HealthDay News — A once daily oral dose of rivaroxaban (Xarelto) significantly lowers the risk for intracranial hemorrhage (ICH) in patients with atrial fibrillation (AF) who are at moderate to high risk for stroke, according to data presented at the American Heart Association’s 2012 International Stroke Conference in New Orleans.
Although oral anticoagulation can reduce the risk of ischemic stroke in AF patients, these therapies may also offset the intended benefits in certain individuals at high risk for hemorrhagic stroke.
In order to better understand which patients with AF are at high risk for hemorrhagic stroke, Graeme J. Hankey, MBBS, MD, of the Royal Perth Hospital in Australia, and colleagues randomly assigned 14,264 patients with nonvalvular AF to rivaroxaban or dose-adjusted warfarin, and followed participants for a median of 1.94 years.
During the study period, 136 patients experienced intracerebral hemorrhagic (ICH) events at an average annual rate of 0.55 per 100 patient years, the researchers found. These included intracerebral hemorrhage (n=98), subarachnoid hemorrhage (n=5), subdural hemorrhage (n=32) and extradural hemorrhage (n=1).
Several significant independent predictors of increased risk for ICH were identified: increased age, previous stroke or transient ischemic attack, black or Asian race, decreasing serum albumin and decreased platelet count below 210 × 109/l. After adjusting for potential confounding 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, whereas rivaroxaban was protective compared with warfarin.
Several researchers disclosed financial ties to pharmaceutical companies, including Johnson & Johnson and Bayer HealthCare, which funded the study and jointly developed rivaroxaban.