As part of the ROCKET AF trial, researchers from multiple institutions, including Harvard Medical School; Mount Sinai Medical Center; Janssen Research & Development; and Bayer HealthCare Pharmaceuticals, randomized 14,264 patients with nonvalvular AF to receive either rivaroxaban or dose-adjusted warfarin. Post-hoc analysis was performed on all patients while receiving study medication until 2 days after the last dose.
Results showed that GI bleeding events (upper, lower, rectal) occurred more frequently in patients receiving rivaroxaban (n=394) than warfarin (n=290). In addition, major and nonmajor, clinically relevant bleeding occurred more frequently with rivaroxaban use than warfarin use. However, there were fewer fatal GI bleeds with rivaroxaban and the absolute fatality rate was very low.