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

Abstract

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.