Open AccessThe global Edoxaban Treatment in routine cliNical prActice (ETNA) noninterventional study program: rationale and design
Author(s) -
De Caterina Raffaele,
Agnelli Giancarlo,
Laeis Petra,
Unverdorben Martin,
Rauer Heiko,
Wang ChunChieh,
Nakamura Mashio,
Chiu KuanMing,
Reimitz PaulEgbert,
Koretsune Yukihiro,
Chen Cathy,
Thee Ulrike,
Kaburagi Jumpei,
Kim YoungHoon,
Choi WonIl,
Yamashita Takeshi,
Cohen Alexander,
Kirchhof Paulus
Publication year - 2019
Publication title -
clinical cardiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.263
H-Index - 72
eISSN - 1932-8737
pISSN - 0160-9289
DOI - 10.1002/clc.23279
Subject(s) - medicine , edoxaban , intensive care medicine , clinical trial , deep vein , atrial fibrillation , clinical practice , pulmonary embolism , emergency medicine , thrombosis , family medicine , dabigatran , warfarin
Background Randomized controlled trials showed the nonvitamin K oral anticoagulant (NOAC) edoxaban was effective and safe for stroke and systemic embolism prevention in nonvalvular atrial fibrillation (AF) and for the prevention and treatment of venous thromboembolism (VTE; including pulmonary embolism and deep vein thrombosis). Additional research is needed to evaluate the effects of edoxaban in routine clinical practice. Therefore, the Edoxaban Treatment in routine cliNical prActice (ETNA) program is being conducted to provide routine clinical care data on characteristics and outcomes in patients with AF or VTE receiving edoxaban. Methods The Global ETNA program integrates prospectively collected data from edoxaban patients in regional ETNA noninterventional studies across Europe, Japan, and East and Southeast Asia into indication‐specific databases for AF and VTE. Targeted enrollment is >31 000 patients (AF >26 000; VTE >4500), with a follow‐up of 2 years for AF and 1 year for VTE. Data integration will be possible using consistent terminology, parameter definitions, and data collection across the regional noninterventional studies. Safety and effectiveness data will be assessed. Crude rates of outcomes including bleeding and thromboembolic events will be reported. Results Globally, enrollment began in early 2015 and is ongoing. Conclusions Global ETNA will generate the largest integrated prospective repository of routine clinical care data for a single NOAC in patients with AF or VTE. It will provide important information on the safety of edoxaban in routine clinical care and gather further information on its effectiveness.