Cardiology Department, Hospital Universitario de Bellvitge, Barcelona, Spain.
Department of Internal Medicine, Hospital Vega Baja, Orihuela, Spain.
Clin Cardiol. 2024 Feb;47(2):e24189. doi: 10.1002/clc.24189. Epub 2023 Nov 29.
BACKGROUND: Patients with atrial fibrillation (AF) and heart failure (HF) have a high risk of thromboembolism and other outcomes and anticoagulation is recommended. HYPOTHESIS: This study was aimed to explore the risk factors associated with HF worsening in patients with AF and HF taking rivaroxaban in Spain. METHODS: Multicenter, prospective, observational study that included adults with AF and chronic HF, receiving rivaroxaban ≥4 months before entering. HF worsening was defined as first hospitalization or emergency visit because of HF exacerbation. 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, mean age was 73.7 ± 10.9 years, 64.9% were male, CHA DS -VASc was 4.1 ± 1.5, HAS-BLED was 1.6 ± 0.9% and 51.3% had HF with preserved ejection fraction. After 24 months of follow-up, 24.9% of patients developed HF worsening, 11.6% died, 2.9% had a thromboembolic event, 3.1% a major bleeding, 0.5% an intracranial bleeding and no patient had a fatal hemorrhage. Older age, the history of chronic obstructive pulmonary disease, the previous use of vitamin K antagonists, and restrictive or infiltrative cardiomyopathies, were independently associated with HF worsening. Only 6.9% of patients permanently discontinued rivaroxaban treatment. CONCLUSIONS: Approximately one out of four patients with HF and AF treated with rivaroxaban developed a HF worsening episode after 2 years of follow-up. The identification of those factors that increase the risk of HF worsening could be helpful in the comprehensive management of this population.
背景：患有心房颤动（AF）和心力衰竭（HF）的患者有发生血栓栓塞和其他不良后果的高风险，建议进行抗凝治疗。
假设：本研究旨在探索服用利伐沙班的 AF 和 HF 患者 HF 恶化的相关危险因素。
方法：这是一项多中心、前瞻性、观察性研究，纳入了在入组前至少服用利伐沙班 4 个月的 AF 和慢性 HF 成年患者。HF 恶化定义为首次因 HF 加重而住院或急诊就诊。
结果：共纳入来自西班牙 71 个中心的 672 例患者，其中 658 例（97.9%）纳入安全性分析，552 例（82.1%）纳入符合方案分析。基线时，平均年龄为 73.7±10.9 岁，64.9%为男性，CHA2DS2-VASc 评分为 4.1±1.5，HAS-BLED 评分为 1.6±0.9%，51.3%为射血分数保留的 HF。随访 24 个月后，24.9%的患者发生 HF 恶化，11.6%死亡，2.9%发生血栓栓塞事件，3.1%发生大出血，0.5%发生颅内出血，无患者发生致命性出血。年龄较大、慢性阻塞性肺疾病史、维生素 K 拮抗剂的既往使用、限制性或浸润性心肌病与 HF 恶化独立相关。仅有 6.9%的患者永久停用利伐沙班治疗。
结论：在服用利伐沙班的 HF 和 AF 患者中，大约每 4 人中就有 1 人在 2 年随访后发生 HF 恶化事件。识别增加 HF 恶化风险的因素可能有助于对该人群进行全面管理。
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