Key result
Daily 100 mg aspirin shows no benefit over placebo for the primary composite outcome.
Why the study?
The long-term and legacy effects of daily low-dose aspirin for primary prevention in older adults without cardiovascular disease and significant disability require further evaluation.
What are the long-term and legacy effects of daily 100mg aspirin on death, dementia, disability, CVD events, bleeding, and cancer in older individuals for primary prevention?
What are the long-term and legacy effects of daily 100mg aspirin on death, dementia, disability, CVD events, bleeding, and cancer in older individuals for primary prevention?
Hazard Ratio: 1.01 (95% CI 0.92–1.11)
This paper outlines the statistical analysis plan for the ASPREE-XT observational follow-up study to evaluate the long-term and legacy effects of aspirin in older adults.
No benefit on primary endpoint in older adults; reinforces avoiding aspirin for primary prevention while extending follow-up to assess legacy effects.
The ASPREE randomized controlled trial (2010-2017) of 19,114 community-dwelling older adults without cardiovascular disease and significant disability compared daily 100mg aspirin to placebo. A total of 16,317 (93%) of 17,546 surviving and non-withdrawn participants agreed to continue regular study follow-up visits in the post-trial phase, named ASPREE-XT (2017-2024). We present a statistical analysis plan to underpin three main papers to report aspirin effects through to the fourth post-trial ASPREE-XT study visit with focus areas of: (1) death, dementia, and disability, (2) CVD events and bleeding, and (3) cancer. The focus of the plan is to estimate long-term (entire timespan of RCT plus post-trial) and legacy (post-trial period only) effects of aspirin in the setting of primary prevention for older individuals. Preliminary insights to these effects are presented that are based on data that has been reported to the study's observational study monitoring board however formal data lock is not expected until October 2023.
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Wolfe et al. (2023) studied Primary prevention of cardiovascular disease and disability (n=19,114). Aspirin vs. Placebo was evaluated on Primary endpoint (HR 1.01, 95% CI 0.92, 1.11). Daily 100mg aspirin did not significantly affect the primary endpoint compared to placebo during the randomized trial phase (HR 1.01) or in preliminary unadjusted post-trial analyses (HR 1.05).
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