Is Initiating NOACs for Atrial Arrhythmias Safe in Adults with Congenital Heart Disease?

On behalf of The Non vitamin K antagonist Oral anticoagulants for ThromboEmbolic prevention in adult congenital heart disease (NOTE) investigators, Hayang Yang, Berto J. Bouma, Barbara J.M. Mulder, J. F. Heidendael, G. Veen, T. C. Konings, G. T.J. Sieswerda, F. J. Meijboom, M. C. Post, A. van Dijk, W. Budts, M. Morissens, M. Ladouceur, D. Tobler, M. Schwerzmann, T. Rutz, J. Bouchardy, M. Greutmann, G. Scognamiglio & 15 others K. Skoglund, C. Christersson, L. Gumbiene, M. Laukyte, P. Khairy, J. Aboulhosn, G. Veldtman, G. Webb, C. S. Broberg, A. R. Opotowsky, K. Shafer, S. F. Tsai, T. Moe, K. Niwa, A. Mizuno

    Research output: Contribution to journalArticle

    Abstract

    Background: In recent years, non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) have been increasingly prescribed to adults with congenital heart disease (CHD) and atrial arrhythmias without good evidence for either safety or efficacy. To address this gap, we initiated an ongoing prospective global registry (NOTE: non-vitamin K antagonist oral anticoagulants for thromboembolic prevention in patients with congenital heart disease). Using the NOTE registry data, the present study aimed to evaluate the occurrence of any adverse events during the initiation phase (first 30 days) of NOACs in adults with CHD and atrial arrhythmias. Methods and Results: For this prospective observational study, 99 adults with CHD and atrial arrhythmias (median age 49 years [IQR 38-61], 53% male) who initiated NOACs at or after the inclusion point were analysed. Thromboembolic events, major bleeding and other minor adverse events were assessed after the first 30 days since the initiation of NOACs. In 54 patients transitioning from VKA to NOACs, 8 minor adverse events (5 minor bleeding; 3 side-effects; 1 drop-out due to minor bleeding) occurred within 30 days after the transition. No adverse events were reported in 46 VKA-naive patients within 30 days after the initiation of NOACs. Conclusions: Initiation of NOACs and transition from VKA to NOACs seem to be safe during the first month, without major adverse events and with only limited minor side effects in adults with CHD and atrial arrhythmias. This global ongoing prospective registry enables precise collection of important clinical information in real-world adults with CHD, managed with NOACs.

    LanguageEnglish (US)
    Pages413-417
    Number of pages5
    JournalCardiovascular Drugs and Therapy
    Volume31
    Issue number4
    DOIs
    StatePublished - Aug 1 2017

    Fingerprint

    Cardiac Arrhythmias
    Heart Diseases
    Vitamin K
    Registries
    Hemorrhage
    Anticoagulants
    N(4)-oleylcytosine arabinoside
    Observational Studies
    Prospective Studies
    Safety

    Keywords

    • Anticoagulation
    • Atrial arrhythmia
    • Bleeding
    • Congenital heart disease
    • Non vitamin K antagonist oral anticoagulant
    • Thromboembolic event

    ASJC Scopus subject areas

    • Pharmacology
    • Cardiology and Cardiovascular Medicine
    • Pharmacology (medical)

    Cite this

    On behalf of The Non vitamin K antagonist Oral anticoagulants for ThromboEmbolic prevention in adult congenital heart disease (NOTE) investigators (2017). Is Initiating NOACs for Atrial Arrhythmias Safe in Adults with Congenital Heart Disease? Cardiovascular Drugs and Therapy, 31(4), 413-417. DOI: 10.1007/s10557-017-6745-y

    Is Initiating NOACs for Atrial Arrhythmias Safe in Adults with Congenital Heart Disease? / On behalf of The Non vitamin K antagonist Oral anticoagulants for ThromboEmbolic prevention in adult congenital heart disease (NOTE) investigators.

    In: Cardiovascular Drugs and Therapy, Vol. 31, No. 4, 01.08.2017, p. 413-417.

