Evidence map›Paper›PMID 39601397›Full record

ArticleKorean circulation journal2025

A Real-World, Prospective, Observational Study of Rivaroxaban on Prevention of Stroke and Non-Central Nervous Systemic Embolism in Renally Impaired Korean Patients With Non-Valvular Atrial Fibrillation: XARENAL.

Il-Young Oh, Chang Hoon Lee, Eue-Keun Choi, Hong Euy Lim, Yong-Seog Oh, Jong-Il Choi, Min-Soo Ahn, Ju Youn Kim, Nam-Ho Kim, Namsik Yoon and 2 more

Registry-linked trialAbstract read
In one paragraph

Article in Korean circulation journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03746301 (Xarelto® on Prevention of Stroke and Non-Central Nervous Systemic), 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.

NCT03746301 completednot on this map

Xarelto® on Prevention of Stroke and Non-Central Nervous Systemic (CNS) Embolism in Renally Impaired Korean Patients With Non-valvular Atrial Fibrillation (NVAF)

TypeobservationalSponsorBayerRan2018 to 2021Enrolled924ConditionsNon-valvular Atrial Fibrillation (NVAF)ArmsRivaroxaban(Xarelto,BAY 59-7939)
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. 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

12 authors.

Il-Young OhDivision of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.ORCID https://orcid.org/0000-0002-5584-605X
Chang Hoon LeeDivision of Cardiology, Department of Internal Medicine, Veterans Health Service Medical Center, Seoul, Korea.ORCID https://orcid.org/0000-0002-1622-272X
Eue-Keun ChoiDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Korea.ORCID https://orcid.org/0000-0002-0411-6372
Hong Euy LimDivision of Cardiology, Department of Internal Medicine, Hallym University Medical Center, 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
Jong-Il ChoiDivision of Cardiology, Department of Internal Medicine, Korea University Medical Center, Seoul, Korea.ORCID https://orcid.org/0000-0001-6617-508X
Min-Soo AhnDivision of Cardiology, Yonsei University Wonju College of Medicine, Wonju, Korea.ORCID https://orcid.org/0000-0001-5730-8215
Ju Youn KimDivision of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.ORCID https://orcid.org/0009-0003-2452-4423
Nam-Ho KimDepartment of Internal Medicine, Wonkwang University Hospital, Wonkwang University School of Medicine, Iksan, Korea.ORCID https://orcid.org/0000-0003-4559-5493
Namsik YoonDivision of Cardiology, Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea.ORCID https://orcid.org/0000-0001-9112-150X
Martin SandmannClinStat GmbH, Hurth, Germany.
Kee-Joon ChoiDepartment of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. kjchoi@amc.seoul.kr.ORCID https://orcid.org/0000-0002-9055-049X

Funding

Bayer Korea
6 · The paper itself

Abstract

BACKGROUND AND

objectivesSeveral real-world studies have been done in patients with nonvalvular atrial fibrillation (NVAF); however, information on its safety profile in patients with renal impairment is limited. XARENAL, a real-world study, aimed to prospectively investigate the safety profile of rivaroxaban in patients with NVAF with renal impairment (creatinine clearance [CrCl], 15-49 mL/min).

methodsXARENAL is an observational single-arm cohort study in renal impairment NVAF patients. Patients were followed up approximately every 3 months for 1 year or until 30 days following early discontinuation. The primary endpoint was major bleeding events. All adverse events, symptomatic thromboembolic events, treatment duration, and renal function change from baseline were the secondary endpoints.

resultsXARENAL included 888 patients from 29 study sites. Overall, 713 (80.3%) had moderate renal impairment (CrCl, 30-49 mL/min), and 175 (19.7%) had severe renal impairment (CrCl, 15-29 mL/min) with a mean estimated glomerular filtration rate (eGFR) of 45.2±13.0 mL/min/1.73 m². The mean risk scores were 3.3±1.4 and 1.7±0.9 for CHA₂DS₂-VASc score and HAS-BLED score, respectively. An incidence proportion of 5.6% (6.2 events per 100 patient-years) developed major bleeding; however, fatal bleeding occurred in 0.5% (0.5 events per 100 patient-years). The mean change in the eGFR was 2.22±26.47 mL/min/1.73 m² per year.

conclusionsXARENAL observed no meaningful differences in major bleeding events from other previous findings as well as renal function changes in rivaroxaban-treated NVAF patients with renal impairment, which is considered to be acceptable in clinical practice.

trial registrationClinicalTrials.gov Identifier: NCT03746301.

Indexed as

Atrial fibrillationBleedingRenal insufficiencyRivaroxabanSafety

Identifiers

PMID39601397
PMCPMC11875974

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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.