Effect of Aspirin on Disability-free Survival in the Healthy Elderly
By McNeil et al.
N Engl J Med 2018;379:1499-508
https://www.nejm.org/doi/pdf/10.1056/NEJMoa1800722
During my rotations, I have noticed many geriatric patients placed on Aspirin. From my first LTC site evaluation H&P presentation, my patient with a past medical history of hypertension and hyperlipidemia was taking aspirin. I assumed that it was for cardiovascular disease prevention, but I listed the indication under “Hypertension”. My site evaluator challenged me to consider its actual indication, and to consider the guidelines for low dose aspirin in older women. When doing the research, I came across multiple articles that referred to the “ASPEE trial,” which stands for “Aspirin in Reducing Events in the Elderly”. I decided to find this article to understand what the trial was about.
The study described how often patients with a history of stroke or coronary disease would be told to take low dose aspirin to prevent cardiovascular disease. On the other hand, the benefits versus risk of taking aspirin in those patients with no history of stroke or coronary disease, has not been widely studied. ASPREE recruited healthy subjects with no history of cardiovascular or cerebrovascular disease, chronic diseases that may cause death within 5 years, dementia, high risk of bleed, nor significant physical disability. Inclusion ages were 65 years and older in Hispanics and blacks (due to these population’s higher risk for CV disease or dementia) and 70 years in other populations. The subjects were from the United States and Australia, with recruitment methods ranging from medical providers’ identification of patients, clinic mailing lists, screening EMRs, or placed advertisements; with subsequent letters of invitation. The study was double-blind, and randomized in which patients would be taking 100mg of aspirin (total 9525 subjects) or a placebo (total 9589 subjects). Participants would be reached via phone calls every 3-6 months to check adherence to the study intervention, and to assess whether they reached the “end point” to this study. This end point was defined as having outcomes of “disability-free survival” where the patient does not have dementia nor physical disability, or the composite outcomes of death, dementia, physical disability, cardiovascular disease, cancer, depression, or hemorrhage.
This study lasted for roughly 4.7 years until the researchers found that continuing the study would not yield a significant treatment effect. They found that the aspirin group did not have a significant difference in “disability-free survival” compared with the placebo group. In comparing rates of death, dementia, or physical disability, the aspirin group had “21.5 events per 1000 person-years in the aspirin group and 21.2 per 1000 person-years in the placebo group”. The incidence of major hemorrhage was higher at 3.8% in the aspirin group, compared with the 2.8% in the placebo group. This outcome is similar to other studies who included slightly younger subjects compared with this trial, finding no significant cardiovascular effect in the aspirin group, but a higher bleeding risk.
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