McNeil JJ, et al. - Given that aspirin is a well-established therapy for the secondary prevention of cardiovascular events, researchers investigated its role in the primary prevention of cardiovascular disease (CVD), particularly in older individuals, who are at increased risk. Findings indicated that the use of low-dose aspirin brought about an altogether higher risk of major hemorrhage and did not result in a significantly lower risk of CVD vs placebo in this randomized trial involving healthy elderly individuals who did not have known CVD.

Methods

• From 2010 through 2014, researchers enrolled 19,114 community-dwelling men and women in Australia and the United States (US) aged ≥ 70 years (or aged ≥65 years among black and Hispanic individuals in the US) who did not have CVD (defined as fatal coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal stroke, or hospitalization for heart failure), dementia, or disability.
• Study participants were randomized to receive once-daily 100-mg enteric-coated aspirin (n=9,525) or placebo (n=9,589) orally.
• A composite of death, dementia, or persistent physical disability was assessed as the primary end point.
• Major hemorrhage and CVD were the included secondary end points.

Results

• The rate of CVD was found to be 10.7 events/1,000 person-years (PYs) in the aspirin group and 11.3 events/1,000 PYs in the placebo group (hazard ratio [HR]: 0.95; 95% confidence interval [CI]: 0.83-1.08) after a median of 4.7 years of follow-up.
• Findings revealed that the rate of major hemorrhage was 8.6 events/1,000 PYs and 6.2 events/1,000 PYs, respectively (HR: 1.38; 95% CI: 1.18-1.62; P < 0.001).