Outcomes and factors associated with mortality in patients with atrial fibrillation and heart failure: FARAONIC study

Abstract

Background: Heart failure (HF) and atrial fibrillation (AF) are common and coexistent conditions.

Hypothesis: To investigate the adverse events and mortality risk factors in patients with AF and HF treated with rivaroxaban in Spain.

Methods: Multicenter, prospective and observational study with a follow-up of 2 years, that included adults, with a diagnosis of nonvalvular AF and chronic HF, anticoagulated with rivaroxaban at least 4 months before being enrolled.

Results: A total of 672 patients from 71 Spanish centers were recruited, of whom 658 (97.9%) were included in the safety analysis and 552 (82.1%) in the per protocol analysis. At baseline, the mean age was 73.7 ± 10.9 years, 65.9% were male, 51.3% had HF with preserved ejection fraction and 58.7% were on New York Heart Association functional class II. CHA₂ DS₂ -VASc was 4.1 ± 1.5. During the follow-up, 11.6% of patients died and around one-quarter of patients were hospitalized or visited the emergency department, being HF worsening/progression the main cause (51.1%), with a 2.9% of thromboembolic events and 2.0% of acute coronary syndromes. Major bleeding occurred in 3.1% of patients, with 0.5% experiencing intracranial bleeding but no fatalities. Compliance with HF treatment was associated with a lower risk of death (hazard ratio: 0.092; 95% confidence interval: 0.03-0.31).

Conclusions: Among patients with HF and AF anticoagulated with rivaroxaban, incidences of thromboembolic or hemorrhagic complications were low. The most important factor for improving survival was compliance with HF drugs, what strengths the need for early treatment with HF disease-modifying therapy and anticoagulation.

Keywords: anticoagulation; atrial fibrillation; death; direct oral anticoagulant; heart failure; hemorrhage; rivaroxaban; thromboembolism; worsening heart failure.

Figure 1

Flow chart of the study.