ARRIVE (aspirin)
Trial question
What is the role of aspirin in the primary prevention of cardiovascular events in patients at moderate risk of CVD?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
30.0% female
70.0% male
N = 12546
12546 patients (3703 female, 8838 male)
Inclusion criteria: patients with a moderate estimated risk of a first cardiovascular event
Key exclusion criteria: high risk of gastrointestinal bleeding or other bleeding, diabetes, history of a vascular event, such as stroke, myocardial infarction, coronary artery angioplasty or stenting, CABG, congestive HF, or vascular intervention
Interventions
N=6270 aspirin (100 mg PO once daily daily)
N=6276 placebo (matching tablet once daily)
Primary outcome
Myocardial infarction, stroke, cardiovascular death, unstable angina, or transient ischemic attack
4.29
4.48
4.5 %
3.4 %
2.2 %
1.1 %
0.0 %
Aspirin
Placebo
No significant difference ↔
No significant difference in myocardial infarction, stroke, cardiovascular death, unstable angina, or TIA (4.29% vs. 4.48%; HR 0.96, 96% CI 0.81 to 1.13)
Secondary outcomes
No significant difference in fatal or nonfatal myocardial infarction in the intention-to-treat population (1.52% vs. 1.78%; HR 0.85, 95% CI 0.64 to 1.11)
No significant difference in in the intention-to-treat population, nonfatal myocardial infarction (1.4% vs. 1.56%; HR 0.9, 95% CI 0.67 to 1.2)
No significant difference in death, in the intention-to-treat population (2.55% vs. 2.57%; HR 0.99, 99% CI 0.8 to 1.24)
Safety outcomes
No significant difference in overall adverse events (82.01% vs. 81.72%).
Significant differences in overall incidence of treatment-related adverse events (16.75% vs. 13.54%, p<0.0001), and gastrointestinal bleeding events (0.97% vs. 0.46%, p = 0.0007).
Conclusion
In patients with a moderate estimated risk of a first cardiovascular event, aspirin was not superior to placebo with respect to myocardial infarction, stroke, cardiovascular death, unstable angina, or TIA.
Reference
Gaziano JM, Brotons C, Coppolecchia R et al. Use of aspirin to reduce risk of initial vascular events in patients at moderate risk of cardiovascular disease (ARRIVE): a randomised, double-blind, placebo-controlled trial. Lancet. 2018 Sep 22;392(10152):1036-1046.
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