The global Edoxaban Treatment in routine cliNical prActice (ETNA) noninterventional study program: rationale and design

Raffaele De Caterina, Giancarlo Agnelli, Petra Laeis, Martin Unverdorben, Heiko Rauer, Chun Chieh Wang, Mashio Nakamura, Kuan Ming Chiu, Paul Egbert Reimitz, Yukihiro Koretsune, Cathy Chen, Ulrike Thee, Jumpei Kaburagi, Young Hoon Kim, Won Il Choi, Takeshi Yamashita, Alexander Cohen, Paulus Kirchhof

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)1147-1154
Number of pages8
JournalClinical Cardiology
Volume42
Issue number12
DOIs
Publication statusPublished - 2019 Dec 1

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Atrial Fibrillation
Anticoagulants
Therapeutics
Safety
Southeastern Asia
Far East
Venous Thromboembolism
Embolism
Pulmonary Embolism
Terminology
Venous Thrombosis
edoxaban
Japan
Randomized Controlled Trials
Stroke
Databases
Hemorrhage
Research

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

De Caterina, R., Agnelli, G., Laeis, P., Unverdorben, M., Rauer, H., Wang, C. C., ... Kirchhof, P. (2019). The global Edoxaban Treatment in routine cliNical prActice (ETNA) noninterventional study program: rationale and design. Clinical Cardiology, 42(12), 1147-1154. https://doi.org/10.1002/clc.23279

The global Edoxaban Treatment in routine cliNical prActice (ETNA) noninterventional study program : rationale and design. / De Caterina, Raffaele; Agnelli, Giancarlo; Laeis, Petra; Unverdorben, Martin; Rauer, Heiko; Wang, Chun Chieh; Nakamura, Mashio; Chiu, Kuan Ming; Reimitz, Paul Egbert; Koretsune, Yukihiro; Chen, Cathy; Thee, Ulrike; Kaburagi, Jumpei; Kim, Young Hoon; Choi, Won Il; Yamashita, Takeshi; Cohen, Alexander; Kirchhof, Paulus.

In: Clinical Cardiology, Vol. 42, No. 12, 01.12.2019, p. 1147-1154.

Research output: Contribution to journalArticle

De Caterina, R, Agnelli, G, Laeis, P, Unverdorben, M, Rauer, H, Wang, CC, Nakamura, M, Chiu, KM, Reimitz, PE, Koretsune, Y, Chen, C, Thee, U, Kaburagi, J, Kim, YH, Choi, WI, Yamashita, T, Cohen, A & Kirchhof, P 2019, 'The global Edoxaban Treatment in routine cliNical prActice (ETNA) noninterventional study program: rationale and design', Clinical Cardiology, vol. 42, no. 12, pp. 1147-1154. https://doi.org/10.1002/clc.23279
De Caterina, Raffaele ; Agnelli, Giancarlo ; Laeis, Petra ; Unverdorben, Martin ; Rauer, Heiko ; Wang, Chun Chieh ; Nakamura, Mashio ; Chiu, Kuan Ming ; Reimitz, Paul Egbert ; Koretsune, Yukihiro ; Chen, Cathy ; Thee, Ulrike ; Kaburagi, Jumpei ; Kim, Young Hoon ; Choi, Won Il ; Yamashita, Takeshi ; Cohen, Alexander ; Kirchhof, Paulus. / The global Edoxaban Treatment in routine cliNical prActice (ETNA) noninterventional study program : rationale and design. In: Clinical Cardiology. 2019 ; Vol. 42, No. 12. pp. 1147-1154.
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T1 - The global Edoxaban Treatment in routine cliNical prActice (ETNA) noninterventional study program

T2 - rationale and design

AU - De Caterina, Raffaele

AU - Agnelli, Giancarlo

AU - Laeis, Petra

AU - Unverdorben, Martin

AU - Rauer, Heiko

AU - Wang, Chun Chieh

AU - Nakamura, Mashio

AU - Chiu, Kuan Ming

AU - Reimitz, Paul Egbert

AU - Koretsune, Yukihiro

AU - Chen, Cathy

AU - Thee, Ulrike

AU - Kaburagi, Jumpei

AU - Kim, Young Hoon

AU - Choi, Won Il

AU - Yamashita, Takeshi

AU - Cohen, Alexander

AU - Kirchhof, Paulus

PY - 2019/12/1

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N2 - 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.

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