Evidence map›Paper›PMID 38442717›Full record

Observational studyJournal of Korean medical science2024

Comparison of High- and Low-Dose Rivaroxaban Regimens in Elderly East Asian Patients With Atrial Fibrillation.

Ju Youn Kim, Juwon Kim, Seung-Jung Park, Kyoung-Min Park, June Soo Kim, Sung-Hwan Kim, Jaemin Shim, Eue Keun Choi, Dae-Hyeok Kim, Il-Young Oh and 2 more

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyObservational Study
In one paragraph

Observational study in Journal of Korean medical science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04096547 (A Prospective, Non-interventional, Multicenter Observational Study to Evaluate the Effectiveness and Safety of Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 40% of its field
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.

NCT04096547 unknown statusnot on this map

A Prospective, Non-interventional, Multicenter Observational Study to Evaluate the Effectiveness and Safety of Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment

TypeobservationalSponsorSamsung Medical CenterRan2019 to 2022Enrolled1,200ConditionsAtrial Fibrillation, Rivaroxaban, Elderly, Renal InsufficiencyArmsRivaroxaban
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 citations in OpenAlex.

  1. Article
  2. 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 at 6 institutions in 1 country.

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/0000-0002-8406-3142
June Soo 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/0000-0003-3367-6229
Sung-Hwan KimDivision 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/0000-0001-6805-0416
Jaemin ShimDivision of Cardiology, Department of Internal Medicine, Korea University College of Medicine and Korea University Anam Hospital, Seoul, Korea.ORCID https://orcid.org/0000-0001-8251-1522
Eue Keun ChoiDepartment of Internal Medicine, Seoul National University College of Medicine and Seoul National University Hospital, Seoul, Korea.ORCID https://orcid.org/0000-0002-0411-6372
Dae-Hyeok KimInha University College of Medicine and Inha University Hospital, Incheon, Korea.ORCID https://orcid.org/0000-0001-8308-7866
Il-Young OhCardiovascular Center, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.ORCID https://orcid.org/0000-0002-5584-605X
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
XAIENT Study Group
Samsung Medical Center · KRInha University Hospital · KRKorea University · KRSeoul National University Bundang Hospital · KRSeoul National University Hospital · KRThe Catholic University of Korea Seoul St. Mary's Hospital · KR

Funding

Bayer
6 · The paper itself

Abstract

backgroundIn the Rivaroxaban Once-daily oral direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) trial, rivaroxaban 20 mg was the on-label dose, and the dose-reduction criterion for rivaroxaban was a creatinine clearance of < 50 mL/min. Some Asian countries are using reduced doses label according to the J-ROCKET AF trial. The aim of this study was to assess the safety and efficacy of a high-dose rivaroxaban regimen (HDRR, 20/15 mg) and low-dose rivaroxaban regimen (LDRR, 15/10 mg) among elderly East Asian patients with atrial fibrillation (AF) in real-world practice.

methodsThis study was a multicenter, prospective, non-interventional observational study designed to evaluate the efficacy and safety of rivaroxaban in AF patients > 65 years of age with or without renal impairment.

resultsA total of 1,093 patients (mean age, 72.8 ± 5.8 years; 686 [62.9%] men) were included in the analysis, with 493 patients allocated to the HDRR group and 598 patients allocated to the LDRR group. A total of 765 patients received 15 mg of rivaroxaban (203 in the HDRR group and 562 in the LDRR group). There were no significant differences in the incidence rates of major bleeding (adjusted hazard ratio [HR], 0.64; 95% confidential interval [CI], 0.21-1.93), stroke (adjusted HR, 3.21; 95% CI, 0.54-19.03), and composite outcomes (adjusted HR, 1.13; 95% CI, 0.47-2.69) between the HDRR and LDRR groups.

conclusionThis study revealed the safety and effectiveness of either dose regimen of rivaroxaban in an Asian population for stroke prevention of AF. Considerable numbers of patients are receiving LDRR therapy in real-world practice in Asia. Both regimens were safe and effective for these patients.

trial registrationClinicalTrials.gov Identifier: NCT04096547.

Indexed as

Atrial FibrillationStrokeAgedEast Asian PeopleFemaleHumansMaleProspective StudiesRivaroxabanRivaroxabanAsianAtrial FibrillationBleedingRivaroxaban Dose RegimenStroke

Identifiers

PMID38442717
PMCPMC10911935
OpenAlexW4391827563

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.