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, 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 Chima; 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, AC, 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 Chima ; 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.
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    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 Egbe, {Alexander Chima} 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",
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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 Chima

    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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