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

Jose Maria Cepeda ^1* Nicolas Manito ² Alejandro Recio Mayoral ³ Iñaki Lekuona ⁴ Miguel Castillo Orive ⁵ Elvira Blanco Labrador ⁶ María Teresa Blasco ⁷ Nuria Farré ⁸ José Manuel García Pinilla ⁹ Javier Jiménez-Candil ¹⁰ Carles Rafols ¹¹ Juan Jose Gomez Doblas ⁹

• ¹ Hospital Vega Baja, Orihuela, Spain
• ² Bellvitge University Hospital, Barcelona, Balearic Islands, Spain
• ³ Virgen Macarena University Hospital, Seville, Spain
• ⁴ Galdakao University Hospital, Galdakao, Spain
• ⁵ Ramón y Cajal University Hospital, Madrid, Madrid, Spain
• ⁶ Complexo Hospitalario Universitario de Ourense, Orense, Spain
• ⁷ Hospital Universitario Miguel Servet, Zaragoza, Aragon, Spain
• ⁸ Hospital del Mar, Parc de Salut Mar, Barcelona, Catalonia, Spain
• ⁹ Hospital Clínico Universitario Virgen de la Victoria, Málaga, Andalusia, Spain
• ¹⁰ University Hospital of Salamanca, Salamanca, Spain
• ¹¹ Bayer (Spain), Barcelona, Spain

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).The clinical profile and outcomes of the FARAONIC study were indirectly compared with those of ROCKET-AF, and other national and international observational registries.In FARAONIC, median age was 73.7 years, 34.1% were women and median CHA2DS2-VASc was 4.1. In the rivaroxaban arm of ROCKET-AF in HF patients, these numbers were 72 years, 39.1% and 5.1, respectively. In the national/international registries of patients with HF taking rivaroxaban, these figures were 74.0-75.3 years, 40.8-41.4% and 3.2-4.5, respectively. In GLORIA-AF (dabigatran) and ETNA-AF (edoxaban), these numbers were 69.9-75.3 years, 39.3-41.6%, and 3.8-4.4, respectively.Among HF population, 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 national/international registries with rivaroxaban, 1.20% in GLORIA-AF and 1.65% in ETNA-AF).In clinical practice, AF patients with HF, anticoagulated with rivaroxaban are old, have many comorbidities and a high thromboembolic risk. Despite that, rates of adverse events are low.