Rivaroxaban Safety and Persistence in Patients With Nonvalvular Atrial Fibrillation: Prospective, Observational, Cohort, Postmarketing Study

Abstract

The aim of this study was to evaluate real-world rivaroxaban safety and persistence in patients with nonvalvular atrial fibrillation (NVAF). A prospective, observational, cohort, postmarketing study was conducted during a 6-month period. The primary outcome was bleeding, including major bleeding, nonmajor bleeding, and fecal occult blood test positivity. Secondary outcomes included nonbleeding adverse reactions, changes in laboratory parameters, and therapy persistence presented by discontinuation rate. We included 1184 patients evaluated at baseline and at 1, 3, and 6 months. During follow-up, cumulative incidences (95% confidence interval) were 0.9% (0.5%-1.7%) for major bleeding, 13.3% (11.4%-15.3%) for nonmajor bleeding, and 3.4% (2.4%-4.6%) for fecal occult blood positivity. Other adverse drug reactions were infrequent and mild, most commonly headache and fatigue, and no clinically relevant deterioration of laboratory parameters was observed. Persistence was high, with 19 (1.6%) patients excluded during the six-month follow-up. This real-world study supports the favorable safety profile and high patient persistence to rivaroxaban in NVAF. Continued monitoring of bleeding risk and enhanced patient education on persistence remain crucial for optimal outcomes.

Keywords: atrial fibrillation; bleeding risk; patient safety; rivaroxaban.