Skip to main content

Advertisement

SpringerLink
Log in

Non-VKA Oral Anticoagulants in Adult Congenital Heart Disease: a Single-Center Study

  • Original Article
  • Published:
Cardiovascular Drugs and Therapy Aims and scope Submit manuscript

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

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

References

  1. Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014;383(9921):955–62.

    Article  CAS  PubMed  Google Scholar 

  2. Freisinger E, Gerß J, Makowski L, et al. Current use and safety of novel oral anticoagulants in adults with congenital heart disease: results of a nationwide analysis including more than 44 000 patients. Eur Heart J. 2020;41(43):4168–77.

    Article  CAS  PubMed  Google Scholar 

  3. Jensen A, Idorn L, Nørager B, et al. Anticoagulation in adults with congenital heart disease: the who, the when and the how. Heart. 2015;101(6):424–9.

    Article  CAS  PubMed  Google Scholar 

  4. Mekaj Y, Mekaj A, Duci S, Miftari E. New oral anticoagulants: their advantages and disadvantages compared with vitamin K antagonists in the prevention and treatment of patients with thromboembolic events. Ther Clin Risk Manag. 2015;11:967–77.

    Article  PubMed  PubMed Central  Google Scholar 

  5. Yang H, Veldtman G, Bouma B, et al. Non-vitamin K antagonist oral anticoagulants in adults with a Fontan circulation: are they safe. Heart. 2019;6(1):e000985.

    Google Scholar 

  6. Almutairi A, Zhou L, Gellad W, et al. Effectiveness and safety of non-vitamin K antagonist oral anticoagulants for atrial fibrillation and venous thromboembolism: a systematic review and meta-analyses. Clin Ther. 2017;39(7):1456–78.

    Article  CAS  PubMed  Google Scholar 

  7. Khairy P, Aboulhosn J, Broberg C, et al. Anticoagulation therapy in congenital heart disease (TACTIC) investigators and the alliance for adult research in congenital cardiology (AARCC). Thromboprophylaxis for atrial arrhythmias in congenital heart disease: a multicenter study. Int J Cardiol. 2016;15(223):729–35.

    Article  Google Scholar 

  8. Stalikas N, Doundoulakis I, Karagiannidis E, et al. Non-vitamin K oral anticoagulants in adults with congenital heart disease: a systematic review. J Clin Med. 2020;9(6):1794.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  9. Yang H, Bouma B, Dimopoulos K, et al. Non-vitamin K antagonist oral anticoagulants (NOACs) for thromboembolic prevention, are they safe in congenital heart disease? Results of a worldwide study. Int J Cardiol. 2020;299(299):123–30.

    Article  CAS  PubMed  Google Scholar 

  10. Baumgartner H, De Backer J, Babu-Narayan S, et al. 2020 ESC Guidelines for the management of adult congenital heart disease: the task force for the management of adult congenital heart disease of the European Society of Cardiology (ESC). Eur Heart J. 2020;42(6):563–645.

    Article  Google Scholar 

  11. Stout K, Daniels C, Aboulhosn J, et al. 2018 AHA/ACC guideline for the management of adults with congenital heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;139(14):698-e800.

    Google Scholar 

  12. Mongeon F, Macle L, Beauchesne L, et al. Non-vitamin K antagonist oral anticoagulants in adult congenital heart disease. Can J Cardiol. 2019;35(12):1686–97.

    Article  PubMed  Google Scholar 

  13. Pujol C, Niesert A, Engelhardt A, et al. Usefulness of direct oral anticoagulants in adult congenital heart disease. Am J Cardiol. 2016;117(3):450–5.

    Article  CAS  PubMed  Google Scholar 

  14. Heidendael J, Bokma J, de Groot J, Koolbergen D, Mulder B, Bouma B. Weighing the risks: thrombotic and bleeding events in adults with atrial arrhythmias and congenital heart disease. Int J Cardiol. 2015;186:315–20.

    Article  CAS  PubMed  Google Scholar 

  15. Pujol C, Müssigmann M, Schiele S, et al. Direct oral anticoagulants in adults with congenital heart disease - a single center study. Int J Cardiol. 2020;1(300):127–31.

    Article  Google Scholar 

  16. Georgekutty J, Kazerouninia A, Wang Y, et al. Novel oral anticoagulant use in adult Fontan patients: a single center experience. Congenit Hear Dis. 2018;13(3):541–7.

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Cardiology, Santa Marta Hospital, Centro Hospitalar Universitário de Lisboa Central, Rua de Santa Marta, n.50, 1169-024, Lisbon, Portugal

    Pedro Garcia Brás, Tânia Branco Mano, Alexandra Castelo, Vera Ferreira, Ana Agapito, Rui Cruz Ferreira & Lídia de Sousa

  2. Department of Pediatric Cardiology, Santa Marta Hospital, Centro Hospitalar Universitário de Lisboa Central, Lisbon, Portugal

    Tiago Rito & Fatima Pinto

Authors
  1. Pedro Garcia Brás
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Tânia Branco Mano
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Tiago Rito
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Alexandra Castelo
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Vera Ferreira
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Ana Agapito
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Rui Cruz Ferreira
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Fatima Pinto
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Lídia de Sousa
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

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.

Corresponding author

Correspondence to Pedro Garcia Brás.

Ethics declarations

Ethics Approval

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.

Consent for Publication

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).

Conflict of Interest

The authors declare no competing interests.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

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

Download citation

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10557-022-07357-5

Keywords

Search

Navigation