Impact of heart failure on the clinical profile and outcomes in patients with atrial fibrillation treated with rivaroxaban. Data from the EMIR study

Manuel Anguita Sánchez; Francisco Marı́n; Jaime Masjuán; Juan Cosı́n-Sales; José Manuel Vázquez‐Rodríguez; Vivencio Barrios; Gonzalo Barón‐Esquivias; Iñaki Lekuona; Alejandro Pérez Cabeza; Román Freixa‐Pamias; Francisco Javier Parra Jimenez; Mohamed Monzer Khanji Khatib; Marcelo Sanmartı́n

doi:10.5603/cj.a2022.0091

October 6, 2022Cardiology JournalOpen Access

Impact of heart failure on the clinical profile and outcomes in patients with atrial fibrillation treated with rivaroxaban. Data from the EMIR study

View Full Paper

Ask AI

Bookmark

Share

Why the study?

The study was conducted to analyze the impact of baseline heart failure on the clinical profile and outcomes of patients with atrial fibrillation anticoagulated with rivaroxaban.

Does the presence of heart failure increase the risk of adverse outcomes in patients with atrial fibrillation treated with rivaroxaban?

Structured PICO

Does the presence of heart failure increase the risk of adverse outcomes in patients with atrial fibrillation treated with rivaroxaban?

P

Population

1,433 adults with atrial fibrillation (AF) anticoagulated with rivaroxaban ≥ 6 months before inclusion, recruited from 79 Spanish centers.

I

Intervention

Presence of heart failure (HF) at baseline (n=326)

C

Comparator

Absence of heart failure at baseline

O

Outcome

Major adverse cardiovascular events (MACE) (non-fatal myocardial infarction, revascularization and cardiovascular death), stroke/systemic embolism/transient ischemic attack, cardiovascular death, and major bleedingcomposite

In AF patients treated with rivaroxaban, concomitant heart failure is independently associated with a higher risk of MACE and cardiovascular mortality, but not with increased thromboembolic or major bleeding events.

Implication

HF in rivaroxaban-treated AF signals higher-risk profile; leaves open whether it independently modifies outcomes.

Abstract

BACKGROUND: The aim of this study was to analyze the impact of the presence of heart failure (HF) on the clinical profile and outcomes in patients with atrial fibrillation (AF) anticoagulated with rivaroxaban. METHODS: Observational and non-interventional study that included AF adults recruited from 79 Spanish centers, anticoagulated with rivaroxaban ≥ 6 months before inclusion. Data were analyzed according to baseline HF status. RESULTS: Out of 1,433 patients, 326 (22.7%) had HF at baseline. Compared to patients without HF, HF patients were older (75.3 ± 9.9 vs. 73.8 ± 9.6 years; p = 0.01), had more diabetes (36.5% vs. 24.3%; p < 0.01), coronary artery disease (28.2% vs. 12.9%; p < 0.01), renal insufficiency (31.7% vs. 22.6%; p = 0.01), higher CHA2DS2-VASc (4.5 ± 1.6 vs. 3.2 ± 1.4; p < 0.01) and HAS-BLED (1.8 ± 1.1 vs. 1.5 ± 1.0; p < 0.01). After a median follow-up of 2.5 years, among HF patients, annual rates of stroke/systemic embolism/transient ischemic attack, major adverse cardiovascular events (MACE) (non-fatal myocardial infarction, revascularization and cardiovascular death), cardiovascular death, and major bleeding were 1.2%, 3.0%, 2.0%, and 1.4%, respectively. Compared to those patients without HF, HF patients had greater annual rates of MACE (3.0% vs. 0.5%; p < 0.01) and cardiovascular death (2.0% vs. 0.2%; p < 0.01), without significant differences regarding other outcomes, including thromboembolic or bleeding events. Previous HF was an independent predictor of MACE (odds ratio 3.4; 95% confidence interval 1.6-7.3; p = 0.002) but not for thromboembolic events or major bleeding. CONCLUSIONS: Among AF patients anticoagulated with rivaroxaban, HF patients had a worse clinical profile and a higher MACE risk and cardiovascular mortality. HF was independently associated with the development of MACE, but not with thromboembolic events or major bleeding.