ISSN 1016-5169 | E-ISSN 1308-4488
Archives of the Turkish Society of Cardiology
Evaluation of Treatment Safety in Patients with Atrial Fibrillation on Edoxaban Therapy in Real-Life in Turkey Study: Design and Rationale [Turk Kardiyol Dern Ars]
Turk Kardiyol Dern Ars. 2022; 50(2): 117-123 | DOI: 10.5543/tkda.2022.21065

Evaluation of Treatment Safety in Patients with Atrial Fibrillation on Edoxaban Therapy in Real-Life in Turkey Study: Design and Rationale

Uğur Önsel Türk1, Emin Alioğlu1, Zafer Mavioğlu2, Erdem Diker3, Ebru Özpelit4, Raffaele De Caterina5
1Department of Cardiology, İzmir Economy University School of Medicine, İzmir, Turkey
2Daichii Sankyo Turkiye, İstanbul, Turkey
3Department of Cardiology, Bayındır Hospital, Ankara, Turkey
4Department of Cardiology, Dokuz Eylül University School of Medicine, İzmir, Turkey
5Università degli Studi di Pisa, Cardiologia


OBJECTIVE
Safety and effectiveness of edoxaban was demonstrated in phase III, Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation–Thrombolysis in Myocardial Infarction 48 (ENGAGE-AF-TIMI 48) trial and is being confirmed in the post-authorization
Edoxaban Treatment in routiNe clinical prActice for patients with Atrial Fibrillation in Europe (ETNA-AF-Europe) study in patients with atrial fibrillation. However, any post-authorization safety study focusing on the safety of edoxaban treatment in Turkey with a prospective design has not been performed yet. The Evaluation of Treatment Safety in Patients with Atrial Fibrillation on Edoxaban Therapy in Real-Life in Turkey (ETAF-TR) study is designed to evaluate the safety and effectiveness of edoxaban treatment in atrial fibrillation in routine practice. The present article describes the design and rationale for the ETAF-TR Study.

METHODS
The ETAF-TR (NCT04594915) is a national, multicenter, prospective, observational study that enrolled 858 patients from 32 centers. The primary outcome of the ETAF-TR study is any overt bleeding (consisting of major bleeding or clinically relevant nonmajor bleeding or any bleeding that does not meet this definition but is considered as overt bleeding by the participating physician). Effectiveness, treatment persistence, and posology will also be evaluated in an explorative manner. The overall duration of follow-up will be 1 year; the first patient was enrolled in August 2020.

CONCLUSIONS
Results of ETAF-TR will add data from clinical practice to those from ENGAGE-AF trial and also ETNA-AF study. Comparing their results will enable to test the external validity of ENGAGE-AF trial in the country conditions.

Keywords: Arrhythmias, atrial fibrillation/flutter, edoxaban, real life, safety

How to cite this article
Uğur Önsel Türk, Emin Alioğlu, Zafer Mavioğlu, Erdem Diker, Ebru Özpelit, Raffaele De Caterina. Evaluation of Treatment Safety in Patients with Atrial Fibrillation on Edoxaban Therapy in Real-Life in Turkey Study: Design and Rationale. Turk Kardiyol Dern Ars. 2022; 50(2): 117-123

Corresponding Author: Uğur Önsel Türk
Manuscript Language: English


Journal Metrics

Journal Citation Indicator: 0.18
CiteScore: 1.1
Source Normalized Impact
per Paper:
0.22
SCImago Journal Rank: 0.348

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