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

Research output: Contribution to journalArticle

12 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)413-417
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. https://doi.org/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. https://doi.org/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. https://doi.org/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.
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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.",
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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

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