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.
(2020) International Journal of Cardiology, volume 299, pp. 123 - 130
(Article)
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
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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.
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Keywords: Adult congenital heart disease, Anticoagulation, Bleeding, NOACs, Thromboembolism, Valvular disease, Cardiology and Cardiovascular Medicine, Journal Article
ISSN: 0167-5273
Publisher: Elsevier Ireland Ltd
Note: Funding Information: Dr. C. Christersson has received speaker fees from Bristol Myers Squibb, CSL Behring and Novartis, and advisory board fees from Boehringer Ingelheim. Dr. B.J. Bouma has received restricted research grant from Bristol-Myers Squibb and Pfizer. Dr. B.J.M. Mulder has received restricted research grants from Ingelheim-Boehringer, Bayer, and Daiichi Sankyo. Dr. Chakrabarti received educational grant from Industry – Server, Canada to fund research processes and data collection. Funding Information: The work described in this study was carried out in the context of the Parelsnoer Institute (PSI). PSI is part of and funded by the Dutch Federation of University Medical Centres . This work is supported by restricted research grants from Bristol-Myers Squibb , Pfizer , Ingelheim-Boehringer , Bayer , and Daiichi Sankyo . These companies had no role in data collection, analysis, or interpretation, or in the decision to submit this article for publication. Funding Information: The work described in this study was carried out in the context of the Parelsnoer Institute (PSI). PSI is part of and funded by the Dutch Federation of University Medical Centres. This work is supported by restricted research grants from Bristol-Myers Squibb, Pfizer, Ingelheim-Boehringer, Bayer, and Daiichi Sankyo. These companies had no role in data collection, analysis, or interpretation, or in the decision to submit this article for publication. Publisher Copyright: © 2019 The Authors
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