TOPLINE:
In patients with cryptogenic stroke and evidence of atrial cardiopathy without atrial fibrillation, results of the ARCADIA trial show that apixaban did not significantly reduce recurrent stroke risk compared with aspirin.
METHODOLOGY:
- The trial enrolled patients with cryptogenic stroke and evidence suggestive of atrial cardiopathy, but no evidence of atrial fibrillation, who were randomized to apixaban, 5 mg or 2.5 mg twice daily, or aspirin, 81 mg once daily.
- The primary efficacy outcome in a time-to-event analysis was recurrent stroke. The primary safety outcomes were symptomatic intracranial hemorrhage and other major hemorrhages.
TAKEAWAY:
- The trial was stopped because of futility after 1015 of the planned 1100 patients had been enrolled with a mean follow-up of 1.8 years.
- Recurrent stroke occurred at an annualized rate of 4.4% in both groups (hazard ratio, 1.00).
- Symptomatic intracranial hemorrhage did not occur in patients taking apixaban and seven taking aspirin (annualized rate, 1.1%). Other major hemorrhages occurred in five patients taking apixaban (annualized rate, 0.7%) and five taking aspirin (annualized rate, 0.8%).
IN PRACTICE:
In an accompanying editorial, Gregory M. Marcus, MD, and Bruce Ovbiagele, MD, from the University of California, San Francisco, point out that this was a study with an active control, aspirin, and "it would be a mistake to assume these data suggest that apixaban does nothing to prevent stroke among individuals with cryptogenic stroke and evidence of atrial cardiopathy."
Noting the higher numerical rates of intracranial hemorrhage with aspirin, they ponder whether it might be reasonable to consider apixaban as the preferred therapy. However, they conclude that the lack of statistical significance and the substantial cost differences do not support this recommendation at the current time.
SOURCE:
The study, led by Hooman Kamel, MD, Weill Cornell Medicine, New York City, was published online in JAMA on February 7.
LIMITATIONS:
Amid the COVID-19 pandemic, there was a higher-than-expected rate of withdrawal from the study. Few patients met the atrial cardiopathy criterion of severe left atrial enlargement, so the benefit of anticoagulation in such patients remains unknown.
DISCLOSURES:
The ARCADIA trial was funded by the US National Institutes of Health.