Non-vitamin K antagonist oral anticoagulants (NOACs) for thromboembolic prevention, are they safe in congenital heart disease? Results of a worldwide study

H. Yang, B. J. Bouma, K. Dimopoulos, P. Khairy, M. Ladouceur, K. Niwa, M. Greutmann, M. Schwerzmann, A. Egbe, G. Scognamiglio, W. Budts, G. Veldtman, A. R. Opotowsky, C. S. Broberg, L. Gumbiene, F. J. Meijboom, T. Rutz, M. C. Post, T. Moe, M. Lipczyńska & 20 others S. F. Tsai, S. Chakrabarti, D. Tobler, W. Davidson, M. Morissens, A. van Dijk, J. Buber, J. Bouchardy, K. Skoglund, C. Christersson, T. Kronvall, T. C. Konings, R. Alonso-Gonzalez, A. Mizuno, G. Webb, M. Laukyte, G. T. J. Sieswerda, K. Shafer, J. Aboulhosn, B. J. M. Mulder

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Background: Current guidelines consider vitamin K antagonists (VKA) the oral anticoagulant agents of choice in adults with atrial arrhythmias (AA) and moderate or complex forms of congenital heart disease, significant valvular lesions, or bioprosthetic valves, pending safety data on non-VKA oral anticoagulants (NOACs). Therefore, the international NOTE registry was initiated to assess safety, change in adherence and quality of life (QoL) associated with NOACs in adults with congenital heart disease (ACHD). Methods: An international multicenter prospective study of NOACs in ACHD was established. Follow-up occurred at 6 months and yearly thereafter. Primary endpoints were thromboembolism and major bleeding. Secondary endpoints included minor bleeding, change in therapy adherence (≥80% medication refill rate, ≥6 out of 8 on Morisky-8 questionnaire) and QoL (SF-36 questionnaire). Results: In total, 530 ACHD patients (mean age 47 SD 15 years; 55% male) with predominantly moderate or complex defects (85%), significant valvular lesions (46%) and/or bioprosthetic valves (11%) using NOACs (rivaroxaban 43%; apixaban 39%; dabigatran 12%; edoxaban 7%) were enrolled. The most common indication was AA (91%). Over a median follow-up of 1.0 [IQR 0.0–2.0] year, thromboembolic event rate was 1.0% [95%CI 0.4–2.0] (n = 6) per year, with 1.1% [95%CI 0.5–2.2] (n = 7) annualized rate of major bleeding and 6.3% [95%CI 4.5–8.5] (n = 37) annualized rate of minor bleeding. Adherence was sufficient during 2 years follow-up in 80–93% of patients. At 1-year follow-up, among the subset of previous VKA-users who completed the survey (n = 33), QoL improved in 6 out of 8 domains (p ≪ 0.05). Conclusions: Initial results from our worldwide prospective study suggest that NOACs are safe and may be effective for thromboembolic prevention in adults with heterogeneous forms of congenital heart disease.
Original languageEnglish
JournalInternational Journal of Cardiology
Volume299
DOIs
Publication statusPublished - 15 Jan 2020

