EXTENDED follow-up results from the ASPREE trial have shown that older adults who are prescribed daily low-dose aspirin for primary prevention do not show long-term reductions in major cardiovascular events, and face an increased risk of serious bleeding. These findings highlight the need for caution when considering aspirin in individuals without prior cardiovascular disease.
Low-dose aspirin is often used as a preventive measure against atherosclerotic cardiovascular events. Recent guidelines, however, advise against routine use in older adults who are free of cardiovascular disease, due to uncertainty about long-term benefits and greater potential for harm. The ASPREE trial and its extended follow-up sought to clarify the real-world impact of prolonged aspirin use in healthy seniors.
Researchers analysed outcomes from 19,114 participants, randomised to receive daily aspirin or placebo between 2010 and 2017, with ongoing monitoring until 2022. Individuals were aged at least 70, or 65 for US minorities, and excluded if they had a history of cardiovascular events, dementia or physical disabilities impacting independence. Of those enrolled, 15,668 continued into post-trial follow-up. Over the full monitoring period, aspirin did not reduce the incidence of major adverse cardiovascular events (MACE), with a hazard ratio of 1.04 (95 per cent confidence interval 0.94 to 1.15). During the post-trial phase, those assigned aspirin actually had a higher rate of cardiovascular events (hazard ratio 1.17, 95 per cent CI 1.01 to 1.36) compared to placebo. The risk of major bleeding was consistently greater among aspirin users throughout the study (hazard ratio 1.24, 95 per cent CI 1.10 to 1.39).
These results underline the importance of following current recommendations and avoiding routine aspirin use for primary prevention in older adults without established cardiovascular disease. In clinical practice, decisions to prescribe aspirin should carefully weigh individual patient risk and favour those with recognised benefit. Ongoing education for clinicians and patients is crucial, as is further research to understand any residual protective effects in specific high-risk groups.
Reference
Wolfe R et al. Aspirin, cardiovascular events, and major bleeding in older adults: extended follow-up of the ASPREE trial. European Heart Journal. 2025;ehaf514.
