The ASCEND and ARRIVE trials -presented at the European Cardiology Congress and published in The New England Journal of Medicine (NEJM) and The Lancet respectively- have put against the ropes the indication of aspirin in the context of primary prevention.
The ASPREE trial, recently published in the NEJM, appears to have definitely overthrown aspirin, since it concludes that low doses of this drug as primary prevention strategy for elderly adults results in a significant increase of major bleeding, with no Benefit in terms of cardiovascular risk, compared against placebo.
However, its secondary prevention role remains intact.
The ASPREE recruited patients older than 70 (or ≥65 in case of African- American or Hispanics) with no history of cardiovascular disease, dementia or disability, between the years 2010 and 2014. Participants were randomized to 100 mg of enteric-coated aspirin or placebo. The primary end point was a composite of death, dementia, or persistent physical disability. Secondary end points included major bleeding or cardiovascular disease (defined as fatal coronary heart disease, nonfatal myocardial infarction, stroke, or hospitalization for heart failure).
Researchers looked at 19114 patients (9525 receiving aspirin vs 9589 receiving placebo) that, after a 4.7 year follow up, showed 10.7 cardiovascular event per 1000 persons/year in the aspirin group vs. 11.3 events per 1000 persons/year in the placebo group (HR 0.95). Major bleeding rate was 8.6 events per 1000 persons/year and 6.2 per 1000 persons/year in the placebo group (HR 1.38; p<0.0001).
Low doses of aspirin as primary prevention strategy in elderly adults increased major bleeding compared against placebo, with no significant reduction of cardiovascular disease.
Original title: Effect of Aspirin on Cardiovascular Events and Bleeding in the Healthy Elderly. for the ASPREE Investigator Group.
Reference: J.J. McNeil et al. N Engl J Med 2018;379:1509-18.
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