR 0.53; 95% CI 0.31-0.91; P = .02).
- Safety
- Aspirin increased extracranial hemorrhage requiring transfusion or hospitalization (HR 1.85; 95% CI 1.22-2.81; P = .004).
- Conclusion
- Once-daily low-dose aspirin did not significantly reduce the composite of cardiovascular death, nonfatal stroke and nonfatal myocardial infarction in this population.
- Why it matters
- It helped call into question the benefit of aspirin for primary prevention in older adults, showing that bleeding risk can offset potential benefit.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 18, 2026