The use of aspirin in diabetes patients reduced the risk of occlusive vascular events by 12% but its benefits were canceled by the increased risk of unwanted bleeding by 29%, according to the findings of the ASCEND trial.
The findings were presented at the European Society of Cardiology (ESC) 2018 Congress and subsequently published in the New England Journal of Medicine (NEJM).
Diabetes mellitus is associated with an increased risk of cardiovascular events. Jane Armitage, professor of clinical trials and epidemiology and honorary consultant in public health medicine at the University of Oxford, and colleagues conducted the study to determine the benefits and hazards of aspirin for the prevention of first cardiovascular events in diabetes patients.
A total of 15,480 adults having diabetes but no evident cardiovascular disease were randomly assigned to receive aspirin at a dose of 100 mg daily or matching placebo.
The primary efficacy outcome was the first serious vascular event (i.e., myocardial infarction, stroke or transient ischemic attack, or death from any vascular cause, excluding any confirmed intracranial hemorrhage). The primary safety outcome was the first major bleeding event (i.e., intracranial hemorrhage, a sight-threatening bleeding event in the eye, gastrointestinal bleeding, or other serious bleeding). Secondary outcomes included gastrointestinal tract cancer.
- During a mean follow-up of 7.4 years, serious vascular events occurred in a significantly lower percentage of participants in the aspirin group than in the placebo group (658 participants [8.5%] vs. 743 [9.6%])
- Major bleeding events occurred in 314 participants (4.1%) in the aspirin group, as compared with 245 (3.2%) in the placebo group with most of the excess being gastrointestinal bleeding and other extracranial bleeding.
- There was no significant difference between the aspirin group and the placebo group in the incidence of gastrointestinal tract cancer (157 participants [2.0%] and 158 [2.0%], respectively) or all cancers (897 [11.6%] and 887 [11.5%]); long-term follow-up for these outcomes is planned.
“Our results demonstrate that aspirin use prevented serious vascular events in persons who had diabetes and no evident cardiovascular disease at trial entry, but it also caused major bleeding events. The absolute benefits were largely counterbalanced by the bleeding hazard,” concluded the authors.
For further information log on to 10.1056/NEJMoa1804988