    Research output: Contribution to journalArticle

    On behalf of The Non vitamin K antagonist Oral anticoagulants for ThromboEmbolic prevention in adult congenital heart disease (NOTE) investigators 2017, 'Is Initiating NOACs for Atrial Arrhythmias Safe in Adults with Congenital Heart Disease?' Cardiovascular Drugs and Therapy, vol 31, no. 4, pp. 413-417. DOI: 10.1007/s10557-017-6745-y
    On behalf of The Non vitamin K antagonist Oral anticoagulants for ThromboEmbolic prevention in adult congenital heart disease (NOTE) investigators. Is Initiating NOACs for Atrial Arrhythmias Safe in Adults with Congenital Heart Disease? Cardiovascular Drugs and Therapy. 2017 Aug 1;31(4):413-417. Available from, DOI: 10.1007/s10557-017-6745-y
    On behalf of The Non vitamin K antagonist Oral anticoagulants for ThromboEmbolic prevention in adult congenital heart disease (NOTE) investigators. / Is Initiating NOACs for Atrial Arrhythmias Safe in Adults with Congenital Heart Disease?. In: Cardiovascular Drugs and Therapy. 2017 ; Vol. 31, No. 4. pp. 413-417
    @article{ba5ca0164a9546a49247f8d5d15d611b,
    title = "Is Initiating NOACs for Atrial Arrhythmias Safe in Adults with Congenital Heart Disease?",
    abstract = "Background: In recent years, non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) have been increasingly prescribed to adults with congenital heart disease (CHD) and atrial arrhythmias without good evidence for either safety or efficacy. To address this gap, we initiated an ongoing prospective global registry (NOTE: non-vitamin K antagonist oral anticoagulants for thromboembolic prevention in patients with congenital heart disease). Using the NOTE registry data, the present study aimed to evaluate the occurrence of any adverse events during the initiation phase (first 30 days) of NOACs in adults with CHD and atrial arrhythmias. Methods and Results: For this prospective observational study, 99 adults with CHD and atrial arrhythmias (median age 49 years [IQR 38-61], 53\{%} male) who initiated NOACs at or after the inclusion point were analysed. Thromboembolic events, major bleeding and other minor adverse events were assessed after the first 30 days since the initiation of NOACs. In 54 patients transitioning from VKA to NOACs, 8 minor adverse events (5 minor bleeding; 3 side-effects; 1 drop-out due to minor bleeding) occurred within 30 days after the transition. No adverse events were reported in 46 VKA-naive patients within 30 days after the initiation of NOACs. Conclusions: Initiation of NOACs and transition from VKA to NOACs seem to be safe during the first month, without major adverse events and with only limited minor side effects in adults with CHD and atrial arrhythmias. This global ongoing prospective registry enables precise collection of important clinical information in real-world adults with CHD, managed with NOACs.",
    keywords = "Anticoagulation, Atrial arrhythmia, Bleeding, Congenital heart disease, Non vitamin K antagonist oral anticoagulant, Thromboembolic event",
    author = "{On behalf of The Non vitamin K antagonist Oral anticoagulants for ThromboEmbolic prevention in adult congenital heart disease (NOTE) investigators} and Hayang Yang and Bouma, {Berto J.} and Mulder, {Barbara J.M.} and Heidendael, {J. F.} and G. Veen and Konings, {T. C.} and Sieswerda, {G. T.J.} and Meijboom, {F. J.} and Post, {M. C.} and {van Dijk}, A. and W. Budts and M. Morissens and M. Ladouceur and D. Tobler and M. Schwerzmann and T. Rutz and J. Bouchardy and M. Greutmann and G. Scognamiglio and K. Skoglund and C. Christersson and L. Gumbiene and M. Laukyte and P. Khairy and J. Aboulhosn and G. Veldtman and G. Webb and Broberg, {C. S.} and Opotowsky, {A. R.} and K. Shafer and Tsai, {S. F.} and T. Moe and K. Niwa and A. Mizuno",
    year = "2017",
    month = "8",
    day = "1",
    doi = "10.1007/s10557-017-6745-y",
    language = "English (US)",
    volume = "31",
    pages = "413--417",
    journal = "Cardiovascular Drugs and Therapy",
    issn = "0920-3206",
    publisher = "Kluwer Academic Publishers",
    number = "4",

    }

    TY - JOUR

    T1 - Is Initiating NOACs for Atrial Arrhythmias Safe in Adults with Congenital Heart Disease?

    AU - On behalf of The Non vitamin K antagonist Oral anticoagulants for ThromboEmbolic prevention in adult congenital heart disease (NOTE) investigators

    AU - Yang,Hayang

    AU - Bouma,Berto J.

    AU - Mulder,Barbara J.M.

    AU - Heidendael,J. F.

    AU - Veen,G.

    AU - Konings,T. C.

    AU - Sieswerda,G. T.J.

    AU - Meijboom,F. J.

    AU - Post,M. C.

    AU - van Dijk,A.

