Olimpieri P P, Di Lenarda A, Mammarella F, Gozzo L, Cirilli A, Cuomo M, Gulizia M M, Colivicchi F, Murri G, Gabrielli D, Trotta F
Agenzia Italiana del Farmaco, Rome, Italy.
Cardiovascular Center, University Hospital and Health Services of Trieste, Italy.
Int J Cardiol Heart Vasc. 2020 Jan 23;26:100465. doi: 10.1016/j.ijcha.2019.100465. eCollection 2020 Feb.
Atrial fibrillation (AF) is the most common cardiac arrhythmia associated with an increased risk of stroke and thromboembolism. Anticoagulation with Vitamin K antagonists (VKAs) or with novel oral anti-coagulants (NOACs) represents the cornerstone of the pharmacological treatment to reduce the risk of thromboembolism. This study aims to provide real-world data from a whole large European country about NOAC use in "non-valvular atrial fibrillation" (NVAF).
We analysed the Italian Medicines Agency (AIFA) monitoring registries collecting data of a nationwide cohort of patients with "NVAF" treated with NOACs. Using logistic regression analysis, baseline characteristics and treatment discontinuation information were compared among initiators of the 4 NOACs.
In the reference period, the NOAC database collected data for 683,172 patients. The median age was 78 years with 19.5% aged 85 or older. Overall, the treatments were in accordance with guidelines. About 1/3 of patients switched from a prior VKA treatment; in the 72.3% of cases, these patients had a labile International Normalized Ratio (INR) at first prescription. The most prescribed NOAC was rivaroxaban, followed by apixaban, dabigatran and edoxaban.
This study is the largest European real-world study ever published on NOACs. It includes all Italian patients treated with NOACs since 2013 accounting for about 1/3 of subjects with AF. The enrolled population consisted of very elderly patients, at high risk of ischemic adverse events. The AIFA registries are consolidated tools that guarantee the appropriateness of prescription and provide important information for the governance of National Health System by collecting real-world data.
心房颤动（AF）是最常见的心律失常，与中风和血栓栓塞风险增加相关。使用维生素K拮抗剂（VKA）或新型口服抗凝剂（NOAC）进行抗凝是降低血栓栓塞风险的药物治疗基石。本研究旨在提供来自整个欧洲大国关于“非瓣膜性心房颤动”（NVAF）中使用NOAC的真实世界数据。
我们分析了意大利药品管理局（AIFA）的监测登记处，这些登记处收集了全国范围内接受NOAC治疗的“NVAF”患者队列的数据。使用逻辑回归分析，比较了4种NOAC起始使用者的基线特征和治疗中断信息。
在参考期内，NOAC数据库收集了683172例患者的数据。中位年龄为78岁，19.5%的患者年龄在85岁及以上。总体而言，治疗符合指南。约1/3的患者从先前的VKA治疗转换而来；在72.3%的病例中，这些患者在首次处方时国际标准化比值（INR）不稳定。最常处方的NOAC是利伐沙班，其次是阿哌沙班、达比加群和依度沙班。
本研究是欧洲有史以来发表的关于NOAC的最大规模真实世界研究。它纳入了自2013年以来所有接受NOAC治疗的意大利患者，约占AF患者的1/3。入组人群包括非常老年的患者，有发生缺血性不良事件的高风险。AIFA登记处是经过整合的工具，通过收集真实世界数据保证处方的合理性，并为国家卫生系统的管理提供重要信息。
