6/28/23, 12:44 AM ARRIVE (aspirin) Pathway Feedback Search Clinical Topics Home Studies ARRIVE (aspirin) ARRIVE (aspirin) Disease Disease Disease Acute ischemic stroke Non-ST-elevation myocardial inf ST-elevat 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 N = 12546 70.0% male 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, coronary artery bypass graft, congestive HF, or vascular intervention Interventions N=6270 aspirin (100 mg PO once daily daily) N=6276 placebo (matching tablet once daily) Primary outcome https://web.pathway.md/studies/recCbUafZfWtiBOCn 1/2 6/28/23, 12:44 AM ARRIVE (aspirin) Pathway Myocardial infarction, stroke, cardiovascular death, unstable angina, or transient ischemic attack 4.5 % 4.48 4.29 3.4 % 2.2 % 1.1 % No significant difference 0.0 % Aspirin Placebo 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. Open reference URL https://web.pathway.md/studies/recCbUafZfWtiBOCn 2/2