Non-vitamin K antagonist oral anticoagulants in adults with a Fontan circulation: are they safe.
- Yang H Deparment of Cardiology, AMC, Amsterdam, The Netherlands.
- Veldtman GR Adolescent and Adult Congenital Heart Disease Program, Cincinnati Children's Hospital Medical Centre, Cincinnati, Ohio, USA.
- Bouma BJ Cardiology, Academical Medical Center-University of Amsterdam, Amsterdam, The Netherlands.
- Budts W Department of Cardiology, University Hospital Gasthuisberg, Leuven, Belgium.
- Niwa K Deparment of Cardiology, St Luke's International Hospital, Tokyo, Japan.
- Meijboom F Cardiology, University Medical Centre Utrecht, Utrecht, Netherlands.
- Scognamiglio G Cardiology, Monaldi Hospital-Second University of Naples, Naples, Italy.
- Egbe AC Deparment of Medicine, Division of Cardiovascular Diseases, Mayo Clinic, Rochester, New York, USA.
- Schwerzmann M Adult Congenital Heart Diseae Program, University Hospital Inselspital, Bern, Switzerland.
- Broberg C Knight Cardiovascular Institute, Oregon Health & Sciences University, Portland, Oregon, USA.
- Morissens M Department of Cardiology, CHU Brugmann, Brussels, Belgium.
- Buber J Heart Center, Sheba Medical Center, Ramat Gan, Israel.
- Tsai S Department of Cardiology, University of Nebraska Medical Centre, Omaha, Nebraska, USA.
- Polyzois I Adult Congenital Heart Centre and Centre for Pulmonary Hypertension, Royal Brompton Hospital, London, UK.
- Post MC Department of Cardiology, St Antonius Hospital, Nieuwegein, The Netherlands.
- Greutmann M Cardiology, University Hospital Zurich, Zurich, Switzerland.
- Van Dijk A Cardiology, Nijmegen University Medical Center, Nijmegen, The Netherlands.
- Mulder BJ Cardiology, Academic Medical Center, Amsterdam, The Netherlands.
- Aboulhosn J Cardiology, UCLA, Los Angeles, California, USA.
- 2019-06-28
Published in:
- Open heart. - 2019
English
Background
In Fontan patients with atrial arrhythmias (AA), non-vitamin K antagonist oral anticoagulants(NOACs) have a class III recommendation according to the Pediatric & Congenital Electrophysiology Society (PACES)/Heart Rhythm Society (HRS) guideline in 2014, due to lack of data on outcomes as opposed to evidence of harm. To address this gap in data, we investigated the safety and efficacy of NOACs in adults with a Fontan circulation in a worldwide study.
Methods
This is an international multicentre prospective cohort study, using data from the NOTE (non-vitamin K antagonist oral anticoagulants for thromboembolic prevention in patients with congenital heart disease) registry. The study population comprised consecutive adults with a Fontan circulation using NOACs. Follow-up took place at 6 months and yearly thereafter. The primary endpoints were thromboembolism and major bleeding. Secondary endpoint was minor bleeding.
Results
From April 2014 onward, 74 patients (mean age 32±10 years (range 18-68), 54% male) with a Fontan circulation using NOACs were included. During a median follow-up of 1.2 (IQR 0.8-2.0) years, three thromboembolic events (2.9 per 100 patient-years (95% CI 0.7 to 7.6)) and three major bleedings (2.9 per 100 patient-years (95% CI 0.7 to 7.6)) occurred in five atriopulmonary Fontan and one total cavopulmonary connection Fontan patients with AA. Fifteen patients experienced minor bleeding episodes (15.8 per 100 patient-years (95% CI 9.1 to 25.2)). In patients (n=37) using vitamin K antagonists (VKAs) prior to the initiation of NOAC, annual incidence of historical thromboembolic events and major bleeding were 2.4% (95% CI 0.4% to 7.4%) (n = 2) and 1.2% (95% CI 0.7% to 5.1%) (n = 1), respectively.
Conclusions
In this review of the largest Fontan cohort using NOACs with prospective follow-up, NOACs appear to be well tolerated and their efficacy and safety during short-term follow-up seem comparable to VKAs. Longer term data are required to confirm these promising short-term results.
In Fontan patients with atrial arrhythmias (AA), non-vitamin K antagonist oral anticoagulants(NOACs) have a class III recommendation according to the Pediatric & Congenital Electrophysiology Society (PACES)/Heart Rhythm Society (HRS) guideline in 2014, due to lack of data on outcomes as opposed to evidence of harm. To address this gap in data, we investigated the safety and efficacy of NOACs in adults with a Fontan circulation in a worldwide study.
Methods
This is an international multicentre prospective cohort study, using data from the NOTE (non-vitamin K antagonist oral anticoagulants for thromboembolic prevention in patients with congenital heart disease) registry. The study population comprised consecutive adults with a Fontan circulation using NOACs. Follow-up took place at 6 months and yearly thereafter. The primary endpoints were thromboembolism and major bleeding. Secondary endpoint was minor bleeding.
Results
From April 2014 onward, 74 patients (mean age 32±10 years (range 18-68), 54% male) with a Fontan circulation using NOACs were included. During a median follow-up of 1.2 (IQR 0.8-2.0) years, three thromboembolic events (2.9 per 100 patient-years (95% CI 0.7 to 7.6)) and three major bleedings (2.9 per 100 patient-years (95% CI 0.7 to 7.6)) occurred in five atriopulmonary Fontan and one total cavopulmonary connection Fontan patients with AA. Fifteen patients experienced minor bleeding episodes (15.8 per 100 patient-years (95% CI 9.1 to 25.2)). In patients (n=37) using vitamin K antagonists (VKAs) prior to the initiation of NOAC, annual incidence of historical thromboembolic events and major bleeding were 2.4% (95% CI 0.4% to 7.4%) (n = 2) and 1.2% (95% CI 0.7% to 5.1%) (n = 1), respectively.
Conclusions
In this review of the largest Fontan cohort using NOACs with prospective follow-up, NOACs appear to be well tolerated and their efficacy and safety during short-term follow-up seem comparable to VKAs. Longer term data are required to confirm these promising short-term results.
- Language
-
- English
- Open access status
- gold
- Identifiers
-
- DOI 10.1136/openhrt-2018-000985
- PMID 31245011
- Persistent URL
- https://sonar.ch/global/documents/155900
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