Evidence map›Paper›PMID 36513051›Full record

Trial reportJournal of Korean medical science2022

Outcomes of On-Label Reduced-Dose Edoxaban in Patients With Atrial Fibrillation: The LEDIOS Registry.

Ju Youn Kim, Eue Keun Choi, Hong Euy Lim, Yong-Seog Oh, Youngjin Cho, Young Keun On

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in Journal of Korean medical science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03554837 (A Multicenter, Prospective, Non-interventional, Cohort Study to Evaluate the Safety and Effectiveness of Low Dose Edoxaban in Patients With Non-valvular Atrial Fibrillation), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

NCT03554837 unknown statusnot on this map

A Multicenter, Prospective, Non-interventional, Cohort Study to Evaluate the Safety and Effectiveness of Low Dose Edoxaban in Patients With Non-valvular Atrial Fibrillation (NVAF), Who Are Applicable to Any of the Dose Reduction Criteria

TypeobservationalSponsorSamsung Medical CenterRan2018 to 2021Enrolled2,562ConditionsAtrial Fibrillation
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. The role and mechanism of heme oxygenase-1 in arrhythmias.Journal of molecular medicine (Berlin, Germany) · 2024
    Review
  5. Article
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

6 authors.

Ju Youn KimDivision of Cardiology, Department of Internal Medicine, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-5323-3428
Eue Keun ChoiDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-0411-6372
Hong Euy LimDivision of Cardiology, Hallym University Sacred Heart Hospital, Anyang, Korea.ORCID https://orcid.org/0000-0001-8102-8352
Yong-Seog OhDivision of Cardiology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.ORCID https://orcid.org/0000-0003-3567-6505
Youngjin ChoDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.ORCID https://orcid.org/0000-0002-1435-6070
Young Keun OnDivision of Cardiology, Department of Internal Medicine, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. yk.on@samsung.com.ORCID https://orcid.org/0000-0003-1025-7283

Funding

Daiichi Sankyo Korea PHO0203841
6 · The paper itself

Abstract

backgroundNon-vitamin K antagonist oral anticoagulants (NOACs) are effective in preventing thromboembolisms and reduce the risk of bleeding compared with warfarin. There are few reports on the outcomes of on-label reduced-dose NOACs. The aim of this study was to assess the safety and efficacy of on-label reduced-dose edoxaban in patients with atrial fibrillation (AF).

methodsThis study is a multi-center, prospective, non-interventional study to evaluate the safety and efficacy of on-label reduced-dose edoxaban in patients with AF. We evaluated outcomes of major bleeding, stroke or systemic embolism, all-cause death, and composite clinical outcomes.

resultsA total of 2,448 patients (mean age 75.0 ± 8.3 years, 801 [32.7%] males) was included in the present study. The mean CHA

conclusionsThis study was the largest prospective real-world study to investigate the safety and efficacy of on-label low-dose edoxaban in an Asian population. Reduced-dose edoxaban can be used safely in patients with severe renal dysfunction or extremely low body weight. Our observation suggests that physicians should consider bleeding risk even in a low-dose regimen.

trial registrationClinicalTrials.gov Identifier: NCT03554837.

Indexed as

Atrial FibrillationEmbolismKidney DiseasesStrokeAdministration, OralAgedAged, 80 and overAnticoagulantsBody WeightFactor Xa InhibitorsFemaleHemorrhageHumansMaleProspective StudiesPyridinesAnticoagulantsedoxabanFactor Xa InhibitorsPyridinesThiazolesAtrial FibrillationEfficacyOral AnticoagulantsReduced DoseSafety

Identifiers

PMID36513051
PMCPMC9745682

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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.