    AU - Budts,W.

    AU - Morissens,M.

    AU - Ladouceur,M.

    AU - Tobler,D.

    AU - Schwerzmann,M.

    AU - Rutz,T.

    AU - Bouchardy,J.

    AU - Greutmann,M.

    AU - Scognamiglio,G.

    AU - Skoglund,K.

    AU - Christersson,C.

    AU - Gumbiene,L.

    AU - Laukyte,M.

    AU - Khairy,P.

    AU - Aboulhosn,J.

    AU - Veldtman,G.

    AU - Webb,G.

    AU - Broberg,C. S.

    AU - Opotowsky,A. R.

    AU - Shafer,K.

    AU - Tsai,S. F.

    AU - Moe,T.

    AU - Niwa,K.

    AU - Mizuno,A.

    PY - 2017/8/1

    Y1 - 2017/8/1

    N2 - Background: In recent years, non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) have been increasingly prescribed to adults with congenital heart disease (CHD) and atrial arrhythmias without good evidence for either safety or efficacy. To address this gap, we initiated an ongoing prospective global registry (NOTE: non-vitamin K antagonist oral anticoagulants for thromboembolic prevention in patients with congenital heart disease). Using the NOTE registry data, the present study aimed to evaluate the occurrence of any adverse events during the initiation phase (first 30 days) of NOACs in adults with CHD and atrial arrhythmias. Methods and Results: For this prospective observational study, 99 adults with CHD and atrial arrhythmias (median age 49 years [IQR 38-61], 53% male) who initiated NOACs at or after the inclusion point were analysed. Thromboembolic events, major bleeding and other minor adverse events were assessed after the first 30 days since the initiation of NOACs. In 54 patients transitioning from VKA to NOACs, 8 minor adverse events (5 minor bleeding; 3 side-effects; 1 drop-out due to minor bleeding) occurred within 30 days after the transition. No adverse events were reported in 46 VKA-naive patients within 30 days after the initiation of NOACs. Conclusions: Initiation of NOACs and transition from VKA to NOACs seem to be safe during the first month, without major adverse events and with only limited minor side effects in adults with CHD and atrial arrhythmias. This global ongoing prospective registry enables precise collection of important clinical information in real-world adults with CHD, managed with NOACs.

    AB - Background: In recent years, non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) have been increasingly prescribed to adults with congenital heart disease (CHD) and atrial arrhythmias without good evidence for either safety or efficacy. To address this gap, we initiated an ongoing prospective global registry (NOTE: non-vitamin K antagonist oral anticoagulants for thromboembolic prevention in patients with congenital heart disease). Using the NOTE registry data, the present study aimed to evaluate the occurrence of any adverse events during the initiation phase (first 30 days) of NOACs in adults with CHD and atrial arrhythmias. Methods and Results: For this prospective observational study, 99 adults with CHD and atrial arrhythmias (median age 49 years [IQR 38-61], 53% male) who initiated NOACs at or after the inclusion point were analysed. Thromboembolic events, major bleeding and other minor adverse events were assessed after the first 30 days since the initiation of NOACs. In 54 patients transitioning from VKA to NOACs, 8 minor adverse events (5 minor bleeding; 3 side-effects; 1 drop-out due to minor bleeding) occurred within 30 days after the transition. No adverse events were reported in 46 VKA-naive patients within 30 days after the initiation of NOACs. Conclusions: Initiation of NOACs and transition from VKA to NOACs seem to be safe during the first month, without major adverse events and with only limited minor side effects in adults with CHD and atrial arrhythmias. This global ongoing prospective registry enables precise collection of important clinical information in real-world adults with CHD, managed with NOACs.

    KW - Anticoagulation

    KW - Atrial arrhythmia

    KW - Bleeding

    KW - Congenital heart disease

    KW - Non vitamin K antagonist oral anticoagulant

    KW - Thromboembolic event

    UR - http://www.scopus.com/inward/record.url?scp=85026912492&partnerID=8YFLogxK

    UR - http://www.scopus.com/inward/citedby.url?scp=85026912492&partnerID=8YFLogxK

    U2 - 10.1007/s10557-017-6745-y

    DO - 10.1007/s10557-017-6745-y

    M3 - Article

    VL - 31

    SP - 413

    EP - 417

    JO - Cardiovascular Drugs and Therapy

    T2 - Cardiovascular Drugs and Therapy

    JF - Cardiovascular Drugs and Therapy

    SN - 0920-3206

    IS - 4

    ER -