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

Autor: Gertjan T. Sieswerda, Gruschen R. Veldtman, Barbara J.M. Mulder, Rafael Alonso-Gonzalez, Daniel Tobler, Magdalena Lipczyńska, Lina Gumbiene, Tobias Rutz, Martijn C. Post, Giancarlo Scognamiglio, Magalie Ladouceur, B.J. Bouma, Konstantinos Dimopoulos, Folkert J. Meijboom, Werner Budts, Matthias Greutmann, Jonathan Buber, Jamil Aboulhosn, H. Yang, Marielle Morissens, M. Laukyte, Gary Webb, S. F. Tsai, T.C. Konings, Alexander C. Egbe, Tabitha G. Moe, Judith Bouchardy, Craig S. Broberg, W. Davidson, Paul Khairy, Koichiro Niwa, Kristofer Skoglund, C. Christersson, Keri M. Shafer, Alexander R. Opotowsky, Atsushi Mizuno, Markus Schwerzmann, A.P.J. van Dijk, T. Kronvall, S. Chakrabarti
Přispěvatelé: Cardiology, ACS - Heart failure & arrhythmias, ACS - Pulmonary hypertension & thrombosis, APH - Personalized Medicine, APH - Aging & Later Life
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Male
Cardiac & Cardiovascular Systems
Heart disease
Cardiologie et circulation
Vascular damage Radboud Institute for Health Sciences [Radboudumc 16]
Heart Valve Diseases
030204 cardiovascular system & hematology
Global Health
THERAPY
chemistry.chemical_compound
0302 clinical medicine
PROPOSAL
Quality of life
Edoxaban
Adult congenital heart disease
Prospective Studies
Registries
030212 general & internal medicine
610 Medicine & health
Prospective cohort study
Vitamin K antagonist
Female
Apixaban
Cardiology and Cardiovascular Medicine
Life Sciences & Biomedicine
medicine.drug
Heart Defects
Congenital

medicine.medical_specialty
Adolescent
medicine.drug_class
Hemorrhage
WARFARIN
Dabigatran
Prosthesis Implantation
EVENTS
03 medical and health sciences
Anticoagulation
All institutes and research themes of the Radboud University Medical Center
ADHERENCE
Internal medicine
Thromboembolism
Journal Article
medicine
Humans
NOACs
Bleeding
Valvular disease
Bioprosthesis
Rivaroxaban
ARRHYTHMIAS
Science & Technology
business.industry
ADULTS
medicine.disease
FACTOR ABNORMALITIES
THROMBOSIS
chemistry
ATRIAL-FIBRILLATION
Quality of Life
Cardiovascular System & Cardiology
business
Factor Xa Inhibitors
Zdroj: International journal of cardiology, Shannon : Elsevier Ireland Ltd, 2020, vol. 299, p. 123-130
International journal of cardiology
Yang, H; Bouma, B J; Dimopoulos, K; Khairy, P; Ladouceur, M; Niwa, K; Greutmann, M; Schwerzmann, Markus; 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; ... (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, 299, pp. 123-130. Elsevier 10.1016/j.ijcard.2019.06.014
International Journal of Cardiology, 299, pp. 123-130
International journal of cardiology, 299, 123-130. Elsevier Ireland Ltd
International Journal of Cardiology, 299, 123-130. Elsevier Ireland Ltd
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 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, pp. 123-130 . https://doi.org/10.1016/j.ijcard.2019.06.014
International Journal of Cardiology, 299, 123-130
International Journal of Cardiology, 299, 123. Elsevier Ireland Ltd
ISSN: 0167-5273
1874-1754
DOI: 10.1016/j.ijcard.2019.06.014
Popis: 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.
SCOPUS: ar.j
info:eu-repo/semantics/published
Databáze: OpenAIRE