Daily Aspirin Regimen Raises Hemorrhage Risk in Elderly

Participants were randomly assigned to receive 100 mg of enteric-coated aspirin (9,525 people) or placebo (9,589). The primary end point was a composite of death, dementia, or persistent physical disability. Secondary end points included major hemorrhage and CVD.

The results revealed that after a median of 4.7 years of follow-up, the rate of CVD--defined as fatal coronary heart disease, nonfatal myocardial infarction (MI), fatal or nonfatal stroke, or hospitalization for heart failure--was 10.7 events per 1,000 person-years in the aspirin group, and 11.3 events per 1,000 person-years in the placebo group. The rate of major hemorrhage was 8.6 events per 1,000 person-years and 6.2 events per 1,000 person-years, respectively, or 38% higher. The study was published on September 16, 2018, in the New England Journal of Medicine (NEJM).

“The take-home message of such a complex, large, placebo-controlled study is that healthy older people contemplating how best to preserve their health will be unlikely to benefit from aspirin,” said lead author Professor John McNeil, PhD, director of the Monash University department of epidemiology and preventive medicine. “It means millions of healthy older people around the world who are taking low-dose aspirin without a medical reason may be doing so unnecessarily, because the study showed no overall benefit to offset the risk of bleeding.”

Low-dose aspirin is among the most widely used agents for the prevention of CVD. Its efficacy has been established in secondary prevention trials, in which the benefits associated with reducing the rates of both MI and ischemic stroke appear to outweigh the risk of hemorrhage. But the role of low-dose aspirin as a primary prevention strategy remains debated. In elderly populations, the risk of CVD is higher and the potential benefits of aspirin may accordingly be greater than in younger populations; however, an increased risk of bleeding has also been observed in the elderly age group.

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