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Benefit of aspirin for primary prevention of cardiovascular events remains unclear: ARRIVE trial results

ESC Congress News 2018 - Munich, Germany

Once-daily aspirin failed to reduce the rate of primary cardiovascular events in patients with no known cardiovascular disease and moderate cardiovascular risk, reports Professor J Michael Gaziano (Brigham and Women’s Hospital, Boston, Massachusetts, USA) in a Hot Line session yesterday, with simultaneous publication in The Lancet (1).

Risk Factors and Prevention
Cardiovascular Pharmacotherapy

arrive.jpgThe ARRIVE trial involved 12,546 participants with an estimated 10-year cardiovascular disease risk of 20–30% and is the first large randomised controlled trial to explore the efficacy and safety of primary prophylactic aspirin in this particular population. Participants received either once-daily enteric-coated aspirin 100 mg or placebo. Median follow-up was 60 months and the primary endpoint was time to first occurrence of a composite of cardiovascular death, myocardial infarction (MI), stroke, unstable angina and transient ischaemic attack.

In the intention-to-treat analysis, a primary cardiovascular event occurred in 4.29% of participants allocated daily aspirin vs 4.48% of participants allocated placebo (hazard ratio [HR] 0.96; 95% confidence intervals [CI] 0.81–1.13; p=0.60).

However, there was an unexpectedly low number of cardiovascular events that occurred overall. “The event rate was more in line with what we would expect to see in a population at low risk of cardiovascular events,” says Prof. Gaziano. “This may have been because some participants were taking medications to lower blood pressure and lipids, which protected them from disease,” he adds.

There were considerably fewer events than anticipated (550 participants had a primary endpoint event versus the 1,488 expected), which may have impacted the findings.

The risk of total and non-fatal MI (HR 0.53; 95% CI 0.36–0.79; p=0.0014 and HR 0.55; 95% CI 0.36–0.84; p=0.0056, respectively) was reduced by aspirin in the per-protocol analysis, and the relative risk reduction of MI in the aspirin group was 82.1% for those aged 50–59 years.

“Those who took aspirin tended to have fewer heart attacks, but there was no effect on stroke. As expected, the rate of gastrointestinal bleeding was higher in the aspirin group, but there was no difference in fatal bleeding events between groups,” reports Prof. Gaziano.

Although mostly mild, gastrointestinal bleeds occurred twice as often in the aspirin group than the placebo group (0.97% vs 0.46%, respectively; HR 2.11; 95% CI 1.36–3.28; p=0.0007).

“The use of aspirin remains a decision that should involve a thoughtful discussion between a clinician and a patient given the need to weigh the cardiovascular and cancer benefits against the bleeding risks, patient preferences, cost and other factors,” concludes Prof. Gaziano.

1. Gaziano JM, et al. Lancet 2018; August 26:


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Notes to editor

About the European Society of Cardiology

The European Society of Cardiology brings together healthcare professionals from more than 150 countries, working to advance cardiovascular medicine and help people lead longer, healthier lives.

About ESC Congress 2018

ESC Congress is the world’s largest and most influential cardiovascular event contributing to global awareness of the latest clinical trials and breakthrough discoveries. ESC Congress 2018 takes place 25 to 29 August at the Messe München in Munich, Germany. Explore the scientific programme