Evidence map›Paper›PMID 31888928›Full record

ArticleBMJ open2019

Safety of switching from vitamin K antagonist to non-vitamin K antagonist oral anticoagulant in frail elderly with atrial fibrillation: rationale and design of the FRAIL-AF randomised controlled trial.

Linda P T Joosten, Sander van Doorn, Arno W Hoes, Melchior C Nierman, Nynke M Wiersma, Huiberdina L Koek, Martin E W Hemels, Menno V Huisman, Kit C Roes, Rutger M van den Bor and 3 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.6field-weighted citation impact, top 9% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 21 citations in OpenAlex.

  1. Review
  2. Review
  3. Anticoagulants in frail elderly patients with atrial fibrillation: a delicate balance.Research and practice in thrombosis and haemostasis · 2023
    Article
  4. Article
  5. Atrial fibrillation: trends in prevalence and antithrombotic prescriptions in the community.Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2022
    Article
  6. Article
  7. Non-vitamin K antagonist oral anticoagulants in older and frail patients with atrial fibrillation.European heart journal supplements : journal of the European Society of Cardiology · 2022
    Article
  8. Article
  9. Antithrombotic management of patients with atrial fibrillation-Dutch anticoagulant initiatives anno 2020.Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2020
    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

13 authors at 3 institutions in 1 country.

Linda P T JoostenJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands l.p.t.joosten-3@umcutrecht.nl.ORCID 0000-0002-0926-9749
Sander van DoornJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.ORCID 0000-0003-4319-3503
Arno W HoesJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Melchior C NiermanDepartment of Thrombosis and Anticoagulation, Atalmedial Medical Diagnostics Centers, Amsterdam, The Netherlands.
Nynke M WiersmaDepartment of Thrombosis and Anticoagulation, Diagnostic Center Saltro, Utrecht, The Netherlands.
Huiberdina L KoekDepartment of Geriatrics, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Martin E W HemelsDepartment of Cardiology, Rijnstate Hospital, Arnhem, The Netherlands.
Menno V HuismanDepartment of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden University, Leiden, The Netherlands.
Kit C RoesJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Rutger M van den BorJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Wim F BudingMember of the Dutch Organisation for patients using anticoagulant medication, CTD Nederland, Leiden, The Netherlands.
Frans H RuttenJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Geert-Jan GeersingJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Utrecht University · NLLeiden University Medical Center · NLRadboud University Nijmegen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionClinical guidelines recommend non-vitamin K antagonist oral anticoagulants (NOACs) over vitamin K antagonists (VKAs) for stroke prevention in most patients with atrial fibrillation (AF). Frail elderly were under-represented in the landmark NOAC-trials, leaving a knowledge gap on the optimal anticoagulant management (VKA or NOAC) in this increasing population. The aim of the Frail-AF (FRAIL-AF) study is to assess whether switching from international normalised ratio (INR)-guided VKA-management to a NOAC-based treatment strategy compared with continuing VKA-management is safe in frail elderly patients with AF. METHODS AND ANALYSIS: The FRAIL-AF study is a pragmatic, multicentre, open-label, randomised controlled clinical trial. Frail elderly (age ≥75 years plus a Groningen Frailty Indicator score ≥3) who receive VKA-treatment for AF in the absence of a mechanical heart valve or severe mitral valve stenosis will be randomised to switch to a NOAC-based treatment strategy or to continue INR-guided VKA-management. Patients with severe renal impairment (estimated glomerular filtration rate <30 mL/min/1.73 m ETHICS AND DISSEMINATION: The protocol was approved by the Medical Research Ethics Committee of the University Medical Center Utrecht, the Netherlands and by the Central Committee on Research Involving Human Subjects, the Netherlands. All patients are asked written informed consent. Results are expected in 2022 and will be disseminated through peer-reviewed journals as well as presentations at national and international conferences. TRIAL REGISTRATION NUMBER: EudraCT: 2017-000393-11; The Netherlands Trial Registry: 6721 (FRAIL-AF study).

Indexed as

AnticoagulantsAtrial FibrillationFrail ElderlyVitamin KAdministration, OralAgedFemaleHumansMaleMiddle AgedMulticenter Studies as TopicPragmatic Clinical Trials as TopicStrokeAnticoagulantsVitamin Kanticoagulationatrial fibrillationbleedingelderlyfrailopen-label

Identifiers

PMID31888928
PMCPMC6937027
OpenAlexW2996784933

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.