What is the risk of intracranial and major non-intracranial bleeding when taking Rivaroxaban compared to Dabigatran?
A new-user Food and Drug Administration Medicare analysis of 118,891 patients found that rivaroxaban compared with dabigatran had a statistical trend toward a decreased risk of stroke (HR, 0.81; 95% CI, 0.65-1.01) and a significantly increased risk of intracranial (HR, 1.47; 95% CI, 1.32-1.67) and major non-intracranial (HR, 1.21; 95% CI, 1.11-1.31) bleeding. Absolute risk differences were small (2.0-2.1 per 1,000 person-years) and well within a range vulnerable to confounding.