ASPREE: Primary Prevention with Low-dose Aspirin Doesn’t Reduce CV Risk

By DocWire News Editors - Last Updated: April 17, 2025

Daily low-dose aspirin was not associated with a reduced risk for cardiovascular disease (CVD) when used as a primary prevention strategy and was in fact linked with an increased risk for major hemorrhage, new results from the Aspirin in Reducing Events in the Elderly (ASPREE) study suggested.  

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The authors, publishing a series of aspirin studies in the New England Journal of Medicine, included an analysis of the long-term associated between daily aspirin use and cardiovascular risks, dementia, and physical disabilities. The cardiovascular analysis included 19,114 patients without cardiovascular disease, dementia, or physical disability, and randomized them to either 100 mg enteric-coated aspirin or to placebo. The primary endpoint was a composite of death, dementia, or persistent physical disability, which are reported in another NEJM article, but the study also included important secondary endpoints such as major hemorrhage and cardiovascular disease (defined as fatal coronary heart disease, nonfatal myocardial infarction, fatal or non-fatal stroke, or hospitalization for heart failure). The patients were followed for a mean of 4.7 years. 

The study results showed a cardiovascular disease rate of 1.7 events per 1,000 person-years in the aspirin group compared to 11.3 events per 1,000 person-years in the placebo group (HR=0.95; 95% CI, 0.83 to 1.08). The rate of major hemorrhage, however, was elevated, at 8.6 events per 1,000 person-years in the aspirin group compared to 6.2 events per 1,000 person-years for placebo (HR=1.38; 95% CI, 1.18 to 1.62; P<0.001). 

“This work is a key milestone in the more than a decade-long engagement in this large-scale clinical trial in the United States and Australia,” lead investigator Dr. Raj C. Shah, an associate professor of family medicine with the Rush Alzheimer’s Disease Center in Chicago, said in a press release. “The results will have a significant impact on guidelines about aspirin use for prevention and in daily clinical conversations between clinicians and their older, healthy patients regarding whether aspirin should or should not be used for achieving disability-free longevity.” 

https://twitter.com/MarcDweck/status/1041641516102569984

Source: New England Journal of Medicine

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