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A Multisite Retrospective Review of Direct Oral Anticoagulants Compared to Warfarin in Adult Fontan Patients

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Abstract

Purpose

Direct oral anticoagulants (DOACs) are not recommended in adult Fontan patients (Level of Evidence C). We hypothesized that DOACs are comparable to warfarin and do not increase thrombotic and embolic complications (TEs) or clinically significant bleeds.

Methods

We reviewed the medical records of adult Fontan patients on DOACs or warfarin at three major medical centers. We identified 130 patients: 48 on DOACs and 107 on warfarin. In total, they were treated for 810 months on DOACs and 5637 months on warfarin.

Results

The incidence of TEs in patients on DOACs compared to those on warfarin was not increased in a statistically significant way (hazard ratio [HR] 1.7 and p value 0.431). Similarly, the incidence of nonmajor and major bleeds in patients on DOACs compared to those on warfarin was also not increased in a statistically significant way (HR for nonmajor bleeds in DOAC patients was 2.8 with a p value of 0.167 and the HR for major bleeds was 2.0 with a p value 0.267). In multivariate analysis, congestive heart failure (CHF) was a risk factor for TEs across both groups (odds ratio [OR] = 4.8, 95% confidence interval [CI] = 1.3–17.6) and bleed history was a risk factor for clinically significant bleeds (OR = 6.8, 95% CI = 2.7–17.2).

Conclusion

In this small, retrospective multicenter study, the use of DOACs did not increase the risk of TEs or clinically significant bleeds compared to warfarin in a statistically significant way.

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Available upon request.

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Author information

Authors and Affiliations

  1. Departments of Internal Medicine and Pediatrics, Baylor College of Medicine, Houston, TX, USA

    Amir Kazerouninia

  2. Division of Pediatric Cardiology, Cohen Children’s Medical Center/Northwell Health, New Hyde Park, NY, USA

    Justin Georgekutty

  3. Department of Medicine, Duke University School of Medicine, Durham, NC, USA

    Payton Kendsersky

  4. Departments of Internal Medicine and Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA

    Ryan D. Byrne & Patricia Y. Chu

  5. University of Hawaii, John A. Burns School of Medicine, Honolulu, HI, USA

    Brendan Seto

  6. Division of Pediatric Cardiology, Texas Children’s Hospital/Baylor College of Medicine, Houston, TX, USA

    Yunfei Wang

  7. Departments of Pediatrics and Internal Medicine, Division of Cardiology, Emory University, Atlanta, GA, USA

    Fred H. Rodriguez III, Clayton Smith & Anita Saraf

  8. Sibley Heart Center Cardiology, Atlanta, GA, USA

    Fred H. Rodriguez III, Clayton Smith & Anita Saraf

  9. Department of Internal Medicine, Division of Cardiology, Emory University, Atlanta, GA, USA

    Michael S. Lloyd

  10. Vanderbilt Heart and Vascular Institute, Vanderbilt University Medical Center, Nashville, TN, USA

    Benjamin P. Frischhertz

  11. Division of Adult Congenital Cardiology, Texas Children’s Hospital/Baylor College of Medicine, Houston, TX, USA

    Dhaval R. Parekh, Peter R. Ermis, Wayne J. Franklin & Wilson W. Lam

Authors
  1. Amir Kazerouninia
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  2. Justin Georgekutty
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Contributions

All authors contributed significantly.

Corresponding author

Correspondence to Amir Kazerouninia.

Ethics declarations

Ethics Approval

Not applicable (retrospective chart review only).

Declaration of Helsinki

This study complies with the Declaration of Helsinki. Each institution’s ethics committee approved the research protocol. Due to the retrospective nature of the study, informed consent was not required to be obtained from the subjects.

Consent to Participate

Not applicable (retrospective chart review only).

Consent for Publication

Not applicable (retrospective chart review only).

Conflict of Interest

The authors declare no competing interests.

Additional information

This paper is dedicated to Dr. Justin Georgekutty, a friend and colleague. Without his vision and contributions, this paper would never have been started.

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Supplementary Information

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10557_2021_7298_MOESM1_ESM.pptx

Supp Fig 1. Propensity matching love plot. LV: predominantly systemic left ventricle; RV: predominantly systemic right ventricle; AP: atriopulmonary Fontan subtype; LT:lateral tunnel Fontan subtype; ECC: extracardiac conduit Fontan subtype; Indication:Procedure = coiling, stents, anti-arrythmia, cardioversion; Indication: Other = patentfenestration, right-to-left shunt, cyanosis, decreased ventricular function, prosthetic valve,hypercoagulability; Empiric = Fontan physiology prophylaxis or not documented. (PPTX 230 kb)

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Kazerouninia, A., Georgekutty, J., Kendsersky, P. et al. A Multisite Retrospective Review of Direct Oral Anticoagulants Compared to Warfarin in Adult Fontan Patients. Cardiovasc Drugs Ther 37, 519–527 (2023). https://doi.org/10.1007/s10557-021-07298-5

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  • DOI: https://doi.org/10.1007/s10557-021-07298-5

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