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evident
Original paper
2018NEJMPreventive/Primary Care

ASPREE

Effect of Aspirin on Disability-free Survival in the Healthy Elderly

RCTPrimary prevention

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Overview

In healthy older adults, 100 mg aspirin did not prolong disability-free survival and increased major hemorrhage versus placebo.

Clinical takeaway

Do not start low-dose aspirin in healthy older adults expecting a longer life free of death, dementia, or persistent physical disability. That primary composite was unchanged, and major hemorrhage was higher.

Key result

The composite of death, dementia, or persistent physical disability was 21.5 versus 21.2 events per 1000 person-years (HR 1.01; 95% CI 0.92-1.11; P=0.79). Major hemorrhage: 3.8% versus 2.8% (HR 1.38; 95% CI 1.18-1.62; P<0.001).

Practice impact

Do not start 100 mg aspirin for a longer disability-free life in healthy older adults; it increases major bleeding without that gain.

Evidence

Study design

Randomized, placebo-controlled trial of 100 mg enteric-coated aspirin in community-dwelling older adults.

Enrollment

19,114

Follow-up

Median 4.7 years. The trial was terminated after a determination of no benefit on the primary end point with continued aspirin.

Geography

Australia, United States

Clinical question

Does daily low-dose aspirin prolong disability-free survival in healthy older adults?

Population

  • Community-dwelling adults 70 years of age or older, or 65 years or older among Black and Hispanic participants in the United States, without cardiovascular disease, dementia, or physical disability.

Intervention

Enteric-coated aspirin 100 mg daily, orally.

Comparator

Placebo.

Primary outcome

Composite of death, dementia, or persistent physical disability.

Aspirin did not prolong disability-free survival compared with placebo (21.5 versus 21.2 events per 1000 person-years).

Hazard ratio / 1.01 / 95% CI 0.92-1.11 / p=0.79

Key results

  • Of 19,114 enrolled participants (median age 74 years), 9525 were assigned to aspirin and 9589 to placebo.
  • The trial was terminated at a median of 4.7 years of follow-up after a determination that continued aspirin would not benefit the primary end point.
  • Primary composite of death, dementia, or persistent physical disability: 21.5 versus 21.2 events per 1000 person-years; HR 1.01 (95% CI 0.92-1.11; P=0.79).
  • Secondary individual components (death from any cause, dementia, persistent physical disability) were not substantially different. Death from any cause was 12.7 versus 11.1 events per 1000 person-years.
  • Major hemorrhage was higher with aspirin: 3.8% versus 2.8%; HR 1.38 (95% CI 1.18-1.62; P<0.001).

Harms

  • Major hemorrhage was higher with aspirin (3.8% versus 2.8%; HR 1.38; 95% CI 1.18-1.62; P<0.001).

Clinical Use

Practice impact

  • Do not start 100 mg aspirin in healthy older adults to prolong disability-free survival.
  • This is not a secondary-prevention trial.

Applicability

  • Community-dwelling older adults without cardiovascular disease, dementia, or physical disability, as enrolled in Australia and the United States.

Limitations

  • The trial was stopped at a median of 4.7 years after a determination of no primary-end-point benefit with continued aspirin.
  • Adherence in the final year of participation was 62.1% with aspirin and 64.1% with placebo.
  • The trial excluded people with known cardiovascular disease, dementia, or physical disability.

Common misinterpretations

  • This paper's primary result is disability-free survival, not a cardiovascular-event comparison.
  • The primary interval included no effect (HR 1.01; 95% CI 0.92-1.11); aspirin did not prolong disability-free life.
  • Death, dementia, and persistent disability taken separately were not substantially different.
  • These data do not apply to aspirin for secondary prevention after established cardiovascular disease.

Related evidence

JUPITER - ContextHOPE - Context

Citation

McNeil JJ, Woods RL, Nelson MR, et al. Effect of Aspirin on Disability-free Survival in the Healthy Elderly. N Engl J Med. 2018;379(16):1499-1508. doi:10.1056/NEJMoa1800722

Aspirin use in healthy elderly persons did not prolong disability-free survival over a period of 5 years but led to a higher rate of major hemorrhage than placebo.