Evidence map›Paper›PMID 40958621›Full record

Trial reportEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2025

VARC-HBR criteria validation in TAVI patients on oral anticoagulation.

Daniël C Overduin, Dirk Jan van Ginkel, Willem L Bor, Yusuke Kobari, Hugo M Aarts, Christophe Dubois, Ole De Backer, Maxim J P Rooijakkers, Liesbeth Rosseel, Leo Veenstra and 36 more

Abstract readValidation StudyRandomized Controlled Trial
In one paragraph

Trial report in EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

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

2 citing papers in PubMed.

  1. Observational
  2. An ongoing quest to discern the optimal antithrombotic therapy after TAVI.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2025
    Article
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

46 authors.

Daniël C OverduinDepartment of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands.
Dirk Jan van GinkelDepartment of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands.
Willem L BorDepartment of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands.
Yusuke KobariThe Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Hugo M AartsDepartment of Cardiology, Amsterdam UMC, Amsterdam, the Netherlands.
Christophe DuboisDepartment of Cardiovascular Medicine, University Hospital Leuven, Leuven, Belgium.
Ole De BackerThe Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Maxim J P RooijakkersDepartment of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.
Liesbeth RosseelDepartment of Cardiology, Hartcentrum Aalst, Aalst, Belgium.
Leo VeenstraDepartment of Cardiology, Maastricht University Medical Center, Maastricht, the Netherlands.
Frank van der KleyDepartment of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.
Kees H van BergeijkDepartment of Cardiology, University Medical Center Groningen, Groningen, the Netherlands.
Nicolas M van MieghemDepartment of Cardiology, Erasmus University Medical Center, Rotterdam, the Netherlands.
Pierfrancesco AgostoniDepartment of Cardiology, Hospital Aan de Stroom (ZAS) Middelheim, Antwerp, Belgium.
Michiel VoskuilDepartment of Cardiology, University Medical Center Utrecht, Utrecht, the Netherlands.
Carl E SchotborghDepartment of Cardiology, Haga Hospital, The Hague, the Netherlands.
Alexander J J IjsselmuidenDepartment of Cardiology, Maastricht University Medical Center, Maastricht, the Netherlands.
Jan A S Van HeydenDepartment of Cardiology, Sint-Jan Hospital, Brugge, Belgium.
Renicus S HermanidesDepartment of Cardiology, Isala Hospital, Zwolle, the Netherlands.
Emanuele BarbatoDepartment of Clinical and Molecular Medicine, Sapienza University of Rome, Rome, Italy.
Darren MylotteDepartment of Cardiology, University Hospital Galway, Galway, Ireland.
Enrico FabrisCardiothoracovascular Department, University of Trieste, Trieste, Italy.
Peter FrambachDepartment of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg.
Karl DujardinDepartment of Cardiology, AZ Delta, Roeselare, Belgium.
Bert FerdinandeDepartment of Cardiology, Hospital Oost-Limburg, Genk, Belgium.
Joyce PeperDepartment of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands.
Benno J W M RensingDepartment of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands.
Leo TimmersDepartment of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands.
Martin J SwaansDepartment of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands.
Jorn BrouwerDepartment of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands.
Vincent J NijenhuisDepartment of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands.
Tom AdriaenssensDepartment of Cardiovascular Medicine, University Hospital Leuven, Leuven, Belgium.
Pieter A VriesendorpDepartment of Cardiology, Maastricht University Medical Center, Maastricht, the Netherlands.
Jose M Montero-CabezasDepartment of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.
Hicham El JattariDepartment of Cardiology, Hospital Aan de Stroom (ZAS) Middelheim, Antwerp, Belgium.
Jonathan HalimDepartment of Cardiology, Elisabeth-Tweesteden Hospital, Tilburg, the Netherlands.
Ben J L Van den BrandenDepartment of Cardiology, Amphia Hospital, Breda, the Netherlands.
Remigio LeonoraDepartment of Cardiology, Isala Hospital, Zwolle, the Netherlands.
Marc VanderheydenDepartment of Cardiology, Hartcentrum Aalst, Aalst, Belgium.
Michael LauterbachDepartment of Cardiology, AZ Delta, Roeselare, Belgium.
Joanna J WykrzykowskaDepartment of Cardiology, University Medical Center Groningen, Groningen, the Netherlands.
Arnoud W J van 't HofDepartment of Cardiology, Maastricht University Medical Center, Maastricht, the Netherlands.
Niels van RoyenDepartment of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.
Jan G P TijssenDepartment of Cardiology, Amsterdam UMC, Amsterdam, the Netherlands.
Ronak DelewiDepartment of Cardiology, Amsterdam UMC, Amsterdam, the Netherlands.
Jurriën M Ten BergDepartment of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBleeding remains a frequent complication after transcatheter aortic valve implantation (TAVI). Recently, the Valve Academic Research Consortium High Bleeding Risk (VARC-HBR) criteria were introduced to identify patients at (very) high risk of bleeding.

aimsThis study aimed to evaluate the validity of the VARC-HBR criteria for predicting bleeding risk in TAVI patients and to compare its performance with other existing criteria.

methodsData were obtained from the POPular PAUSE TAVI trial, a randomised clinical trial that evaluated the safety and efficacy of continuation versus interruption of oral anticoagulation during TAVI. Major and minor bleeding risk criteria were identified at baseline, and bleeding events were recorded up to 30 days after TAVI. Patients were classified into three groups: those with ≤1 minor criterion (moderate risk), those with 1 major or 2 minor criteria (high risk), and those with ≥2 major or ≥3 minor criteria (very high risk).

resultsA total of 856 patients were included: 332 (39%) were classified at moderate bleeding risk, 337 (39%) at high bleeding risk, and 187 (22%) at very high bleeding risk. Major bleeding occurred in 4.2% of moderate-risk patients, 9.5% in the high-risk group, and 15.0% in the very high-risk group (p<0.001). Receiver operating characteristic analysis showed moderate discriminative performance (area under the curve=0.64, 95% confidence interval: 0.58-0.70). Despite higher-than-expected event rates, the VARC-HBR criteria demonstrated good calibration with observed outcomes.

conclusionsThe VARC-HBR criteria effectively identified distinct subgroups with a stepwise increase in major bleeding post-TAVI. However, their predictive performance for individual risk was moderate.

Indexed as

AnticoagulantsAortic Valve StenosisHemorrhageTranscatheter Aortic Valve ReplacementAdministration, OralAgedAged, 80 and overFemaleHumansMaleRisk AssessmentRisk FactorsTreatment OutcomeAnticoagulants

Identifiers

PMID40958621
PMCPMC12418106

What Socratic holds

Textmetadata
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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 Socratic graph.