Evidence map›Paper›PMID 35450838›Full record

Trial reportEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2022

Bleeding risk differences after TAVR according to the ARC-HBR criteria: insights from SCOPE 2.

Philippe Garot, Antoinette Neylon, Marie-Claude Morice, Corrado Tamburino, Sabine Bleiziffer, Holger Thiele, Smita Scholtz, Rene Schramm, James Cockburn, Michael Cunnington and 12 more

Abstract readRandomized 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, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

11 citing papers in PubMed.

  1. Observational
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. Review
  8. Review
  9. Defining high bleeding risk in patients undergoing transcatheter aortic valve implantation: a VARC-HBR consensus document.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024
    Article
  10. Comparison of different percutaneous revascularisation timing strategies in patients undergoing transcatheter aortic valve implantation.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2023
    Article
  11. ARC-HBR criteria and TAVR: not all high bleeding risk patients look alike.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2022
    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

22 authors.

Philippe GarotInstitut Cardiovasculaire Paris-Sud, Hôpital Privé Jacques Cartier, Ramsay-Santé, Massy, France.
Antoinette NeylonInstitut Cardiovasculaire Paris-Sud, Hôpital Privé Jacques Cartier, Ramsay-Santé, Massy, France.
Marie-Claude MoriceInstitut Cardiovasculaire Paris-Sud, Hôpital Privé Jacques Cartier, Ramsay-Santé, Massy, France.
Corrado TamburinoDivision of Cardiology Azienda Ospedaliero Universitaria "Policlinico-Vittorio Emanuele" University of Catania, Catania, Italy.
Sabine BleizifferDepartment of Thoracic and Cardiovascular Surgery, Heart and Diabetes Center Northrhein-Westfalia, University Hospital, Ruhr-University Bochum, Bad Oeynhausen, Germany.
Holger ThieleDepartment of Cardiology, Leipzig Heart Center, University of Leipzig, Leipzig, Germany.
Smita ScholtzDepartment of Interventional Cardiology, Heart and Diabetes Center North Rhine Westfalia, Bad Oeynhausen, Germany.
Rene SchrammDepartment of Thoracic and Cardiovascular Surgery, Heart and Diabetes Center Northrhein-Westfalia, University Hospital, Ruhr-University Bochum, Bad Oeynhausen, Germany.
James CockburnDepartment of Cardiology, Brighton & Sussex University Hospitals NHS Trust, Brighton, United Kingdom.
Michael CunningtonDepartment of Cardiology, Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom.
Alexander WolfDepartment of Interventional Cardiology, Elisabeth Hospital Essen, Essen, Germany.
Marco BarbantiDepartment of Cardio-Thoracic-Vascular diseases and transplantation, Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico-San Marco", Catania, Italy.
Didier TchetchéGroupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France.
Paolo PagnottaDepartment of Cardiovascular Medicine, Humanitas Clinical and Research Center, Milano, Italy.
Martine GilardDepartment of Cardiology, Brest University Hospital, Brest, France.
Francesco BedogniCardiology Department, IRCCS Policlinico San Donato, Milano, Italy.
Eric Van BelleDepartment of Cardiology, Lille University Hospital, Lille, France.
Mariuca Vasa-NicoteraDepartment of Cardiology, Goethe University Hospital Frankfurt, Frankfurt am Main, Germany.
Alaide ChieffoInterventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Kris BogaertsKU Leuven, Faculty of Medicine, I-BioStat, Leuven, Belgium and UHasselt, I-BioStat, Hasselt, Belgium.
Christian HengstenbergDepartment of Internal Medicine II, Medical University of Vienna, Vienna, Austria.
Davide CapodannoDivision of Cardiology Azienda Ospedaliero Universitaria "Policlinico-Vittorio Emanuele" University of Catania, Catania, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe Academic Research Consortium - High Bleeding Risk (ARC-HBR) initiative defined conditions associated with percutaneous coronary intervention (PCI)-related bleeding.

aimsWe sought to further explore these HBR conditions in the setting of transcatheter aortic valve replacement (TAVR).

methodsPatients from the SCOPE 2 trial were stratified by their bleeding risk status based on the ARC-HBR definitions. Baseline and procedural characteristics, as well as key clinical outcomes including Bleeding Academic Research Consortium (BARC) 3-5 bleeding, were compared in ARC-HBR positive (HBR+) and ARC-HBR negative (HBR-) patients.

resultsOf 787 patients randomised in SCOPE 2 and included in this study, 633 were HBR+ (80.4%). Compared with HBR- patients, those HBR+ were older and more frequently presented with diabetes, a history of coronary artery disease, atrial fibrillation, prior cerebrovascular accident, and a Society of Thoracic Surgeons predicted risk of 30-day mortality (STS-PROM) (4.9±2.9% vs 3.3%±2.1%; p<0.0001). In addition, HBR+ patients were more frequently on oral anticoagulation therapy. At 1 year, HBR+ patients had higher rates of all-cause death (12.4% vs 4.3%, respectively, risk difference 8.09%; 95% confidence interval [CI]: 3.76-12.41; p=0.0002); the rates of BARC 3-5 type bleeding were relatively high but not statistically different compared with HBR- patients (7.7% vs 6.1%, risk difference 1.67%; 95% CI: -2.72 to 6.06; p=0.46). Subgroup analyses for bleeding events showed no significant interaction in terms of STS-PROM score, age, or medications.

conclusionsThe ARC-HBR criteria failed to isolate a subgroup of patients at higher bleeding risk in TAVR patients from a randomised trial. These findings have potential implications, especially for the selection of post-TAVR antithrombotic regimens based on individual bleeding-risk profiles. Specific HBR criteria should be defined for TAVR patients.

Indexed as

Percutaneous Coronary InterventionTranscatheter Aortic Valve ReplacementHemorrhageHumansPlatelet Aggregation InhibitorsRisk AssessmentRisk FactorsTreatment OutcomePlatelet Aggregation Inhibitors

Identifiers

PMID35450838
PMCPMC10241269

What OpenQuestion holds

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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.