Evidence map›Paper›PMID 36335914›Full record

Trial reportCirculation2022

Apixaban for Patients With Atrial Fibrillation on Hemodialysis: A Multicenter Randomized Controlled Trial.

Sean D Pokorney, Glenn M Chertow, Hussein R Al-Khalidi, Dianne Gallup, Pat Dignacco, Kurt Mussina, Nisha Bansal, Crystal A Gadegbeku, David A Garcia, Samira Garonzik and 12 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Circulation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02942407 (RENal Hemodialysis Patients ALlocated Apixaban Versus Warfarin in Atrial Fibrillation), which is not on this map. Cited by 123 papers, 19 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
123citing papers in PubMed, 19 pooled it
32.0field-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.

NCT02942407 phase4completednot on this map

RENal Hemodialysis Patients ALlocated Apixaban Versus Warfarin in Atrial Fibrillation (RENAL-AF) Randomized Clinical Trial

TypeinterventionalSponsorChristopher Granger, MDRan2016 to 2019Enrolled154ConditionsAtrial Fibrillation, End Stage Renal DiseaseArmsapixaban, warfarin
3 · Its place in the literature

Who cites it

123 citing papers in PubMed, 19 syntheses or guidelines pooled it, 210 citations in OpenAlex.

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  6. Left atrial appendage occlusion in patients with end-stage renal disease: an individual patient-level meta-analysis.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
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  9. 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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  14. Anticoagulation for people receiving long-term haemodialysis.The Cochrane database of systematic reviews · 2024
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  15. Guideline
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  18. 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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63 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 8 institutions in 4 countries.

Sean D PokorneyDuke Clinical Research Institute, Duke University Medical Center, Durham, NC (S.D.P., H.R.A.-K., D.G., P.D., R.D.L., J.P.M., J.A.R., K.L.T., J.B.W., C.B.G.).ORCID 0000-0002-4345-0816
Glenn M ChertowStanford University, Palo Alto, CA (G.M.C., K.W.M., K.M.).
Hussein R Al-KhalidiDuke Clinical Research Institute, Duke University Medical Center, Durham, NC (S.D.P., H.R.A.-K., D.G., P.D., R.D.L., J.P.M., J.A.R., K.L.T., J.B.W., C.B.G.).ORCID 0000-0003-1375-0487
Dianne GallupDuke Clinical Research Institute, Duke University Medical Center, Durham, NC (S.D.P., H.R.A.-K., D.G., P.D., R.D.L., J.P.M., J.A.R., K.L.T., J.B.W., C.B.G.).
Pat DignaccoDuke Clinical Research Institute, Duke University Medical Center, Durham, NC (S.D.P., H.R.A.-K., D.G., P.D., R.D.L., J.P.M., J.A.R., K.L.T., J.B.W., C.B.G.).
Kurt MussinaStanford University, Palo Alto, CA (G.M.C., K.W.M., K.M.).
Nisha BansalUniversity of Washington, Seattle (N.B., D.A.G.).
Crystal A GadegbekuTemple University, Philadelphia, PA (C.A.G.).
David A GarciaUniversity of Washington, Seattle (N.B., D.A.G.).
Samira GaronzikBristol Myers-Squibb, Princeton, NJ (S.G.).
Renato D LopesDuke Clinical Research Institute, Duke University Medical Center, Durham, NC (S.D.P., H.R.A.-K., D.G., P.D., R.D.L., J.P.M., J.A.R., K.L.T., J.B.W., C.B.G.).ORCID 0000-0003-2999-4961
Kenneth W MahaffeyStanford University, Palo Alto, CA (G.M.C., K.W.M., K.M.).
Kelly MatsudaStanford University, Palo Alto, CA (G.M.C., K.W.M., K.M.).
John P MiddletonDuke Clinical Research Institute, Duke University Medical Center, Durham, NC (S.D.P., H.R.A.-K., D.G., P.D., R.D.L., J.P.M., J.A.R., K.L.T., J.B.W., C.B.G.).
Jennifer A RymerDuke Clinical Research Institute, Duke University Medical Center, Durham, NC (S.D.P., H.R.A.-K., D.G., P.D., R.D.L., J.P.M., J.A.R., K.L.T., J.B.W., C.B.G.).ORCID 0000-0001-9841-2393
George H SandsPfizer, New York, NY (G.H.S.).
Ravi ThadhaniMassachussetts General and Brigham and Women's Hospitals, Boston (R.T.).
Kevin L ThomasDuke Clinical Research Institute, Duke University Medical Center, Durham, NC (S.D.P., H.R.A.-K., D.G., P.D., R.D.L., J.P.M., J.A.R., K.L.T., J.B.W., C.B.G.).ORCID 0000-0002-0040-5396
Jeffrey B WashamDuke Clinical Research Institute, Duke University Medical Center, Durham, NC (S.D.P., H.R.A.-K., D.G., P.D., R.D.L., J.P.M., J.A.R., K.L.T., J.B.W., C.B.G.).
Wolfgang C WinkelmayerBaylor College of Medicine, Houston, TX (W.C.W.).
Christopher B GrangerDuke Clinical Research Institute, Duke University Medical Center, Durham, NC (S.D.P., H.R.A.-K., D.G., P.D., R.D.L., J.P.M., J.A.R., K.L.T., J.B.W., C.B.G.).ORCID 0000-0002-0045-3291
RENAL-AF Investigators
Duke University · USPalo Alto University · USUniversity of Washington · USBaylor College of Medicine · USBrigham and Women's Hospital · USBristol-Myers Squibb (Germany) · DEPfizer (United States) · USTemple University · US

