ASCEND (aspirin)
Trial question
What is the effect of aspirin for the prevention of first cardiovascular events in adult diabetic patients?
Study design
Multi-center
Single blinded
RCT
Population
Characteristics of study participants
37.0% female
63.0% male
N = 15480
15480 patients (5796 female, 9684 male)
Inclusion criteria: adult diabetic patients with no evident CVD
Key exclusion criteria: clear indication for aspirin; contraindication to aspirin; known CVD; presence of other clinically significant conditions that might limit adherence to the trial regimen for at least 5 years
Interventions
N=7740 aspirin (100 mg PO once daily)
N=7740 placebo (matching oral tablet once daily)
Primary outcome
Rate of serious vascular events at a mean follow-up of 7.4 years
8.5
9.6
9.6 %
7.2 %
4.8 %
2.4 %
0.0 %
Aspirin
Placebo
Significant decrease ▼
NNT = 90
Significant decrease in the rate of serious vascular events at a mean follow-up of 7.4 years (8.5% vs. 9.6%; RR 0.88, 95% CI 0.79 to 0.97)
Secondary outcomes
Significant increase in major bleeding events (4.1% vs. 3.2%; RR 1.29, 95% CI 1.09 to 1.52)
Safety outcomes
No significant differences in gastrointestinal tract cancer, any cancers excluding nonfatal nonmelanoma skin cancer.
Conclusion
In adult diabetic patients with no evident CVD, aspirin was superior to placebo with respect to the rate of serious vascular events at a mean follow-up of 7.4 years.
Reference
ASCEND Study Collaborative Group, Bowman L, Mafham M et al. Effects of Aspirin for Primary Prevention in Persons with Diabetes Mellitus. N Engl J Med. 2018 Oct 18;379(16):1529-1539.
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