Evidence map›Paper›PMID 38294497›Full record

Trial reportClinical research in cardiology : official journal of the German Cardiac Society2025

Outcomes after TAVI in patients with atrial fibrillation and a history of recent PCI: Results from the ENVISAGE-TAVI AF trial.

Raúl Moreno, José Souza, Rüdiger Smolnik, Luis Nombela-Franco, Nicolas M Van Mieghem, Christian Hengstenberg, Marco Valgimigli, James Jin, Patrick Ohlmann, George Dangas and 2 more

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Clinical research in cardiology : official journal of the German Cardiac Society, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

12 authors.

Raúl MorenoInterventional Cardiology, University Hospital La Paz, Paseo La Castellana, 261, 28046, Madrid, Spain. raulmorenog@hotmail.com.
José SouzaDaiichi Sankyo, Inc., Munich, Germany.
Rüdiger SmolnikDaiichi Sankyo, Inc., Munich, Germany.
Luis Nombela-FrancoInterventional Cardiology, Hospital Clinico San Carlos, Madrid, Spain.
Nicolas M Van MieghemDepartment of Cardiology, Erasmus University Medical Centre, Thoraxcenter, Rotterdam, the Netherlands.
Christian HengstenbergDepartment of Internal Medicine II, Division of Cardiology, Vienna General Hospital, Medical University, Vienna, Austria.
Marco ValgimigliDivision of Cardiology, Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università Della Svizzera Italiana (USI) and University of Berne, Berne, Switzerland.
James JinDaiichi Sankyo, Inc, Basking Ridge, NJ, USA.
Patrick OhlmannDivision of Cardiovascular Medicine, University Hospital of Strasbourg, Strasbourg, France.
George DangasMount Sinai Hospital, Zena and Michael A. Wiener Cardiovascular Institute, New York, NY, USA.
Martin UnverdorbenDaiichi Sankyo, Inc, Basking Ridge, NJ, USA.
Helge MöllmannDepartment of Internal Medicine, St. Johannes Hospital, Dortmund, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with atrial fibrillation (AF) and a recent (≤ 90 days) percutaneous coronary intervention (PCI) undergoing transcatheter aortic valve implantation (TAVI) are at high bleeding risk due to the addition of oral antiplatelet (OAP) agents on top of oral anticoagulants. Data on outcomes of these patients are needed to optimize antithrombotic treatment.

methodsThis analysis compared annualized clinical event rates in patients with and without a recent PCI enrolled in ENVISAGE-TAVI AF, a prospective, randomized, open-label, adjudicator-masked trial comparing edoxaban and vitamin K antagonists in AF patients after TAVI. The primary efficacy and safety outcomes were net adverse clinical events (NACE) and major bleeding.

resultsOverall, 132 (94.3%) patients with a recent PCI (n = 140) received OAP after TAVI, compared with 692 (55.9%) patients without a recent PCI (n = 1237). Among patients with a recent PCI on OAP agents, use of dual antiplatelet therapy decreased to 5.5%, and use of single antiplatelet therapy (SAPT) increased to 78.0% over 3 months post-randomization. Conversely, use of SAPT predominated at all time points in patients without a recent PCI history. There were no significant differences in the incidence of NACE or other outcomes assessed, except for major bleeding events, which were more frequent in patients with vs without a recent PCI history (hazard ratio [95% confidence interval]: 2.17 [1.27, 3.73]; P = 0.005).

conclusionsPatients with AF undergoing TAVI with a recent PCI have a similar risk of ischemic events and mortality, but an increased risk of major bleeding compared with patients without a recent PCI.

Indexed as

Aortic Valve StenosisAtrial FibrillationPercutaneous Coronary InterventionPlatelet Aggregation InhibitorsPyridinesThiazolesTranscatheter Aortic Valve ReplacementAdministration, OralAgedAged, 80 and overAnticoagulantsFactor Xa InhibitorsFemaleFollow-Up StudiesHemorrhageHumansAnticoagulantsedoxabanFactor Xa InhibitorsPlatelet Aggregation InhibitorsPyridinesThiazolesAntiplatelet therapyAtrial fibrillationEdoxabanPercutaneous coronary interventionTranscatheter aortic valve replacement

Identifiers

PMID38294497
PMCPMC11914355

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Registered trials

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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.