Effectiveness and safety of rivaroxaban in patients with atrial fibrillation and heart failure in clinical practice: an indirect comparison of national and international registries

Background The objective of the study was to analyze and compare the effectiveness and safety of rivaroxaban in patients with atrial fibrillation (AF) and heart failure (HF).Methods The clinical profile and outcomes of the FARAONIC study were indirectly compared with those of the ROCKET-AF trial and...

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Detalles Bibliográficos
Autores: Cepeda Rodrigo, José María, Manito Lorite, Nicolás, Recio Mayoral, Alejandro, Lekuona, Iñaki, Castillo Orive, Miguel, Blanco Labrador, Elvira, Blasco, Teresa, Farré López, Núria, García Pinilla, José Manuel, Jiménez Candil, F. Javier, Rafols, Carles, Gómez Doblas, Juan José
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2025
País:España
Institución:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:2445/222282
Acceso en línea:https://hdl.handle.net/2445/222282
Access Level:acceso abierto
Palabra clave:Fibril·lació auricular
Farmacologia cardiovascular
Insuficiència cardíaca
Atrial fibrillation
Cardiovascular pharmacology
Heart failure
Descripción
Sumario:Background The objective of the study was to analyze and compare the effectiveness and safety of rivaroxaban in patients with atrial fibrillation (AF) and heart failure (HF).Methods The clinical profile and outcomes of the FARAONIC study were indirectly compared with those of the ROCKET-AF trial and other national and international observational registries.Results In FARAONIC, the median age was 73.7 years, 34.1% were women, and the median CHA2DS2-VASc was 4.1. In the rivaroxaban arm of ROCKET-AF in patients with HF, these statistics were 72 years, 39.1%, and 5.1, respectively. In the national/international registries of patients with HF receiving rivaroxaban, these statistics were 74.0-75.3 years, 40.8%-41.4%, and 3.2-4.5, respectively. In the GLORIA-AF (dabigatran) and ETNA-AF (edoxaban) trials, these numbers were 69.9-75.3 years, 39.3%-41.6%, and 3.8-4.4, respectively. Among the HF populations, annualized rates of stroke or systemic embolism were 0.75% in FARAONIC (vs. 1.90% in ROCKET-AF, 0.92%-1.2% in national/international registries with rivaroxaban, 0.82% in GLORIA-AF, and 0.88% in ETNA-AF). Rates of major bleeding in FARAONIC were 1.55% (vs. 1.4%-3.86% in the national/international registries with rivaroxaban, 1.20% in GLORIA-AF, and 1.65% in ETNA-AF).Conclusion In clinical practice, AF patients with HF, anticoagulated with rivaroxaban are old, have many comorbidities and have a high thromboembolic risk. Despite this, rates of adverse events are low.