Evidence map›Paper›PMID 25595139›Full record

ArticleCirculation2015

Dabigatran and rivaroxaban use in atrial fibrillation patients on hemodialysis.

Kevin E Chan, Elazer R Edelman, Julia B Wenger, Ravi I Thadhani, Franklin W Maddux

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Circulation, 2015. 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 120 papers, 21 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
120citing papers in PubMed, 21 pooled it
–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.

NCT02942407 phase4completednot on this mapstarted 2016, after this paper: background citation

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

120 citing papers in PubMed, 21 syntheses or guidelines pooled it.

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60 more citing papers are in PubMed but not listed here.

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

5 authors.

Kevin E ChanFrom Nephrology Division, Massachusetts General Hospital, Waltham, MA (K.E.C., J.B.W., R.I.T.); Clinical Research Division, Fresenius Medical Care North America, Waltham, MA (K.E.C., F.W.M.); Massachusetts Institute of Technology, Harvard-MIT Biomedical Engineering Center, Institute for Medical Engineering and Science, Cambridge, MA (E.R.E.); and Cardiovascular Medicine Division, Brigham and Women's Hospital, Boston, MA (E.R.E.). kevin.chan@fmc-na.com.
Elazer R EdelmanFrom Nephrology Division, Massachusetts General Hospital, Waltham, MA (K.E.C., J.B.W., R.I.T.); Clinical Research Division, Fresenius Medical Care North America, Waltham, MA (K.E.C., F.W.M.); Massachusetts Institute of Technology, Harvard-MIT Biomedical Engineering Center, Institute for Medical Engineering and Science, Cambridge, MA (E.R.E.); and Cardiovascular Medicine Division, Brigham and Women's Hospital, Boston, MA (E.R.E.).
Julia B WengerFrom Nephrology Division, Massachusetts General Hospital, Waltham, MA (K.E.C., J.B.W., R.I.T.); Clinical Research Division, Fresenius Medical Care North America, Waltham, MA (K.E.C., F.W.M.); Massachusetts Institute of Technology, Harvard-MIT Biomedical Engineering Center, Institute for Medical Engineering and Science, Cambridge, MA (E.R.E.); and Cardiovascular Medicine Division, Brigham and Women's Hospital, Boston, MA (E.R.E.).
Ravi I ThadhaniFrom Nephrology Division, Massachusetts General Hospital, Waltham, MA (K.E.C., J.B.W., R.I.T.); Clinical Research Division, Fresenius Medical Care North America, Waltham, MA (K.E.C., F.W.M.); Massachusetts Institute of Technology, Harvard-MIT Biomedical Engineering Center, Institute for Medical Engineering and Science, Cambridge, MA (E.R.E.); and Cardiovascular Medicine Division, Brigham and Women's Hospital, Boston, MA (E.R.E.).
Franklin W MadduxFrom Nephrology Division, Massachusetts General Hospital, Waltham, MA (K.E.C., J.B.W., R.I.T.); Clinical Research Division, Fresenius Medical Care North America, Waltham, MA (K.E.C., F.W.M.); Massachusetts Institute of Technology, Harvard-MIT Biomedical Engineering Center, Institute for Medical Engineering and Science, Cambridge, MA (E.R.E.); and Cardiovascular Medicine Division, Brigham and Women's Hospital, Boston, MA (E.R.E.).

Funding

Vascular Drug Delivery - Supplement for EquipmentR01GM049039 · NIGMS · MASSACHUSETTS INSTITUTE OF TECHNOLOGY · PI EDELMAN, ELAZER R · 1994 to 2019
$8.9M
NIGMS NIH HHS R01 GM049039NIGMS NIH HHS R01 GM 49039
6 · The paper itself

Abstract

backgroundDabigatran and rivaroxaban are new oral anticoagulants that are eliminated through the kidneys. Their use in dialysis patients is discouraged because these drugs can bioaccumulate to precipitate inadvertent bleeding. We wanted to determine whether prescription of dabigatran or rivaroxaban was occurring in the dialysis population and whether these practices were safe. METHODS AND

resultsPrevalence plots were used to describe the point prevalence (monthly) of dabigatran and rivaroxaban use among 29977 hemodialysis patients with atrial fibrillation. Poisson regression compared the rate of bleeding, stroke, and arterial embolism in patients who started dabigatran, rivaroxaban, or warfarin. The first record of dabigatran prescription among hemodialysis patients occurred 45 days after the drug became available in the United States. Since then, dabigatran and rivaroxaban use in the atrial fibrillation-end-stage renal disease population has steadily risen where 5.9% of anticoagulated dialysis patients are started on dabigatrian or rivaroxaban. In covariate adjusted Poisson regression, dabigatran (rate ratio, 1.48; 95% confidence interval, 1.21-1.81; P=0.0001) and rivaroxaban (rate ratio, 1.38; 95% confidence interval, 1.03-1.83; P=0.04) associated with a higher risk of hospitalization or death from bleeding when compared with warfarin. The risk of hemorrhagic death was even larger with dabigatran (rate ratio, 1.78; 95% confidence interval, 1.18-2.68; P=0.006) and rivaroxaban (rate ratio, 1.71; 95% confidence interval, 0.94-3.12; P=0.07) relative to warfarin. There were too few events in the study to detect meaningful differences in stroke and arterial embolism between the drug groups.

conclusionsMore dialysis patients are being started on dabigatran and rivaroxaban, even when their use is contraindicated and there are no studies to support that the benefits outweigh the risks of these drugs in end-stage renal disease.

Indexed as

Renal DialysisAgedAged, 80 and overAnticoagulantsAtrial FibrillationBenzimidazolesbeta-AlanineDabigatranDatabases, FactualDose-Response Relationship, DrugDrug UtilizationFemaleHemorrhageHospitalizationHumansKidneyAnticoagulantsBenzimidazolesbeta-AlanineDabigatranMorpholinesRivaroxabanThiophenesWarfarinatrial fibrillationdabigatrandialysisrivaroxabanwarfarin

Identifiers

PMID25595139
PMCPMC4363265

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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.