Does daily low-dose aspirin reduce disability-free survival in healthy seniors?
Compared to placebo, low-dose aspirin was not associated with a reduction in disability-free survival in healthy adults at or above 70 years of age but was associated with higher rates of major hemorrhage as well as all-cause mortality.
While daily Aspirin use has clear and well-described benefits for secondary prevention among patients with cardiovascular and cerebrovascular disease, its clinical utility in healthy, older adults had not previously been determined in a large trial.
The Effect of Aspirin on Disability-free Survival in the Healthy Elderly (ASPREE; 2018) trial enrolled 19,114 healthy elderly patients (≥70 years old, ≥ 65 years old in Hispanic or Black patients) without a history of cardiovascular disease, cerebrovascular disease, dementia, or any other chronic condition that would likely limit survival to less than 5 years. Patients were randomized to either Aspirin 100mg daily or placebo and followed prospectively for all-cause death, dementia, or physical disability. With a median follow-up of 4.7 years, rates of disability-free survival were similar between Aspirin and placebo groups (21.5 and 21.2 events per 1000 person-years, respectively). Additionally, the Aspirin group was linked with higher clinically-significant rates of major hemorrhage as well as all-cause mortality compared to the placebo group.
- Multicenter, randomized, double-blind, placebo-controlled
- Aspirin (n=9,525)
- Placebo (n=9,589)
- Setting: 34 sites in the United States and 16 sites in Australia
- Enrollment: 2010-2014
- Median follow-up: 4.7 years
- Analysis: Intention-to-treat
- Primary outcome: Disability-free survival
- Men and women age 70 years and older
- Ability to provide informed consent
- History of diagnosed cardiovascular event (myocardial infarction, heart failure, peripheral artery disease, angina pectoris, stroke, transient ischemic attack, >50% carotid artery stenosis, prior carotid endarterectomy, prior coronary artery angioplasty or stenting, prior coronary artery bypass graft, or known abdominal aortic aneurysm)
- Diagnosis of atrial fibrillation
- Serious intercurrent illness expected to cause death within 5 years
- A condition with high risk of bleeding (any bleeding diathesis, GI malignancy, recent PUD, liver disease, uremia, cerebral or aortic aneurysm, etc)
- Allergy to aspirin or other absolute contraindication
- Systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 105 mmHg
- Preexisting dementia or modified mini mental state exam score ≤ 77
- Preexisting difficulty performing one of the 6 Katz activities of daily living
- Pill-taking compliance < 80% during the initial run-in phase
- Median age 74 years, 56% Female
- BMI: 28.1
- Hemoglobin: 14.2
- Fasting glucose: 98.9
- HDL 61.5, total cholesterol 202.7
- Creatinine 0.9, eGFR 73
- SBP 139 ± 17 mmHg, DBP 77 ± 10 mmHg
values are means
Patients were randomized into two groups to receive either: 1) enteric-coated Aspirin 100mg daily 2) matching placebo
Presented as aspirin vs. placebo. P-Y is person-years.
- Disability-free survival (Defined as all-cause mortality, dementia, or persistent physical disability.)
- 21.5 events per 1,000 person-years in the aspirin group vs 21.2 for each 1,000 person-years in the placebo group (HR = 1.01; 95% CI, 0.92-1.11)
- All-cause mortality
- 12.7 events per 1,000 person-years in the aspirin group vs 11.1 events per 1000 person-years in the placebo group (HR, 1.14; 95% confidence interval [CI], 1.01 to 1.29)
- Cancer-related death
- 6.7 events per 1,000 person-years in the aspirin group vs 5.1 events per 1000 person-years in the placebo group (HR, 1.31; 95% CI, 1.10 to 1.56)
- % vs. % (## HR; 95% CI ##-##; P=##; NNH=##)
- possible lack of generalizability (91.3% of participants were white)