Compliance-adjusted analyses confirmed that 100 mg daily aspirin provided no benefit for disability-free survival in older persons, but increased the risk of clinically significant bleeding.
RCT (n=19,114)
randomized
Yes
Does aspirin 100 mg daily improve disability-free survival in older persons for primary prevention?
Compliance-adjusted analyses of the ASPREE trial confirm that aspirin provides no primary prevention benefit in older adults while increasing the risk of major bleeding and mortality.
The Aspirin in Reducing Events in the Elderly (ASPREE) Trial recruited 19,114 participants across Australia and the United States during 2010-2014. Participants were randomized to receive either 100 mg of aspirin daily or matching placebo, with disability-free survival as the primary outcome. During a median 4.7 years of follow-up, 37% of participants in the aspirin group permanently ceased taking their study medication and 10% commenced open-label aspirin use. In the placebo group, 35% and 11% ceased using study medication and commenced open-label aspirin use, respectively. In order to estimate compliance-adjusted effects of aspirin, we applied rank-preserving structural failure time models. The results for disability-free survival and most secondary endpoints were similar in intention-to-treat and compliance-adjusted analyses. For major hemorrhage, cancer mortality, and all-cause mortality, compliance-adjusted effects of aspirin indicated greater risks than were seen in intention-to-treat analyses. These findings were robust in a range of sensitivity analyses. In accordance with the original trial analyses, compliance-adjusted results showed an absence of benefit with aspirin for primary prevention in older people, along with an elevated risk of clinically significant bleeding.
Smith et al. (Tue,) conducted a rct in Primary prevention (n=19,114). Aspirin vs. matching placebo was evaluated on disability-free survival. Compliance-adjusted analyses confirmed that 100 mg daily aspirin provided no benefit for disability-free survival in older persons, but increased the risk of clinically significant bleeding.