Cepeda Jose Maria, Manito Nicolas, Recio Mayoral Alejandro, Lekuona Iñaki, Castillo Orive Miguel, Blanco Labrador Elvira, Blasco María Teresa, Farré Nuria, García Pinilla José Manuel, Jiménez-Candil Javier, Rafols Carles, Gomez Doblas Juan Jose
Internal Medicine Department, Hospital Vega Baja, Orihuela, Spain.
Cardiology Department, Hospital Universitario de Bellvitge, Barcelona, Spain.
Front Cardiovasc Med. 2025 May 27;12:1451499. doi: 10.3389/fcvm.2025.1451499. eCollection 2025.
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).
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.
In FARAONIC, the median age was 73.7 years, 34.1% were women, and the median CHADS-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).
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.
本研究的目的是分析和比较利伐沙班在心房颤动（AF）合并心力衰竭（HF）患者中的有效性和安全性。
将FARAONIC研究的临床资料和结果与ROCKET-AF试验以及其他国家和国际观察性登记研究的资料和结果进行间接比较。
在FARAONIC研究中，患者的中位年龄为73.7岁，女性占34.1%，CHADS-VASc评分中位数为4.1。在ROCKET-AF研究中合并HF的利伐沙班组，这些统计数据分别为72岁、39.1%和5.1。在接受利伐沙班治疗的HF患者的国家/国际登记研究中，这些统计数据分别为74.0 - 75.3岁、40.8% - 41.4%和3.2 - 4.5。在GLORIA-AF（达比加群）和ETNA-AF（依度沙班）试验中，这些数字分别为69.9 - 75.3岁、39.3% - 41.6%和3.8 - 4.4。在HF人群中，FARAONIC研究的年度卒中或全身性栓塞发生率为0.75%（相比之下，ROCKET-AF研究为1.90%，接受利伐沙班治疗的国家/国际登记研究为0.92% - 1.2%，GLORIA-AF研究为0.82%，ETNA-AF研究为0.88%）。FARAONIC研究的大出血发生率为1.55%（相比之下，接受利伐沙班治疗的国家/国际登记研究为1.4% - 3.86%，GLORIA-AF研究为1.20%，ETNA-AF研究为1.65%）。
在临床实践中，接受利伐沙班抗凝治疗的AF合并HF患者年龄较大，合并多种疾病，血栓栓塞风险较高。尽管如此，不良事件发生率较低。