Cite this

Yang, H. ; Bouma, B. J. ; Dimopoulos, K. ; Khairy, P. ; Ladouceur, M. ; Niwa, K. ; Greutmann, M. ; Schwerzmann, M. ; Egbe, A. ; Scognamiglio, G. ; Budts, W. ; Veldtman, G. ; Opotowsky, A. R. ; Broberg, C. S. ; Gumbiene, L. ; Meijboom, F. J. ; Rutz, T. ; Post, M. C. ; Moe, T. ; Lipczyńska, M. ; Tsai, S. F. ; Chakrabarti, S. ; Tobler, D. ; Davidson, W. ; Morissens, M. ; van Dijk, A. ; Buber, J. ; Bouchardy, J. ; Skoglund, K. ; Christersson, C. ; Kronvall, T. ; Konings, T. C. ; Alonso-Gonzalez, R. ; Mizuno, A. ; Webb, G. ; Laukyte, M. ; Sieswerda, G. T. J. ; Shafer, K. ; Aboulhosn, J. ; Mulder, B. J. M. / Non-vitamin K antagonist oral anticoagulants (NOACs) for thromboembolic prevention, are they safe in congenital heart disease? Results of a worldwide study. In: International Journal of Cardiology. 2020 ; Vol. 299.
@article{a60e69e0d14c49e291b6f23d2eda9867,
title = "Non-vitamin K antagonist oral anticoagulants (NOACs) for thromboembolic prevention, are they safe in congenital heart disease? Results of a worldwide study",
abstract = "Background: Current guidelines consider vitamin K antagonists (VKA) the oral anticoagulant agents of choice in adults with atrial arrhythmias (AA) and moderate or complex forms of congenital heart disease, significant valvular lesions, or bioprosthetic valves, pending safety data on non-VKA oral anticoagulants (NOACs). Therefore, the international NOTE registry was initiated to assess safety, change in adherence and quality of life (QoL) associated with NOACs in adults with congenital heart disease (ACHD). Methods: An international multicenter prospective study of NOACs in ACHD was established. Follow-up occurred at 6 months and yearly thereafter. Primary endpoints were thromboembolism and major bleeding. Secondary endpoints included minor bleeding, change in therapy adherence (≥80{\%} medication refill rate, ≥6 out of 8 on Morisky-8 questionnaire) and QoL (SF-36 questionnaire). Results: In total, 530 ACHD patients (mean age 47 SD 15 years; 55{\%} male) with predominantly moderate or complex defects (85{\%}), significant valvular lesions (46{\%}) and/or bioprosthetic valves (11{\%}) using NOACs (rivaroxaban 43{\%}; apixaban 39{\%}; dabigatran 12{\%}; edoxaban 7{\%}) were enrolled. The most common indication was AA (91{\%}). Over a median follow-up of 1.0 [IQR 0.0–2.0] year, thromboembolic event rate was 1.0{\%} [95{\%}CI 0.4–2.0] (n = 6) per year, with 1.1{\%} [95{\%}CI 0.5–2.2] (n = 7) annualized rate of major bleeding and 6.3{\%} [95{\%}CI 4.5–8.5] (n = 37) annualized rate of minor bleeding. Adherence was sufficient during 2 years follow-up in 80–93{\%} of patients. At 1-year follow-up, among the subset of previous VKA-users who completed the survey (n = 33), QoL improved in 6 out of 8 domains (p ≪ 0.05). Conclusions: Initial results from our worldwide prospective study suggest that NOACs are safe and may be effective for thromboembolic prevention in adults with heterogeneous forms of congenital heart disease.",
keywords = "Adult congenital heart disease, Anticoagulation, Bleeding, NOACs, Thromboembolism, Valvular disease",
author = "H. Yang and Bouma, {B. J.} and K. Dimopoulos and P. Khairy and M. Ladouceur and K. Niwa and M. Greutmann and M. Schwerzmann and A. Egbe and G. Scognamiglio and W. Budts and G. Veldtman and Opotowsky, {A. R.} and Broberg, {C. S.} and L. Gumbiene and Meijboom, {F. J.} and T. Rutz and Post, {M. C.} and T. Moe and M. Lipczyńska and Tsai, {S. F.} and S. Chakrabarti and D. Tobler and W. Davidson and M. Morissens and {van Dijk}, A. and J. Buber and J. Bouchardy and K. Skoglund and C. Christersson and T. Kronvall and Konings, {T. C.} and R. Alonso-Gonzalez and A. Mizuno and G. Webb and M. Laukyte and Sieswerda, {G. T. J.} and K. Shafer and J. Aboulhosn and Mulder, {B. J. M.}",
year = "2020",
month = "1",
day = "15",
doi = "10.1016/j.ijcard.2019.06.014",
language = "English",
volume = "299",
journal = "International Journal of Cardiology",
issn = "0167-5273",
publisher = "Elsevier Ireland Ltd",

