Evidence map›Paper›PMID 41128170›Full record

Trial reportJournal of the American Heart Association2025

Sex Differences in Transcatheter Aortic Valve Implantation Outcomes in Patients on Oral Anticoagulants: A Popular PAUSE TAVI SubAnalysis.

Kees H van Bergeijk, Daniël C Overduin, Constantijn S Venema, Dirk Jan van Ginkel, Hindrik W van der Werf, Ad F M van den Heuvel, Adriaan A Voors, Joanna J Wykrzykowska, Jurrien M Ten Berg

Registry-linked trialAbstract readClinical Trial, Phase IVComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the American Heart Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04437303 (Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT04437303 phase4completednot on this map

Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI)

TypeinterventionalSponsorSt. Antonius HospitalRan2020 to 2024Enrolled858ConditionsAortic Valve Disease, Aortic Valve Stenosis, Stroke, BleedingArmsContinuation of oral anticoagulants, Interruption of oral anticoagulants
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

9 authors.

Kees H van BergeijkDepartment of Cardiology University of Groningen, University Medical Center Groningen the Netherlands.ORCID 0000-0001-6271-0567
Daniël C OverduinDepartment of Cardiology St. Antonius Hospital Nieuwegein the Netherlands.
Constantijn S VenemaDepartment of Cardiology University of Groningen, University Medical Center Groningen the Netherlands.ORCID 0000-0002-6273-9287
Dirk Jan van GinkelDepartment of Cardiology St. Antonius Hospital Nieuwegein the Netherlands.
Hindrik W van der WerfDepartment of Cardiology University of Groningen, University Medical Center Groningen the Netherlands.ORCID 0009-0003-5441-2668
Ad F M van den HeuvelDepartment of Cardiology University of Groningen, University Medical Center Groningen the Netherlands.ORCID 0000-0002-0385-0524
Adriaan A VoorsDepartment of Cardiology University of Groningen, University Medical Center Groningen the Netherlands.ORCID 0000-0002-5417-4415
Joanna J WykrzykowskaDepartment of Cardiology University of Groningen, University Medical Center Groningen the Netherlands.ORCID 0000-0001-7577-4084
Jurrien M Ten BergDepartment of Cardiology St. Antonius Hospital Nieuwegein the Netherlands.ORCID 0000-0001-5192-886X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMany patients undergoing transcatheter aortic valve implantation (TAVI) have an indication for oral anticoagulation (OAC). Our aim was to study sex differences in outcomes after TAVI, depending on the type and regimen of vitamin K antagonist versus direct OAC.

methodsThe Popular PAUSE TAVI (Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation) was a randomized clinical trial to compare outcomes between patients who continued or interrupted OAC during TAVI. The outcomes of interest in this subanalysis were a combination of cardiovascular mortality, stroke, myocardial infarction, major vascular complications or major bleeding at 30 days, stratified by OAC regimen and type, and sex.

resultsAfter 30 days of follow-up, 44/296 (14.9%) women reached the combined end point, compared with 90/562 men (16.0%),

conclusionsAfter a 30-day follow-up of patients undergoing TAVI on OAC, there were no statistically significant differences in outcomes between sexes, independent of interrupted or continued management. Although women treated with vitamin K antagonist had numerically more events than those with direct OAC and an interaction between sex and type of OAC was present, this interaction lost significance after adjustment for other factors. REGISTRATION: https://clinicaltrials.gov/study/NCT04437303; Unique Identifier: NCT044373030.

Indexed as

AnticoagulantsAortic Valve StenosisStrokeTranscatheter Aortic Valve ReplacementAdministration, OralAgedAged, 80 and overFemaleHemorrhageHumansMaleRisk FactorsSex FactorsTime FactorsTreatment OutcomeVitamin KAnticoagulantsVitamin Kbleedingischemic outcomesoral anticoagulantssex differencesTAVI

Identifiers

PMID41128170
PMCPMC12684620

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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.