Abstract
Purpose
Non-VKA oral anticoagulants (NOACs) prescription is increasing in adults with congenital heart disease (ACHD). However, data on efficacy and safety in ACHD is unclear, particularly in severe CHD. The study aimed to review the safety and efficacy of NOACs in ACHD.
Methods
Retrospective evaluation of ACHD patients started on NOACs from 2014 to 2020, with the primary endpoints of bleeding or thromboembolic events (TE). CHA2DS2-VASc and HAS-BLED scores were calculated, mortality was assessed, and risk factors for bleeding were identified.
Results
A total of 93 patients were included, the mean age was 52 ± 15 years, 58% were female, 55.9% had moderate CHD, and 23.7% had severe CHD (3.2% Fontan). Most (66%) had a CHA2DS2-VASc score ≥ 2 and 82% HAS-BLED ≤ 2. In a median follow-up of 41 (IQR 21) months (400.4 patient-years), there were TE in two patients. The annual risk for TE was 0.49%/patient/year. The cardiovascular mortality was 2% and all-cause mortality 5%; there were no fatal TE or bleeding events. Minor (n = 6, 6.5%) and major (n = 3, 3.2%) bleeding events were observed, a median of 12 (IQR 15) months after starting NOAC therapy. The annual risk for bleeding was 2.2%/patient/year. Renal disease (HR 14.6 [95% CI 1.23–73.6], p = 0.033) and the HAS-BLED score were predictors of major (adjusted HR 6.97 [95% CI 1.69–28.78], p = 0.007) and minor (adjusted HR 3.80 [95% CI 1.48–9.78], p = 0.006) bleeding complications.
Conclusion
In this real-life cohort of selected ACHD, the use of NOACs was safe and effective, with a low incidence of bleeding events.
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Data Availability
The dataset generated during this study is currently not publicly shared as it contains detailed individual patient data, which would compromise patient privacy. The generated dataset is currently accessible to the Santa Marta Hospital, Centro Universitário Hospitalar de Lisboa Central’s Adult Congenital Heart Disease Unit Team.
Abbreviations
- ACHD:
-
Adult congenital heart disease
- AF:
-
Atrial fibrillation
- CT:
-
Computed tomography
- ESC:
-
European Society of Cardiology
- NOAC:
-
Non-VKA oral anticoagulants
- VKA:
-
Vitamin K antagonists
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Original study idea by Ana Agapito and Lídia Sousa. All authors contributed to the study conception and design. Data collection and analysis were performed by Pedro Garcia Brás and Tânia Branco Mano. The first draft of the manuscript was written by Pedro Garcia Brás, and all authors commented on previous versions of the manuscript. Critical revisions were performed by Lídia Sousa. All authors read and approved the final manuscript.
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Ethical approval was waived by the local Ethics Committee (Centro Hospitalar Universitário Lisboa Central) in view of the retrospective nature of the study (conducted on already available digital data, obtained for clinical purposes). This study was performed in accordance with the ethical standards in the 1964 Declaration of Helsinki.
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All patients were contacted (via telephone), and verbal informed consent was obtained prior to collection of the digital data. In the case of deceased patients, a family member or legal representative was contacted for informed consent. This manuscript does not contain any individual person’s data in any form (including any individual details, images or videos).
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Brás, P.G., Mano, T.B., Rito, T. et al. Non-VKA Oral Anticoagulants in Adult Congenital Heart Disease: a Single-Center Study. Cardiovasc Drugs Ther 37, 1077–1086 (2023). https://doi.org/10.1007/s10557-022-07357-5
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DOI: https://doi.org/10.1007/s10557-022-07357-5