ARRIVE: New Findings Contribute to Growing Body of Evidence Surrounding Aspirin Use

Findings from the ARRIVE study presented Aug. 26 at ESC Congress 2018 and published in The Lancet add additional data to the body of evidence that can help clinicians decide when to use aspirin with their patients.

ARRIVE – a multi-center study done in seven countries – randomized 12,546 patients to receive either aspirin (100 mg; N=6,270) or placebo (N=6,276). Patients were aged 55 years (men) and 60 years (women) or older and at average cardiovascular risk based on specific risk factors. Those at high risk of bleeding or diabetes were excluded. Median follow-up was 60 months. The primary endpoint was a composite outcome of time to first occurrence of cardiovascular death, myocardial infarction, unstable angina, stroke, or transient ischemic attack. Researchers also assessed hemorrhagic events and incidence of other adverse events.

Overall, the primary endpoint occurred in 269 patients in the aspirin group compared with 281 patients in the placebo group. Gastrointestinal events occurred in 0.97 percent of patients in the aspirin group vs. 0.46 percent in the placebo group. The overall incidence rate of serious adverse events was similar in both treatment groups (20.19 percent in aspirin group vs. 20.89 percent in placebo group). Researchers did note a lower risk of myocardial infarction among patients taking aspirin compared with those taking placebo, although the difference was not significant.

According to study investigators, ARRIVE's findings regarding aspirin's effects are consistent with those observed in previously published low-risk primary prevention studies. They also point out that "ARRIVE provides valuable lessons about the challenges of carrying out large-scale primary prevention studies when there are multiple widely available preventive and therapeutic interventions, resulting in lower observed cardiovascular risk than expected."

"The ARRIVE data must be interpreted in the context of other studies, which have tended to demonstrate a reduction primarily in myocardial infarction, but less of an effect on total stroke (including both ischemic and hemorrhagic stroke)," they said. "The overall decision to use aspirin should be based on individual patient–physician discussion."

Keywords: ESC18, ESC Congress, Acute Coronary Syndrome, Aspirin, Risk, Primary Prevention, Secondary Prevention

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