Evidence map›Paper›PMID 40014354›Full record

ArticleClinical cardiology2025

Two-Year Follow-Up of Patients With Atrial Fibrillation Receiving Edoxaban in Routine Clinical Practice: Results From the Global ETNA-AF Program.

Raffaele De Caterina, Martin Unverdorben, Cathy Chen, Eue-Keun Choi, Yukihiro Koretsune, Doralisa Morrone, Ladislav Pecen, Peter Bramlage, Chun-Chieh Wang, Takeshi Yamashita and 1 more

4 registry-linked trialsAbstract readMulticenter Study
In one paragraph

Article in Clinical cardiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT02944019 completednot on this map

Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non Valvular Atrial Fibrillation

TypeobservationalSponsorDaiichi SankyoRan2015 to 2022Enrolled13,980ConditionsAtrial FibrillationArmsEdoxaban
NCT02951039 completednot on this map

Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non Valvular Atrial Fibrillation (NVAF)

TypeobservationalSponsorDaiichi SankyoRan2017 to 2020Enrolled3,008ConditionsAtrial FibrillationArmsEdoxaban
NCT03247569 completednot on this map

Non-interventional Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation (ETNA-AF-Thailand)

TypeobservationalSponsorDaiichi Sankyo (Thailand) Ltd., a Daiichi Sankyo CompanyRan2017 to 2022Enrolled300ConditionsAtrial FibrillationArmsEdoxaban
NCT03247582 completednot on this map

Non-interventional Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation (ETNA-AF-Hong Kong)

TypeobservationalSponsorDaiichi Sankyo Hong Kong Ltd., a Daiichi Sankyo CompanyRan2017 to 2022Enrolled234ConditionsAtrial FibrillationArmsEdoxaban
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Observational
  2. Article
  3. Article
  4. Review
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

11 authors.

Raffaele De CaterinaChair of Cardiology, University of Pisa and Cardiology Division, Pisa University Hospital, Pisa, Italy.
Martin UnverdorbenDaiichi Sankyo, Inc., Basking Ridge, USA.
Cathy ChenDaiichi Sankyo, Inc., Basking Ridge, USA.
Eue-Keun ChoiDepartment of Internal Medicine, Seoul National University College of Medicine and Seoul National University Hospital, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0002-0411-6372
Yukihiro KoretsuneNational Hospital Organization Osaka National Hospital, Osaka, Japan.
Doralisa MorroneDepartment of Surgical, Division of Cardiology, Medical and Molecular Pathology and Critical Care Medicine, University of Pisa, Pisa, Italy.
Ladislav PecenInstitute of Computer Science of the Czech Academy of Sciences, Prague, Czech Republic.
Peter BramlageInstitute for Pharmacology and Preventive Medicine, Cloppenburg, Germany.
Chun-Chieh WangDepartment of Cardiology, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan.
Takeshi YamashitaDepartment of Cardiovascular Medicine, Cardiovascular Institute, Tokyo, Japan.
Paulus KirchhofCenter for Cardiovascular Research, University of Birmingham and SWBH and UHB NHS Trusts, Birmingham, UK.

Funding

This study was sponsored by Daiichi Sankyo, Inc.
6 · The paper itself

Abstract

backgroundRandomized clinical trials demonstrated similar efficacy and improved safety of direct oral anticoagulants versus warfarin in patients with atrial fibrillation (AF). Long-term data in routine clinical practice are needed. HYPOTHESIS: Patients with AF receiving edoxaban at baseline continue to have low annualized effectiveness and safety event rates in the second year of follow-up, with regional variations observed.

methodsThe Global ETNA-AF program is a prospective, noninterventional study of patients with AF receiving edoxaban. Patient characteristics and annualized clinical event rates were assessed overall and by region across the 2-year follow-up. Annualized event rates of bleeding and thromboembolic events were assessed within the first year and conditionally in patients who were event-free up to 12 months in the second year.

resultsThis analysis comprised 26 805 patients from Europe (n = 13 164), Japan (n = 10 342), and non-Japanese Asian regions (n = 3299). Patients from Europe had the highest burden of comorbidities. The annualized event rates for major bleeding, any stroke, all-cause death, and cardiovascular death varied by region. The global annualized event rates in the first and second year were 1.31%/year and 0.86%/year for major bleeding, 1.06%/year and 0.65%/year for any stroke, 0.84%/year and 0.73%/year for cardiovascular death, and 3.05%/year and 3.18%/year for all-cause death.

conclusionAnnualized event rates for any stroke and major bleeding remained low through 2-year follow-up for patients with AF receiving edoxaban at baseline. Differences in annualized event rates for all-cause and cardiovascular mortality between Europe, Japan, and non-Japanese Asian regions may reflect variations in baseline characteristics.

trial registrationEurope, NCT02944019; Japan, UMIN000017011; Korea/Taiwan, NCT02951039; Hong Kong, NCT03247582; and Thailand, NCT03247569.

Indexed as

Atrial FibrillationFactor Xa InhibitorsPyridinesStrokeThiazolesThromboembolismAdministration, OralAgedEuropeFemaleFollow-Up StudiesHemorrhageHumansIncidenceJapanMaleedoxabanFactor Xa InhibitorsPyridinesThiazolesanticoagulationatrial fibrillationdirect oral anticoagulant (DOAC)edoxabanmajor bleedingoral anticoagulantsstroke prevention

Identifiers

PMID40014354
PMCPMC11885795

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Registered trials

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.