(HealthDay News) – A once daily oral dose of rivaroxaban (Xarelto) significantly lowers the risk of intracranial hemorrhage (ICH) in patients with atrial fibrillation (AF) at moderate to high risk of stroke, according to a study presented at the American Heart Association’s International Stroke Conference, held from Feb. 1 to 3 in New Orleans.
Graeme J. Hankey, MBBS, MD, of the Royal Perth Hospital in Australia, and colleagues studied 14,264 patients with nonvalvular AF randomized to rivaroxaban or dose-adjusted warfarin. Participants were followed for a median of 1.94 years.
The researchers found that, over the study period, 136 patients experienced ICH events (intracerebral hemorrhage , subarachnoid hemorrhage , subdural hemorrhage , and extradural hemorrhage ), with an average annual rate of 0.55 per 100 patient-years. Increased age, previous stroke or transient ischemic attack, black or Asian race, decreasing serum albumin, and decreased platelet count below 210 × 109/L were identified as significant, independent predictors of increased risk for ICH. Adjusting for other variables, creatinine clearance was not associated with the occurrence of ICH (P=0.3181). Aspirin and thienopyridine use at baseline correlated with an increased risk of ICH, while rivaroxaban was protective compared to warfarin.
“Rivaroxaban was associated with a significantly lower risk of ICH compared with warfarin,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Johnson & Johnson and Bayer HealthCare, which funded the study and jointly developed rivaroxaban.