}

Yang, H, Bouma, BJ, Dimopoulos, K, Khairy, P, Ladouceur, M, Niwa, K, Greutmann, M, Schwerzmann, M, Egbe, A, Scognamiglio, G, Budts, W, Veldtman, G, Opotowsky, AR, Broberg, CS, Gumbiene, L, Meijboom, FJ, Rutz, T, Post, MC, Moe, T, Lipczyńska, M, Tsai, SF, Chakrabarti, S, Tobler, D, Davidson, W, Morissens, M, van Dijk, A, Buber, J, Bouchardy, J, Skoglund, K, Christersson, C, Kronvall, T, Konings, TC, Alonso-Gonzalez, R, Mizuno, A, Webb, G, Laukyte, M, Sieswerda, GTJ, Shafer, K, Aboulhosn, J & Mulder, BJM 2020, 'Non-vitamin K antagonist oral anticoagulants (NOACs) for thromboembolic prevention, are they safe in congenital heart disease? Results of a worldwide study' International Journal of Cardiology, vol. 299. https://doi.org/10.1016/j.ijcard.2019.06.014

Non-vitamin K antagonist oral anticoagulants (NOACs) for thromboembolic prevention, are they safe in congenital heart disease? Results of a worldwide study. / Yang, H.; Bouma, B. J.; Dimopoulos, K.; Khairy, P.; Ladouceur, M.; Niwa, K.; Greutmann, M.; Schwerzmann, M.; Egbe, A.; Scognamiglio, G.; Budts, W.; Veldtman, G.; Opotowsky, A. R.; Broberg, C. S.; Gumbiene, L.; Meijboom, F. J.; Rutz, T.; Post, M. C.; Moe, T.; Lipczyńska, M.; Tsai, S. F.; Chakrabarti, S.; Tobler, D.; Davidson, W.; Morissens, M.; van Dijk, A.; Buber, J.; Bouchardy, J.; Skoglund, K.; Christersson, C.; Kronvall, T.; Konings, T. C.; Alonso-Gonzalez, R.; Mizuno, A.; Webb, G.; Laukyte, M.; Sieswerda, G. T. J.; Shafer, K.; Aboulhosn, J.; Mulder, B. J. M.

In: International Journal of Cardiology, Vol. 299, 15.01.2020.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Non-vitamin K antagonist oral anticoagulants (NOACs) for thromboembolic prevention, are they safe in congenital heart disease? Results of a worldwide study

AU - Yang, H.

AU - Bouma, B. J.

AU - Dimopoulos, K.

AU - Khairy, P.

AU - Ladouceur, M.

AU - Niwa, K.

AU - Greutmann, M.

AU - Schwerzmann, M.

AU - Egbe, A.

AU - Scognamiglio, G.

AU - Budts, W.

AU - Veldtman, G.

AU - Opotowsky, A. R.

AU - Broberg, C. S.

AU - Gumbiene, L.

AU - Meijboom, F. J.

AU - Rutz, T.

AU - Post, M. C.

AU - Moe, T.

AU - Lipczyńska, M.

AU - Tsai, S. F.

AU - Chakrabarti, S.

AU - Tobler, D.

AU - Davidson, W.

AU - Morissens, M.

AU - van Dijk, A.

AU - Buber, J.

AU - Bouchardy, J.

AU - Skoglund, K.

AU - Christersson, C.

AU - Kronvall, T.

AU - Konings, T. C.

AU - Alonso-Gonzalez, R.

AU - Mizuno, A.

AU - Webb, G.

AU - Laukyte, M.

AU - Sieswerda, G. T. J.

AU - Shafer, K.

AU - Aboulhosn, J.

AU - Mulder, B. J. M.

