Rivaroxaban use in patients with atrial fibrillation demonstrated low rates of major bleeding (1.7 events/100 patient-years; 95% CI 1.5-2.0) and all-cause death (1.9 events/100 patient-years).
Observational (n=11,121)
Yes
What is the real-world safety and effectiveness profile of rivaroxaban in patients with atrial fibrillation?
In a large, global, prospective real-world registry, rivaroxaban demonstrated low rates of major bleeding and stroke in patients with atrial fibrillation, with consistent results across regions.
BACKGROUND: The efficacy of direct oral anticoagulants (DOACs) for stroke prevention in patients with atrial fibrillation (AF) has been established in clinical trials. However, well-conducted, prospective, real-world observational studies of the safety and effectiveness of DOACs are needed. OBJECTIVES: This study sought to assess the real-world safety profile of rivaroxaban through a pooled analysis of patients with AF enrolled in the XANTUS (Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation) program worldwide. METHODS: A pre-planned pooled analysis of the XANTUS, XANAP (Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Asia), and XANTUS-EL (Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Latin America and EMEA Region) registries was performed. Patients with AF newly starting rivaroxaban for stroke prevention were followed for 1 year. Primary outcomes were treatment-emergent major bleeding, adverse events (AEs)/serious AEs, and all-cause death. Secondary outcomes included treatment-emergent thromboembolic events and nonmajor bleeding. Major outcomes were centrally adjudicated. RESULTS: Overall, 11,121 patients were included (mean age 70.5 ± 10.5 years; female 42.9%). Comorbidities included heart failure (21.2%), hypertension (76.2%), and diabetes (22.3%). Event rates were: events/100 patient-years: major bleeding 1.7 (95% confidence interval CI: 1.5 to 2.0; lowest: Latin America 0.7; highest: Western Europe, Canada, and Israel 2.3); all-cause death 1.9 (95% CI: 1.6 to 2.2; lowest: Eastern Europe 1.5; highest: Latin America, Middle East, and Africa 2.7); and stroke or systemic embolism 1.0 (95% CI: 0.8 to 1.2; lowest: Latin America 0; highest: East Asia 1.8). One-year treatment persistence was 77.4% (lowest: East Asia 66.4%; highest: Eastern Europe 84.4%). CONCLUSIONS: This large, prospective, real-world analysis in 11,121 patients from 47 countries showed low bleeding and stroke rates in rivaroxaban-treated patients with AF, with low treatment discontinuation in different regions of the world. Results were broadly consistent across regions. (Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation XANTUS; NCT01606995; Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Latin America and EMEA Region XANTUS-EL; NCT01800006; and Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Asia XANAP; NCT01750788).
Kirchhof et al. (Sun,) conducted a observational in Atrial fibrillation (n=11,121). Rivaroxaban was evaluated on Treatment-emergent major bleeding, adverse events (AEs)/serious AEs, and all-cause death (95% CI 1.5-2.0). Rivaroxaban use in patients with atrial fibrillation demonstrated low rates of major bleeding (1.7 events/100 patient-years; 95% CI 1.5-2.0) and all-cause death (1.9 events/100 patient-years).