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 Manito²Alejandro Recio Mayoral³Iñaki Lekuona⁴Miguel Castillo Orive⁵Elvira Blanco Labrador⁶María Teresa Blasco⁷Nuria Farré⁸José Manuel García Pinilla⁹Javier Jiménez-Candil¹⁰Carles Rafols¹¹Juan Jose Gomez Doblas⁹

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