Aspirin to Reduce Risk of Initial Vascular Events - ARRIVE

Contribution To Literature:

The ARRIVE trial failed to show that aspirin was superior to placebo at preventing adverse cardiovascular events among moderate-risk patients.


The goal of the trial was to evaluate aspirin compared with placebo among patients with moderate risk of cardiovascular disease (10-year risk of coronary heart disease 10-20%).

Study Design

  • Randomized
  • Parallel
  • Blinded
  • Placebo

Patients at moderate risk of coronary heart disease were randomized to aspirin 100 mg daily (n = 6,270) versus placebo (n = 6,276).

  • Total number of enrollees: 12,546
  • Duration of follow-up: median 60 months
  • Mean patient age: 64 years
  • Percentage female: 30%

Inclusion criteria:

  • Patients ≥55 years (men) or ≥60 years (women)
  • ≥3 cardiovascular risk factors (dyslipidemia, current smoking, high blood pressure, positive family history of cardiovascular disease)

Exclusion criteria:

  • Diabetes
  • History of stroke, myocardial infarction, coronary revascularization, vascular intervention, significant arrhythmia, or congestive heart failure
  • Use of antiplatelet therapy, anticoagulation therapy, or nonsteroidal anti-inflammatory drugs
  • History of gastric or duodenal ulcer or gastrointestinal bleeding

Other salient features/characteristics:

  • Estimated baseline 10-year risk of cardiovascular disease: 17%

Principal Findings:

The primary efficacy outcome, cardiovascular death, myocardial infarction, unstable angina, stroke, or transient ischemic attack, occurred in 4.3% of the aspirin group compared with 4.5% of the placebo group (p = 0.60).

The primary safety outcome, gastrointestinal bleeding, was 0.97% of patients in the aspirin group versus 0.46% in the placebo group (p = 0.0007).

Secondary outcomes:

  • Myocardial infarction: 1.4% with aspirin vs. 1.6% with placebo (p = 0.84)
  • Stroke: 1.2% with aspirin vs. 1.1% with placebo (p = 0.51)


Among patients at moderate risk of coronary heart disease, the use of aspirin was not beneficial. Aspirin was not associated with a reduction in adverse cardiovascular events. Bleeding events were low and similar between treatment arms. A significant limitation of this trial was the lower than expected event rate. The use of aspirin in moderate-risk patients needs to be individualized.


Gaziano JM, Brotons C, Coppolecchia R, et al., on behalf of the ARRIVE Executive Committee. 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;Aug 26:[Epub ahead of print].

Presented by Dr. J. Michael Gaziano at the European Society of Cardiology Congress, Munich, Germany, August 26, 2018.

Clinical Topics: Anticoagulation Management, Diabetes and Cardiometabolic Disease, Dyslipidemia, Prevention, Smoking

Keywords: ESC Congress, ESC18, Angina, Unstable, Anticoagulants, Aspirin, Blood Pressure, Coronary Disease, Dyslipidemias, Hemorrhage, Ischemic Attack, Transient, Myocardial Infarction, Primary Prevention, Risk, Smoking, Stroke, Vascular Diseases

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