Findings from the ASPREE study presented Aug. 31 at ESC Congress 2019 suggest that any benefits associated with a risk-based approach to the use of aspirin for primary prevention in a healthy elderly population are outweighed by major bleeding risks.

The study, conducted by Christopher M. Reid, MD, et al., randomized 19,114 men and women from Australia (16,703) and the U.S. (2,411) to either 100 mg enteric-coated aspirin or placebo. U.S. recruitment placed heavy emphasis on black and Hispanic participants aged >65 years. Median follow-up was 4.8 years. The primary endpoint was prolongation of disability-free life and the secondary outcome was all-cause mortality.

Overall results found that the cumulative incidence of cardiovascular disease was slightly greater in patients with placebo vs. aspirin starting around year three post-randomization. The cumulative incidence of major hemorrhage was greater in the aspirin group vs. placebo from the time of randomization and throughout the follow-up period. To determine whether the baseline levels of cardiovascular risk influenced the effects of aspirin on disability-free survival, cardiovascular events and major bleeding, researchers used the Framingham Modified Risk Equation and the ACC/AHA ASCVD Pooled Risk Equation. For patients over 80, who fell outside the Framingham and ASCVD risk equations, researchers assessed risk on the basis of presence of multiple conventional cardiovascular risk factors, including gender, hypercholesterolemia, current smoking, diabetes, obesity and reduced renal function.

"As a population strategy the findings do not support aspirin for primary prevention in the elderly," said Reid and colleagues. The also noted that clustering of conventional risk factors in patients over 80 did not identify a high cardiovascular disease risk group. The lack of suitable risk prediction equations for these patients was one of the limitations to the study, they said.

Keywords: ESC 19, ESC Congress, Aspirin, Risk Factors, Primary Prevention

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