Evidence map›Paper›PMID 31650560›Full record

ArticleClinical cardiology2019

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 and 8 more

Abstract read
In one paragraph

Article in Clinical cardiology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Raffaele De CaterinaChair of Cardiology, University of Pisa, Pisa, Italy.
Giancarlo AgnelliInternal and Cardiovascular Medicine-Stroke Unit, University of Perugia, Perugia, Italy.
Petra LaeisClinical Operations and Biostatistics and Data Operations, Daiichi Sankyo Europe GmbH, Munich, Germany.
Martin UnverdorbenGlobal Medical Affairs, Daiichi Sankyo, Inc., Basking Ridge, New Jersey.
Heiko RauerClinical Operations and Biostatistics and Data Operations, Daiichi Sankyo Europe GmbH, Munich, Germany.
Chun-Chieh WangCardiology, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan, Republic of China.
Mashio NakamuraDepartment of Internal Medicine, Pediatrics and Cardiology, Nakamura Medical Clinic, Kuwana, Mie, Japan.
Kuan-Ming ChiuCardiovascular Center, Far Eastern Memorial Hospital, New Taipei City, Taiwan, Republic of China.
Paul-Egbert ReimitzClinical Operations and Biostatistics and Data Operations, Daiichi Sankyo Europe GmbH, Munich, Germany.
Yukihiro KoretsuneNational Hospital Organization, Osaka National Hospital, Osaka, Japan.
Cathy ChenGlobal Medical Affairs, Daiichi Sankyo, Inc., Basking Ridge, New Jersey.
Ulrike TheeClinical Operations and Biostatistics and Data Operations, Daiichi Sankyo Europe GmbH, Munich, Germany.
Jumpei KaburagiMedical Science Department, Daiichi Sankyo, Tokyo, Japan.
Young-Hoon KimDepartment of Internal Medicine, Korea University College of Medicine and Korea University Medical Center, Seoul, Republic of Korea.
Won-Il ChoiDepartment of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Republic of Korea.
Takeshi YamashitaDepartment of Cardiovascular Medicine, Cardiovascular Institute, Tokyo, Japan.
Alexander CohenGuy's and St Thomas' NHS Foundation Trust, King's College London, London, UK.
Paulus KirchhofInstitute of Cardiovascular Sciences, University of Birmingham and SWBH and UHB NHS Trusts of Birmingham, School of Clinical and Experimental Medicine, Birmingham, UK.

Funding

Daiichi Sankyo, Inc.
6 · The paper itself

Abstract

backgroundRandomized 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.

methodsThe 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.

resultsGlobally, enrollment began in early 2015 and is ongoing.

conclusionsGlobal 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.

Indexed as

Atrial FibrillationDatabases, FactualFactor Xa InhibitorsHumansPyridinesThiazolesVenous ThromboembolismedoxabanFactor Xa InhibitorsPyridinesThiazoles

Identifiers

PMID31650560
PMCPMC6906985

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.