In older adults without cardiovascular disease, dementia, or disability, the use of low-dose aspirin as a primary prevention strategy may result in a "significantly higher risk" of major hemorrhage and not a "significantly lower risk" of cardiovascular disease when compared to placebo, according to results of the ASPREE trial published Sept. 16 in the New England Journal of Medicine.

John J. McNeil, MB, BS, PhD, et al., looked at 19,114 men and women in Australia and the U.S. who were 70 years of age or older and did not have cardiovascular disease, dementia, or disability. 9,525 participants were randomly assigned to receive 100 mg of aspirin, vs. 9,589 who were assigned to placebo.

Results showed that after a median of 4.7 years of follow-up, the rate of cardiovascular disease was 10.7 events per 1,000 person-years in the aspirin group vs. 11.3 events per 1,000 person-years in the placebo group (hazard ratio, 0.95; 95 percent confidence interval [CI], 0.83 to 1.08). The rate of major hemorrhage was 8.6 events per 1000 person-years vs. 6.2 events per 1000 person-years, respectively (hazard ratio, 1.38; 95 percent CI, 1.18 to 1.62; P<0.001).

The authors conclude that their results are similar "with the results of a recent meta-analysis of eight primary prevention trials." They add that "current guidelines in the U.S., Europe, and Australia have noted that there is limited evidence regarding the use of aspirin for primary prevention of cardiovascular disease in the elderly."

"While millions of individuals use aspirin for primary prevention, this routine practice is now questioned in light of recent randomized trial data," commented Anthony A. Bavry, MD, MPH, FACC, in a Trial Summary article on ACC.org. "However, this trial in no way should lesson our use of aspirin for secondary prevention," adds Kim A. Eagle, MD, MACC, editor-in-chief of ACC.org. "There are likely patients with high 10-year cardiovascular risk (e.g., greater than 10 percent event rate) and correspondingly low bleeding risk where use of low-dose aspirin still is beneficial for primary prevention."

Clinical Topics: Prevention, Sleep Apnea

Keywords: Aspirin, Follow-Up Studies, Primary Prevention, Cardiovascular Diseases, Risk, Hemorrhage, Dementia

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