Evidence map›Paper›PMID 36335915›Full record

Trial reportCirculation2023

A Randomized Controlled Trial Comparing Apixaban With the Vitamin K Antagonist Phenprocoumon in Patients on Chronic Hemodialysis: The AXADIA-AFNET 8 Study.

Holger Reinecke, Christiane Engelbertz, Rupert Bauersachs, Günter Breithardt, Hans-Herbert Echterhoff, Joachim Gerß, Karl Georg Haeusler, Bernd Hewing, Joachim Hoyer, Sabine Juergensmeyer and 7 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Circulation, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02933697 (A Safety Study Assessing Oral Anticoagulation With Apixaban Versus Vitamin-K Antagonists in Patients With Atrial Fibrillation), which is not on this map. Cited by 99 papers, 16 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
99citing papers in PubMed, 16 pooled it
24.6field-weighted citation impact, top 1% 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.

NCT02933697 phase3completednot on this map

A Safety Study Assessing Oral Anticoagulation With Apixaban Versus Vitamin-K Antagonists in Patients With Atrial Fibrillation (AF) and End-Stage Kidney Disease (ESKD) on Chronic Hemodialysis Treatment

TypeinterventionalSponsorAtrial Fibrillation NetworkRan2017 to 2022Enrolled108ConditionsAtrial Fibrillation, End-stage Kidney DiseaseArmsApixaban, Phenprocoumon
3 · Its place in the literature

Who cites it

99 citing papers in PubMed, 16 syntheses or guidelines pooled it, 162 citations in OpenAlex.

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  7. Transcatheter left atrial appendage occlusion in patients with chronic kidney disease: a systematic review and meta-analysis.Clinical research in cardiology : official journal of the German Cardiac Society · 2024
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  12. Anticoagulation for people receiving long-term haemodialysis.The Cochrane database of systematic reviews · 2024
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  13. Guideline
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  16. Factor Xa Inhibitors Versus Vitamin K Antagonists in Atrial Fibrillation Patients with End-Stage Kidney Disease on Dialysis: A Meta-Analysis.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Pooled it
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39 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 14 institutions in 5 countries.

Holger ReineckeKlinik für Kardiologie I: Koronare Herzkrankheit, Herzinsuffizienz und Angiologie (H.R., C.E., G.B.), Universitaetsklinikum Muenster, Germany.
Christiane EngelbertzKlinik für Kardiologie I: Koronare Herzkrankheit, Herzinsuffizienz und Angiologie (H.R., C.E., G.B.), Universitaetsklinikum Muenster, Germany.
Rupert BauersachsCCB-Cardioangiologic Center Bethanien, Frankfurt, Germany (R.B.).
Günter BreithardtKlinik für Kardiologie I: Koronare Herzkrankheit, Herzinsuffizienz und Angiologie (H.R., C.E., G.B.), Universitaetsklinikum Muenster, Germany.
Hans-Herbert EchterhoffDialysezentrum Bielefeld, Germany (H.-H.E.).
Joachim GerßInstitut für Biometrie und Klinische Forschung, Westfaelische Wilhelms-Universitaet, Muenster, Germany (J.G., D.G.).
Karl Georg HaeuslerDepartment of Neurology, Universitätsklinikum Würzburg, Germany (K.G.H.).
Bernd HewingKlinik für Kardiologie III: Angeborene Herzfehler (EMAH) und Klappenerkrankungen (B.H.), Universitaetsklinikum Muenster, Germany.
Joachim HoyerKlinik für Innere Medizin und Nephrologie, Philipps-Universitaet Marburg, Germany (J.H.).
Sabine JuergensmeyerKompetenznetz Vorhofflimmern eV, AFNET, Muenster, Germany (S.J., P.K.).
Thomas KlingenhebenPraxis für Kardiologie, Bonn, Germany (T.K.).
Guido KnappFakultaet Statistik, Technische Universitaet Dortmund, Germany (G.K.).
Lars Christian RumpDepartment of Nephrology, Medical Faculty, University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf, Germany (L.C.R.).
Hans Schmidt-GuertlerZentrum für Nieren-, Hochdruck und Stoffwechselerkrankungen, Hannover, Germany (H.S.-G.).
Christoph WannerDepartment Klinische Forschung & Epidemiologie, Deutsches Zentrums für Herzinsuffizienz and Division of Nephrology, University Hospital, Würzburg, Germany (C.W.).
Paulus Kirchhof *Kompetenznetz Vorhofflimmern eV, AFNET, Muenster, Germany (S.J., P.K.).
Dennis Goerlich *Institut für Biometrie und Klinische Forschung, Westfaelische Wilhelms-Universitaet, Muenster, Germany (J.G., D.G.).
Universitäts-Herzzentrum Freiburg-Bad Krozingen · DEUniversity of Münster · DEAtrial Fibrillation NETwork · DECochrane · GBDeutsches Herzzentrum der Charité · DEDüsseldorf University Hospital · DEJohannes Gutenberg University Mainz · DEKlinik für Schlafmedizin · CHOrthopädische Praxis · DEPhilipps University of Marburg · DEPHV Dialysezentrum · DETU Dortmund University · DEUniversität Hamburg · DEUniversitätsklinikum Würzburg · DE

Funding

British Heart Foundation PG/17/30/32961British Heart Foundation PG/20/22/35093
6 · The paper itself

Abstract

backgroundNon-vitamin K oral anticoagulants have become the standard therapy for preventing stroke and ischemic thromboembolism in most patients with atrial fibrillation (AF). The effectiveness and safety of non-vitamin K oral anticoagulants in patients on hemodialysis is not well known.

methodsFrom June 2017 through May 2022, AXADIA-AFNET 8 (Compare Apixaban and Vitamin K Antagonists in Patients With Atrial Fibrillation and End-Stage Kidney Disease), an investigator-initiated PROBE (prospective randomized open blinded end point) outcome assessment trial, randomized patients with AF on chronic hemodialysis to either apixaban (2.5 mg BID) or the vitamin K antagonist (VKA) phenprocoumon (international normalized ratio, 2.0 to 3.0). The composite primary safety outcome was defined by a first event of major bleeding, clinically relevant nonmajor bleeding, or all-cause death. The primary efficacy outcome was a composite of ischemic stroke, all-cause death, myocardial infarction, and deep vein thrombosis or pulmonary embolism. Our hypothesis was that apixaban is noninferior to VKA.

resultsThirty-nine sites randomized 97 patients (30% women; mean age 75 years; mean CHA

conclusionsIn this randomized trial comparing apixaban and VKA in patients with AF on hemodialysis with long follow-up, no differences were observed in safety or efficacy outcomes. Even on oral anticoagulation, patients with AF on hemodialysis remain at high risk of cardiovascular events. Larger randomized trials are needed to determine the optimal anticoagulation regimen for patients with AF on hemodialysis. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02933697.

Indexed as

Atrial FibrillationMyocardial InfarctionStrokeAgedAnticoagulantsFemaleHemorrhageHumansMalePhenprocoumonProspective StudiesPyrazolesPyridonesRenal DialysisTreatment OutcomeAnticoagulantsapixabanPhenprocoumonPyrazolesPyridonesatrial fibrillationrandomized controlled trialrenal dialysisstroke

Identifiers

PMID36335915
PMCPMC9875840
OpenAlexW4308291624

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.