Evidence map›Paper›PMID 31245011›Full record

ArticleOpen heart

Non-vitamin K antagonist oral anticoagulants in adults with a Fontan circulation: are they safe.

Hayang Yang, Gruschen R Veldtman, Berto J Bouma, Werner Budts, Koichiro Niwa, Folkert Meijboom, Giancarlo Scognamiglio, Alexander Chima Egbe, Markus Schwerzmann, Craig Broberg and 9 more

Open access · goldAbstract read
In one paragraph

Article in Open heart. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 3 pooled it
3.9field-weighted citation impact, top 5% 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

13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 44 citations in OpenAlex.

  1. Pooled it
  2. Safety and Efficacy of DOAC Versus VKA in Adult Congenital Heart Disease: A Systematic Review and Meta-Analysis.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2025
    Pooled it
  3. Systematic Review of Randomized Clinical Trials on Direct Oral Anticoagulants in Pediatric Heart Diseases.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Pooled it
  4. Single Ventricle Fontan: The Basics for General Cardiologists.Methodist DeBakey cardiovascular journal · 2026
    Review
  5. Article
  6. Article
  7. Review
  8. Article
  9. Thromboprophylaxis in Patients With Fontan Circulation.Journal of the American College of Cardiology · 2023
    Article
  10. Article
  11. Thromboembolic complications in adult congenital heart disease: the knowns and the unknowns.Clinical research in cardiology : official journal of the German Cardiac Society · 2021
    Review
  12. Review
  13. 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

19 authors at 17 institutions in 8 countries.

Hayang YangDeparment of Cardiology, AMC, Amsterdam, The Netherlands.ORCID 0000-0002-7150-4068
Gruschen R VeldtmanAdolescent and Adult Congenital Heart Disease Program, Cincinnati Children's Hospital Medical Centre, Cincinnati, Ohio, USA.
Berto J BoumaCardiology, Academical Medical Center-University of Amsterdam, Amsterdam, The Netherlands.
Werner BudtsDepartment of Cardiology, University Hospital Gasthuisberg, Leuven, Belgium.
Koichiro NiwaDeparment of Cardiology, St Luke's International Hospital, Tokyo, Japan.
Folkert MeijboomCardiology, University Medical Centre Utrecht, Utrecht, Netherlands.
Giancarlo ScognamiglioCardiology, Monaldi Hospital-Second University of Naples, Naples, Italy.
Alexander Chima EgbeDeparment of Medicine, Division of Cardiovascular Diseases, Mayo Clinic, Rochester, New York, USA.
Markus SchwerzmannAdult Congenital Heart Diseae Program, University Hospital Inselspital, Bern, Switzerland.ORCID 0000-0002-4006-8929
Craig BrobergKnight Cardiovascular Institute, Oregon Health & Sciences University, Portland, Oregon, USA.
Marielle MorissensDepartment of Cardiology, CHU Brugmann, Brussels, Belgium.
Jonathan BuberHeart Center, Sheba Medical Center, Ramat Gan, Israel.
Shane TsaiDepartment of Cardiology, University of Nebraska Medical Centre, Omaha, Nebraska, USA.
Ioannis PolyzoisAdult Congenital Heart Centre and Centre for Pulmonary Hypertension, Royal Brompton Hospital, London, UK.
Martijn C PostDepartment of Cardiology, St Antonius Hospital, Nieuwegein, The Netherlands.
Matthias GreutmannCardiology, University Hospital Zurich, Zurich, Switzerland.
Arie Van DijkCardiology, Nijmegen University Medical Center, Nijmegen, The Netherlands.
Barbara Jm MulderCardiology, Academic Medical Center, Amsterdam, The Netherlands.
Jamil AboulhosnCardiology, UCLA, Los Angeles, California, USA.
Amsterdam UMC Location University of Amsterdam · NLCentre Hospitalier Universitaire Brugmann · BECincinnati Children's Hospital Medical Center · USMayo Clinic · USOregon Health & Science University · USRadboud University Nijmegen · NLRoyal Brompton Hospital · GBSheba Medical Center · ILSt. Antonius Ziekenhuis · NLSt. Luke's International Hospital · JPUCLA Health · USUniversity Hospital of Bern · CHUniversity Hospital of Zurich · CHUniversity Medical Center Utrecht · NLUniversity of Amsterdam · NLUniversity of Campania "Luigi Vanvitelli" · ITUniversity of Nebraska Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: In Fontan patients with atrial arrhythmias (AA), non-vitamin K antagonist oral anticoagulants(NOACs) have a class III recommendation according to the Pediatric & Congenital Electrophysiology Society (PACES)/Heart Rhythm Society (HRS) guideline in 2014, due to lack of data on outcomes as opposed to evidence of harm. To address this gap in data, we investigated the safety and efficacy of NOACs in adults with a Fontan circulation in a worldwide study. Methods: This is an international multicentre prospective cohort study, using data from the NOTE ( Results: From April 2014 onward, 74 patients (mean age 32±10 years (range 18-68), 54% male) with a Fontan circulation using NOACs were included. During a median follow-up of 1.2 (IQR 0.8-2.0) years, three thromboembolic events (2.9 per 100 patient-years (95% CI 0.7 to 7.6)) and three major bleedings (2.9 per 100 patient-years (95% CI 0.7 to 7.6)) occurred in five atriopulmonary Fontan and one total cavopulmonary connection Fontan patients with AA. Fifteen patients experienced minor bleeding episodes (15.8 per 100 patient-years (95% CI 9.1 to 25.2)). In patients (n=37) using vitamin K antagonists (VKAs) prior to the initiation of NOAC, annual incidence of historical thromboembolic events and major bleeding were 2.4% (95% CI 0.4% to 7.4%) (n = 2) and 1.2% (95% CI 0.7% to 5.1%) (n = 1), respectively. Conclusions: In this review of the largest Fontan cohort using NOACs with prospective follow-up, NOACs appear to be well tolerated and their efficacy and safety during short-term follow-up seem comparable to VKAs. Longer term data are required to confirm these promising short-term results.

Indexed as

adult congenital heart diseaseanticoagulationbleedingfontan circulationthromboembolism

Identifiers

PMID31245011
PMCPMC6560660
OpenAlexW2949029539

What OpenQuestion holds

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LicenceCC BY
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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.