Is Initiating NOACs for Atrial Arrhythmias Safe in Adults with Congenital Heart Disease?
Yang, Hayang; Bouma, Berto J.; Mulder, Barbara J M; Heidendael, J. F.; Veen, G.; Konings, Thelma C; Sieswerda, G. T.J.; Meijboom, F. J.; Post, M. C.; van Dijk, A.; Budts, W.; Morissens, M.; Ladouceur-Wodzak, Michelle; Tobler, D.; Schwerzmann, M.; Rutz, T.; Bouchardy, J.; Greutmann, M.; Scognamiglio, G.; Skoglund, K.; Christersson, C.; Gumbiene, L.; Laukyte, M.; Khairy, P.; Aboulhosn, J.; Veldtman, G.; Webb, G.; Broberg, C. S.; Opotowsky, A. R.; Shafer, K.; Tsai, S. F.; Moe, T.; Niwa, K.; Mizuno, A.; On behalf of The Non vitamin K antagonist Oral anticoagulants for ThromboEmbolic prevention in adult congenital heart disease (NOTE) investigators
(2017) Cardiovascular Drugs and Therapy, volume 31, issue 4, pp. 413 - 417
(Article)
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
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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.
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Keywords: Anticoagulation, Atrial arrhythmia, Bleeding, Congenital heart disease, Non vitamin K antagonist oral anticoagulant, Thromboembolic event, Pharmacology, Cardiology and Cardiovascular Medicine, Pharmacology (medical)
ISSN: 0920-3206
Publisher: Kluwer Academic Publishers
Note: Funding Information: Funding 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, 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: Conflict of Interest 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. Dr. B.J.M. Mulder has received restricted research grants from Ingelheim-Boehringer, Bayer, and Daiichi Sankyo. Authors, 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, Tobler, M. Schwerzmann, T. Rutz, J. Bouchardy, M. Greutmann, G. Scognamiglio, K. Skoglund, C. Christersson, L. Gumbiene, M. Laukyte, P. Khairy, J. Aboulhosn, G. Veldtman, G. Webb, C.S. Broberg, A.R. Opotowsky, MD, K. Shafer, S.F. Tsai, T. Moe, K. Niwa, A. Mizuno declare that they have no conflict of interest. Publisher Copyright: © 2017, The Author(s).
(Peer reviewed)