Evidence map›Paper›PMID 37596725›Full record

ArticleClinical cardiology2023

Predictors of intracranial hemorrhage in patients with atrial fibrillation treated with oral anticoagulants: Insights from the GARFIELD-AF and ORBIT-AF registries.

Toon Wei Lim, Alan John Camm, Saverio Virdone, Daniel E Singer, Jean P Bassand, Gregg C Fonarow, Keith A A Fox, Michael Ezekowitz, Bernard J Gersh, Gloria Kayani and 7 more

Open access · goldAbstract read
In one paragraph

Article in Clinical cardiology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.3field-weighted citation impact, top 17% 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

5 citing papers in PubMed, 6 citations in OpenAlex.

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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

17 authors at 13 institutions in 4 countries.

Toon Wei LimNational Heart Centre, Singapore, Singapore.ORCID http://orcid.org/0000-0002-3429-9237
Alan John CammCardiology Clinical Academic Group Molecular & Clinical Sciences Institute, St. George's University of London, London, UK.ORCID http://orcid.org/0000-0002-2536-2871
Saverio VirdoneThrombosis Research Institute, London, UK.
Daniel E SingerMassachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Jean P BassandThrombosis Research Institute, London, UK.
Gregg C FonarowRonald Reagan-UCLA Medical Center, Los Angeles, California, USA.ORCID http://orcid.org/0000-0002-3192-8093
Keith A A FoxDepartment of Cardiovascular Science, Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.
Michael EzekowitzSidney Kimmel Medical School, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Bernard J GershMayo Clinic College of Medicine and Science, Rochester, Minnesota, USA.
Gloria KayaniThrombosis Research Institute, London, UK.
Elaine M HylekDepartment of Medicine, Boston University School of Medicine, Boston, Massachusetts, USA.
Ajay K KakkarThrombosis Research Institute, London, UK.
Kenneth W MahaffeyStanford Center for Clinical Research, Stanford School of Medicine, Stanford, California, USA.
Karen S PieperThrombosis Research Institute, London, UK.
Eric D PetersonDepartment of Cardiac Electrophysiology, Duke Clinical Research Institute, Durham, North Carolina, USA.
Jonathan P PicciniDepartment of Cardiac Electrophysiology, Duke Clinical Research Institute, Durham, North Carolina, USA.ORCID http://orcid.org/0000-0003-0772-2404
GARFIELD-AF and ORBIT-AF Investigators
Thrombosis Research Institute · GBDuke University · USBoston University · USCentre Hospitalier Universitaire de Besançon · FRClinical Research Institute · USHarvard University · USMayo Clinic · USNational University Hospital · SGRonald Reagan UCLA Medical Center · USStanford Medicine · USSt George's, University of London · GBThomas Jefferson University · USUniversity of Edinburgh · GB

Funding

Janssen Scientific Affairs LLCThrombosis Research Institute
6 · The paper itself

Abstract

backgroundAn unmet need exists to reliably predict the risk of intracranial hemorrhage (ICH) in patients with atrial fibrillation (AF) treated with oral anticoagulants (OACs). HYPOTHESIS: An externally validated model improves ICH risk stratification.

methodsIndependent factors associated with ICH were identified by Cox proportional hazard modeling, using pooled data from the GARFIELD-AF (Global Anticoagulant Registry in the FIELD-Atrial Fibrillation) and ORBIT-AF (Outcomes Registry for Better Informed Treatment of Atrial Fibrillation) registries. A predictive model was developed and validated by bootstrap sampling and by independent data from the Danish National Patient Register.

resultsIn the combined training data set, 284 of 53 878 anticoagulated patients had ICH over a 2-year period (0.31 per 100 person-years; 95% confidence interval [CI]: 0.28-0.35). Independent predictors of ICH included: older age, prior stroke or transient ischemic attack, concomitant antiplatelet (AP) use, and moderate-to-severe chronic kidney disease (CKD). Vitamin K antagonists (VKAs) were associated with a significantly higher risk of ICH compared with non-VKA oral anticoagulants (NOACs) (adjusted hazard ratio: 1.61; 95% CI: 1.25-2.08; p = .0002). The ability of the model to discriminate individuals in the training set with and without ICH was fair (optimism-corrected C-statistic: 0.68; 95% CI: 0.65-0.71) and outperformed three previously published methods. Calibration between predicted and observed ICH probabilities was good in both training and validation data sets.

conclusionsAge, prior ischemic events, concomitant AP therapy, and CKD were important risk factors for ICH in anticoagulated AF patients. Moreover, ICH was more frequent in patients receiving VKA compared to NOAC. The new validated model is a step toward mitigating this potentially lethal complication.

Indexed as

Atrial FibrillationRenal Insufficiency, ChronicStrokeAdministration, OralAnticoagulantsHumansIntracranial HemorrhagesRegistriesRisk FactorsVitamin KAnticoagulantsVitamin Kanticoagulationatrial fibrillation (AF)chronic kidney diseaseintracranial hemorrhage (ICH)nonvitamin K antagonist (NOAC)oral anticoagulant (OAC)real-world evidence (RWE)risk predictionvitamin K antagonist (VKA)

Identifiers

PMID37596725
PMCPMC10642328
OpenAlexW4385997414

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.