Clinician Article
Effect of Aspirin on Cardiovascular Events and Bleeding in the Healthy Elderly.
PMID: 30221597
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CardiologyRelevance - 7/7
Newsworthiness - 7/7 -
Public HealthRelevance - 7/7
Newsworthiness - 7/7 -
GeriatricsRelevance - 7/7
Newsworthiness - 6/7 -
Internal MedicineRelevance - 7/7
Newsworthiness - 6/7 -
Family Medicine (FM)/General Practice (GP)Relevance - 6/7
Newsworthiness - 6/7 -
General Internal Medicine-Primary Care(US)Relevance - 6/7
Newsworthiness - 6/7
Abstract
BACKGROUND: Aspirin is a well-established therapy for the secondary prevention of cardiovascular events. However, its role in the primary prevention of cardiovascular disease is unclear, especially in older persons, who have an increased risk.
METHODS: From 2010 through 2014, we enrolled community-dwelling men and women in Australia and the United States who were 70 years of age or older (or =65 years of age among blacks and Hispanics in the United States) and did not have cardiovascular disease, dementia, or disability. Participants were randomly assigned to receive 100 mg of enteric-coated aspirin or placebo. The primary end point was a composite of death, dementia, or persistent physical disability; results for this end point are reported in another article in the Journal. Secondary end points included major hemorrhage and cardiovascular disease (defined as fatal coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal stroke, or hospitalization for heart failure).
RESULTS: Of the 19,114 persons who were enrolled in the trial, 9525 were assigned to receive aspirin and 9589 to receive placebo. After a median of 4.7 years of follow-up, the rate of cardiovascular disease was 10.7 events per 1000 person-years in the aspirin group and 11.3 events per 1000 person-years in the placebo group (hazard ratio, 0.95; 95% confidence interval [CI], 0.83 to 1.08). The rate of major hemorrhage was 8.6 events per 1000 person-years and 6.2 events per 1000 person-years, respectively (hazard ratio, 1.38; 95% CI, 1.18 to 1.62; P<0.001).
CONCLUSIONS: The use of low-dose aspirin as a primary prevention strategy in older adults resulted in a significantly higher risk of major hemorrhage and did not result in a significantly lower risk of cardiovascular disease than placebo. (Funded by the National Institute on Aging and others; ASPREE ClinicalTrials.gov number, NCT01038583 .).
Clinical Comments
General Internal Medicine-Primary Care(US)
This study should not be used to say that ASA is not helpful in all patients. These patients were elderly without CV disease suggesting they were healthy and at lower risk. The table confirms this with a low percentage of patients who were obese, smokers, and had diabetes. Also, 65% had HLP but only 34% were on statins. Would it be helpful in younger patients who have longer life to develop events or in those at higher risk of CV disease? The short follow-up and small number of events introduce bias. This may be inferred from Fig 1 showing event divergence after yr 5 and the near significant difference in MACE. Since most of the adverse events were GIB and a small percentage were on acid suppression, these events could have been prevented leading to potential net benefit. As noted by the authors, poor compliance also could affect potential net benefit.
General Internal Medicine-Primary Care(US)
To me, this study is practice-changing. I have already talked to a couple patients about this study and changed my primary prevention recommendations.
Geriatrics
Findings are not surprising as it is not easy to lower risk in people who begin with a low risk. Having said that, there is no need to panic for high-risk patients who may need and may benefit from aspirin. The relative risk for major bleeding was 38% higher in the aspirin (vs non-aspirin) group (HR, 1.38; 95% CI, 1.18 to 1.62; P<0.001). At the rates of 6.2 events/1000 person-years, if 1000 adults >=70 years did not take aspirin for 20 years, then there would be 124 events. Life expectancy at age 70 in Australia is < 20 years. The 20-year rate for 1000 patients taking aspirin would be 176 events. Thus, if 1000 older adults >=70 years took aspirin for the rest of their lives, there will be 52 extra events of major bleeding (a third would be intracranial). While any avoidable adverse outcome is desirable, 95% of adults >=70 years taking aspirin would live the rest of their lives as if they had not taken aspirin.
Internal Medicine
For the standard new media, this seems to be big news. It is of limited value to clinicians dealing with other than healthy populations. I think the new media needs to emphasize that more.
Public Health
Large, well done RCT that excludes a large benefit for aspirin in primary prevention in the elderly. It also demonstrates that a significant bleeding risk does occur even with low-dose aspirin. The search for the magic elixir for CVD prevention continues.
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