PY - 2020/1/15

Y1 - 2020/1/15

N2 - Background: Current guidelines consider vitamin K antagonists (VKA) the oral anticoagulant agents of choice in adults with atrial arrhythmias (AA) and moderate or complex forms of congenital heart disease, significant valvular lesions, or bioprosthetic valves, pending safety data on non-VKA oral anticoagulants (NOACs). Therefore, the international NOTE registry was initiated to assess safety, change in adherence and quality of life (QoL) associated with NOACs in adults with congenital heart disease (ACHD). Methods: An international multicenter prospective study of NOACs in ACHD was established. Follow-up occurred at 6 months and yearly thereafter. Primary endpoints were thromboembolism and major bleeding. Secondary endpoints included minor bleeding, change in therapy adherence (≥80% medication refill rate, ≥6 out of 8 on Morisky-8 questionnaire) and QoL (SF-36 questionnaire). Results: In total, 530 ACHD patients (mean age 47 SD 15 years; 55% male) with predominantly moderate or complex defects (85%), significant valvular lesions (46%) and/or bioprosthetic valves (11%) using NOACs (rivaroxaban 43%; apixaban 39%; dabigatran 12%; edoxaban 7%) were enrolled. The most common indication was AA (91%). Over a median follow-up of 1.0 [IQR 0.0–2.0] year, thromboembolic event rate was 1.0% [95%CI 0.4–2.0] (n = 6) per year, with 1.1% [95%CI 0.5–2.2] (n = 7) annualized rate of major bleeding and 6.3% [95%CI 4.5–8.5] (n = 37) annualized rate of minor bleeding. Adherence was sufficient during 2 years follow-up in 80–93% of patients. At 1-year follow-up, among the subset of previous VKA-users who completed the survey (n = 33), QoL improved in 6 out of 8 domains (p ≪ 0.05). Conclusions: Initial results from our worldwide prospective study suggest that NOACs are safe and may be effective for thromboembolic prevention in adults with heterogeneous forms of congenital heart disease.

AB - Background: Current guidelines consider vitamin K antagonists (VKA) the oral anticoagulant agents of choice in adults with atrial arrhythmias (AA) and moderate or complex forms of congenital heart disease, significant valvular lesions, or bioprosthetic valves, pending safety data on non-VKA oral anticoagulants (NOACs). Therefore, the international NOTE registry was initiated to assess safety, change in adherence and quality of life (QoL) associated with NOACs in adults with congenital heart disease (ACHD). Methods: An international multicenter prospective study of NOACs in ACHD was established. Follow-up occurred at 6 months and yearly thereafter. Primary endpoints were thromboembolism and major bleeding. Secondary endpoints included minor bleeding, change in therapy adherence (≥80% medication refill rate, ≥6 out of 8 on Morisky-8 questionnaire) and QoL (SF-36 questionnaire). Results: In total, 530 ACHD patients (mean age 47 SD 15 years; 55% male) with predominantly moderate or complex defects (85%), significant valvular lesions (46%) and/or bioprosthetic valves (11%) using NOACs (rivaroxaban 43%; apixaban 39%; dabigatran 12%; edoxaban 7%) were enrolled. The most common indication was AA (91%). Over a median follow-up of 1.0 [IQR 0.0–2.0] year, thromboembolic event rate was 1.0% [95%CI 0.4–2.0] (n = 6) per year, with 1.1% [95%CI 0.5–2.2] (n = 7) annualized rate of major bleeding and 6.3% [95%CI 4.5–8.5] (n = 37) annualized rate of minor bleeding. Adherence was sufficient during 2 years follow-up in 80–93% of patients. At 1-year follow-up, among the subset of previous VKA-users who completed the survey (n = 33), QoL improved in 6 out of 8 domains (p ≪ 0.05). Conclusions: Initial results from our worldwide prospective study suggest that NOACs are safe and may be effective for thromboembolic prevention in adults with heterogeneous forms of congenital heart disease.

KW - Adult congenital heart disease

KW - Anticoagulation

KW - Bleeding

KW - NOACs

KW - Thromboembolism

KW - Valvular disease

UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85068777903&origin=inward

UR - https://www.ncbi.nlm.nih.gov/pubmed/31307847

U2 - 10.1016/j.ijcard.2019.06.014

DO - 10.1016/j.ijcard.2019.06.014

M3 - Article

VL - 299

JO - International Journal of Cardiology

JF - International Journal of Cardiology

SN - 0167-5273

ER -