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 Egbe, Markus Schwerzmann, Craig Broberg, Marielle Morissens, Jonathan Buber, Shane Tsai, Ioannis Polyzois, Martijn C. Post, Matthias Greutmann, Arie Van Dijk, Barbara J.M. Mulder, Jamil Aboulhosn

Research output: Contribution to journalArticle

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 (non-Vitamin K antagonist oral anticoagulants for thromboembolic prevention in patients with congenital heart disease) registry. The study population comprised consecutive adults with a Fontan circulation using NOACs. Follow-up took place at 6 months and yearly thereafter. The primary endpoints were thromboembolism and major bleeding. Secondary endpoint was minor bleeding. 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.

Original languageEnglish (US)
Article number000985
JournalOpen Heart
Volume6
Issue number1
DOIs
StatePublished - Jun 1 2019

Fingerprint

Anticoagulants
Hemorrhage
Vitamin K
Cardiac Arrhythmias
Safety
Electrophysiology
Thromboembolism
Registries
Heart Diseases
Cohort Studies
Prospective Studies
Guidelines
Pediatrics
Incidence
Population

Keywords

  • adult congenital heart disease
  • anticoagulation
  • bleeding
  • fontan circulation
  • thromboembolism

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Yang, H., Veldtman, G. R., Bouma, B. J., Budts, W., Niwa, K., Meijboom, F., ... Aboulhosn, J. (2019). Non-Vitamin K antagonist oral anticoagulants in adults with a Fontan circulation: Are they safe. Open Heart, 6(1), [000985]. https://doi.org/10.1136/openhrt-2018-000985

Non-Vitamin K antagonist oral anticoagulants in adults with a Fontan circulation : Are they safe. / Yang, Hayang; Veldtman, Gruschen R.; Bouma, Berto J.; Budts, Werner; Niwa, Koichiro; Meijboom, Folkert; Scognamiglio, Giancarlo; Egbe, Alexander; Schwerzmann, Markus; Broberg, Craig; Morissens, Marielle; Buber, Jonathan; Tsai, Shane; Polyzois, Ioannis; Post, Martijn C.; Greutmann, Matthias; Van Dijk, Arie; Mulder, Barbara J.M.; Aboulhosn, Jamil.

In: Open Heart, Vol. 6, No. 1, 000985, 01.06.2019.

Research output: Contribution to journalArticle

Yang, H, Veldtman, GR, Bouma, BJ, Budts, W, Niwa, K, Meijboom, F, Scognamiglio, G, Egbe, A, Schwerzmann, M, Broberg, C, Morissens, M, Buber, J, Tsai, S, Polyzois, I, Post, MC, Greutmann, M, Van Dijk, A, Mulder, BJM & Aboulhosn, J 2019, 'Non-Vitamin K antagonist oral anticoagulants in adults with a Fontan circulation: Are they safe', Open Heart, vol. 6, no. 1, 000985. https://doi.org/10.1136/openhrt-2018-000985
Yang, Hayang ; Veldtman, Gruschen R. ; Bouma, Berto J. ; Budts, Werner ; Niwa, Koichiro ; Meijboom, Folkert ; Scognamiglio, Giancarlo ; Egbe, Alexander ; Schwerzmann, Markus ; Broberg, Craig ; Morissens, Marielle ; Buber, Jonathan ; Tsai, Shane ; Polyzois, Ioannis ; Post, Martijn C. ; Greutmann, Matthias ; Van Dijk, Arie ; Mulder, Barbara J.M. ; Aboulhosn, Jamil. / Non-Vitamin K antagonist oral anticoagulants in adults with a Fontan circulation : Are they safe. In: Open Heart. 2019 ; Vol. 6, No. 1.
@article{ad265f3171bd432da8ecfb80f033d218,
title = "Non-Vitamin K antagonist oral anticoagulants in adults with a Fontan circulation: Are they safe",
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 (non-Vitamin K antagonist oral anticoagulants for thromboembolic prevention in patients with congenital heart disease) registry. The study population comprised consecutive adults with a Fontan circulation using NOACs. Follow-up took place at 6 months and yearly thereafter. The primary endpoints were thromboembolism and major bleeding. Secondary endpoint was minor bleeding. 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.",
keywords = "adult congenital heart disease, anticoagulation, bleeding, fontan circulation, thromboembolism",
author = "Hayang Yang and Veldtman, {Gruschen R.} and Bouma, {Berto J.} and Werner Budts and Koichiro Niwa and Folkert Meijboom and Giancarlo Scognamiglio and Alexander Egbe and Markus Schwerzmann and Craig Broberg and Marielle Morissens and Jonathan Buber and Shane Tsai and Ioannis Polyzois and Post, {Martijn C.} and Matthias Greutmann and {Van Dijk}, Arie and Mulder, {Barbara J.M.} and Jamil Aboulhosn",
year = "2019",
month = "6",
day = "1",
doi = "10.1136/openhrt-2018-000985",
language = "English (US)",
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T1 - Non-Vitamin K antagonist oral anticoagulants in adults with a Fontan circulation

T2 - Are they safe

AU - Yang, Hayang

AU - Veldtman, Gruschen R.

AU - Bouma, Berto J.

AU - Budts, Werner

AU - Niwa, Koichiro

AU - Meijboom, Folkert

AU - Scognamiglio, Giancarlo

AU - Egbe, Alexander

AU - Schwerzmann, Markus

AU - Broberg, Craig

AU - Morissens, Marielle

AU - Buber, Jonathan

AU - Tsai, Shane

AU - Polyzois, Ioannis

AU - Post, Martijn C.

AU - Greutmann, Matthias

AU - Van Dijk, Arie

AU - Mulder, Barbara J.M.

AU - Aboulhosn, Jamil

PY - 2019/6/1

Y1 - 2019/6/1

N2 - 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 (non-Vitamin K antagonist oral anticoagulants for thromboembolic prevention in patients with congenital heart disease) registry. The study population comprised consecutive adults with a Fontan circulation using NOACs. Follow-up took place at 6 months and yearly thereafter. The primary endpoints were thromboembolism and major bleeding. Secondary endpoint was minor bleeding. 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.

AB - 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 (non-Vitamin K antagonist oral anticoagulants for thromboembolic prevention in patients with congenital heart disease) registry. The study population comprised consecutive adults with a Fontan circulation using NOACs. Follow-up took place at 6 months and yearly thereafter. The primary endpoints were thromboembolism and major bleeding. Secondary endpoint was minor bleeding. 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.

KW - adult congenital heart disease

KW - anticoagulation

KW - bleeding

KW - fontan circulation

KW - thromboembolism

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