Riva Letizia, Diemberger Igor, Di Pasquale Giuseppe, Attena Emilio, Sangiuolo Raffaele, De Caterina Raffaele
U.O.C. Cardiologia, Ospedale Maggiore, Bologna.
Istituto di Cardiologia, Dipartimento di Medicina Specialistica Diagnostica e Sperimentale, Università degli Studi, Bologna.
G Ital Cardiol (Rome). 2020 Feb;21(2):141-151. doi: 10.1714/3300.32708.
The introduction of direct oral anticoagulants (DOACs) has been the main therapeutic revolution in the last 20 years. Four molecules have been approved for the thromboembolic prophylaxis in patients with non-valvular atrial fibrillation (AF). After the publication of phase 3 clinical trials, many studies evaluating DOAC safety and efficacy in daily clinical practice have been published. Edoxaban is the latest DOAC available on the market, based on the results of the ENGAGE AF-TIMI 48 trial. The phase 4 ETNA-AF (Edoxaban Treatment in Routine Clinical Practice for Patients With Non-Valvular Atrial Fibrillation) observational study was designed with the aim to confirm the results of the pivotal clinical trial in routine care in unselected patients with AF. This registry involved several sites and enrolled a large population in Europe and in Italy (13 980 and 3512 patients, respectively). The broad spectrum of patients will allow to have an overview of the characteristics of the AF population and to make a comparison with previous national registries and between different European realities.
直接口服抗凝剂(DOACs)的引入是过去20年主要的治疗革命。四种药物已被批准用于非瓣膜性心房颤动(AF)患者的血栓栓塞预防。在3期临床试验发表后,许多评估DOAC在日常临床实践中安全性和有效性的研究也已发表。依度沙班是基于ENGAGE AF-TIMI 48试验结果上市的最新DOAC。4期ETNA-AF(非瓣膜性心房颤动患者依度沙班的常规临床治疗)观察性研究旨在确认在未选择的房颤患者常规护理中关键临床试验的结果。该登记研究涉及多个地点,在欧洲和意大利分别纳入了大量人群(分别为13980例和3512例患者)。广泛的患者群体将有助于全面了解房颤人群的特征,并与之前的国家登记研究以及不同的欧洲实际情况进行比较。