Evidence map›Paper›PMID 38859644›Full record

ArticleKorean circulation journal2024

Optimal Dose of Edoxaban for Very Elderly Atrial Fibrillation Patients at High Risk of Bleeding: The LEDIOS Registry.

Ju Youn Kim, Juwon Kim, Seung-Jung Park, Kyoung-Min Park, Sang-Jin Han, Dae Kyeong Kim, Yae Min Park, Sung Ho Lee, Jong Sung Park, Young Keun On and 1 more

Registry-linked trialAbstract read
In one paragraph

Article in Korean circulation journal, 2024. 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 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Direct oral anticoagulants in very elderly and high-bleeding-risk patients with atrial fibrillation often excluded from oral anticoagulation therapy: a nationwide population-based cohort study.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025
    Article
  3. 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

11 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
Juwon 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/0000-0002-7210-6109
Seung-Jung ParkDivision 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/0000-0003-3288-0594
Kyoung-Min ParkDivision 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/0000-0002-5416-9691
Sang-Jin HanDivision of Cardiology, Hallym University Sacred Heart Hospital, Anyang, Korea.ORCID https://orcid.org/0000-0003-4451-468X
Dae Kyeong KimDepartment of Cardiology, Busan Paik Hospital, Inje University College of Medicine , Busan, Korea.ORCID https://orcid.org/0000-0003-0553-7010
Yae Min ParkDivision of Cardiology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea.ORCID https://orcid.org/0000-0003-3597-9768
Sung Ho LeeDivision of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-1018-7871
Jong Sung ParkDepartment of Cardiology, Dong-A University Hospital, Busan, Korea.ORCID https://orcid.org/0000-0001-6996-2476
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
LEDIOS Registry Investigators

Funding

Daiichi Sankyo Korea
6 · The paper itself

Abstract

BACKGROUND AND

objectivesOptimal anticoagulation in very elderly patients is challenging due to the high risk of anticoagulant-induced bleeding. The aim of this study was to assess outcomes of on-label reduced-dose edoxaban (30 mg) in very elderly patients who had additional risk factors for bleeding.

methodsThis was a multi-center, prospective, non-interventional observational study to evaluate the efficacy and safety of on-label reduced-dose edoxaban in atrial fibrillation (AF) patients 80 years of age or older and who had more than 1 risk factor for bleeding.

resultsA total of 2448 patients (mean age 75.0±8.3 years, 801 [32.7%] males) was included in the present study, and 586 (23.9%) were 80 years of age or older with additional risk factors for bleeding. Major bleeding events occurred frequently among very elderly AF patients who had additional bleeding risk factors compared to other patients (unadjusted hazard ratio [HR], 2.16; 95% confidence interval [CI], 1.16-4.02); however, there were no significant differences in stroke incidence (HR, 1.86; 95% CI, 0.98-3.55). There were no significant differences for either factor after adjusting for age and sex (adjusted HR, 1.65; 95% CI, 0.75-3.62 for major bleeding; adjusted HR, 1.13; 95% CI, 0.51-2.50 for stroke).

conclusionsIn very elderly AF patients with comorbidities associated with greater risk of bleeding, the incidence of major bleeding events was significantly increased. In addition, risk of stroke showed tendency to increase in same population. Effective anticoagulation therapy might be important in these high-risk population, and close observation of bleeding events might also be required.

trial registrationClinicalTrials.gov Identifier: NCT03554837.

Indexed as

Atrial fibrillationBleedingEdoxabanElderlyRisk factorsStroke

Identifiers

PMID38859644
PMCPMC11252638

What OpenQuestion holds

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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.