Funding

The Atrial Fibrillation - Factor Identification to Risk Modification Study in HDR01DK095024 · NIDDK · STANFORD UNIVERSITY · PI WINKELMAYER, WOLFGANG CHRISTOPH · 2012 to 2023
$4.3M
6 · The paper itself

Abstract

backgroundThere are no randomized data evaluating the safety or efficacy of apixaban for stroke prevention in patients with end-stage kidney disease on hemodialysis and with atrial fibrillation (AF).

methodsThe RENAL-AF trial (Renal Hemodialysis Patients Allocated Apixaban Versus Warfarin in Atrial Fibrillation) was a prospective, randomized, open-label, blinded-outcome evaluation (PROBE) of apixaban versus warfarin in patients receiving hemodialysis with AF and a CHA

resultsFrom January 2017 through January 2019, 154 patients were randomly assigned to apixaban (n=82) or warfarin (n=72). The trial stopped prematurely because of enrollment challenges. Time in therapeutic range (international normalized ratio, 2.0-3.0) for warfarin-treated patients was 44% (interquartile range, 23%-59%). The 1-year rates for major or clinically relevant nonmajor bleeding were 32% and 26% in apixaban and warfarin groups, respectively (hazard ratio, 1.20 [95% CI, 0.63-2.30]), whereas 1-year rates for stroke or systemic embolism were 3.0% and 3.3% in apixaban and warfarin groups, respectively. Death was the most common major event in the apixaban (21 patients [26%]) and warfarin (13 patients [18%]) arms. The pharmacokinetic substudy enrolled the target 50 patients. Median steady-state 12-hour area under the curve was 2475 ng/mL×h (10th to 90th percentiles, 1342-3285) for 5 mg of apixaban twice daily and 1269 ng/mL×h (10th to 90th percentiles, 615-1946) for 2.5 mg of apixaban twice daily. There was substantial overlap between minimum apixaban blood concentration, 12-hour area under the curve, and maximum apixaban blood concentration for patients with and without a major or clinically relevant nonmajor bleeding event.

conclusionsThere was inadequate power to draw any conclusion regarding rates of major or clinically relevant nonmajor bleeding comparing apixaban and warfarin in patients with AF and end-stage kidney disease on hemodialysis. Clinically relevant bleeding events were ≈10-fold more frequent than stroke or systemic embolism among this population on anticoagulation, highlighting the need for future randomized studies evaluating the risks versus benefits of anticoagulation among patients with AF and end-stage kidney disease on hemodialysis. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02942407.

Indexed as

Atrial FibrillationEmbolismKidney Failure, ChronicStrokeAnticoagulantsHemorrhageHumansProspective StudiesPyrazolesPyridonesRenal DialysisTreatment OutcomeWarfarinAnticoagulantsapixabanPyrazolesPyridonesWarfarinanticoagulantsapixabanatrial fibrillationkidney failure, chronicrenal dialysiswarfarin

Identifiers

PMID36335914
OpenAlexW4308365855

What OpenQuestion holds

Textmetadata
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.