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.