Abstract
Background
Pulmonary valve replacement (PVR) in pediatric and young adult populations necessitates effective thromboprophylaxis due to the potential risk of thromboembolic complications. Warfarin, though traditionally used, presents limitations in children due to its narrow therapeutic range and the need for frequent INR monitoring. Rivaroxaban, a direct oral anticoagulant (DOAC), has shown promise in pediatric thrombosis prevention but its safety and efficacy after PVR have not been established.
Methods
In this randomized, double-blind clinical trial, 44 patients aged over 5 years ( The minimum age of our patient was 9 years old) who underwent PVR at a tertiary referral center were randomized to receive either warfarin (0.1–0.3 mg/kg/day with INR monitoring) or rivaroxaban (dosed as Mayo Clinic pediatric guidelines). Patients with prior thrombosis, paradoxical embolism, low ejection fraction, or hypersensitivity to study medications were excluded. Patients were followed for a mean of approximately 6 months, assessed for thromboembolic or hemorrhagic events, and rated their satisfaction with anticoagulation on a 10-point scale. Three patients were lost to follow-up, and 41 were included in the final analysis (warfarin: n = 22; rivaroxaban: n = 19).
Results
No thromboembolic or cerebrovascular events were observed in either group. One patient (4.54%) in the warfarin group developed hemoptysis, later attributed to an arteriovenous malformation, which resolved upon switching to rivaroxaban. Patient satisfaction was significantly higher in the rivaroxaban group (mean score: 8.26 ± 1.99) compared to the warfarin group (5.14 ± 1.09; p < 0.001). Baseline demographics were similar between groups except for weight, which was significantly higher in the rivaroxaban group (p = 0.044).
Conclusion
Rivaroxaban demonstrated comparable efficacy to warfarin in preventing thromboembolic events following PVR in children and young adults, with a favorable safety profile and significantly higher patient satisfaction. These findings support further evaluating rivaroxaban as a viable anticoagulation option in this population.
Trial registration
Registered in the Iranian Registry of Clinical Trials (IRCT): IRCT20220516054868N2. Registration date: 11/30/2023.
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Abbreviations
- ACHD:
-
Adult Congenital Heart Disease
- AVM:
-
Arteriovenous Malformation
- CHD:
-
Congenital Heart Disease
- DOAC:
-
Direct Oral Anticoagulant
- DORV:
-
Double Outlet Right Ventricle
- EF:
-
Ejection Fraction
- INR:
-
International Normalized Ratio
- IRCT:
-
Iranian Registry of Clinical Trials
- NSAIDs:
-
Non-Steroidal Anti-Inflammatory Drugs
- PVR:
-
Pulmonary Valve Replacement
- RCT:
-
Randomized Controlled Trial
- RV:
-
Right Ventricle
- RVOT:
-
Right Ventricular Outflow Tract
- SD:
-
Standard Deviation
- TAPSE:
-
Tricuspid Annular Plane Systolic Excursion
- TFTC:
-
Tetralogy of Fallot Total Correction
- VKA:
-
Vitamin K Antagonist
- VTE:
-
Venous Thromboembolism
Acknowledgments
We thank the patients and their families for their participation. We are grateful to the clinical and administrative staff at the Pediatric Cardiovascular Research Center and participating pediatric cardiology centers in Isfahan for their support with patient follow-up and data collection. Special thanks to the Ethics Committee of Isfahan University of Medical Sciences for oversight. No professional medical writers were used.
Funding
No external funding was received for this study.
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Ethics approval and consent to participate
The study protocol was in agreement with the Declaration of Helsinki and approved by the local ethics committee (Code: IR.MUI.MED.REC.1402.282). Written informed consent was obtained from all participants who were ≥ 18 years old. For participants < 18 years, written informed consent was obtained from a parent or legal guardian, and age-appropriate assent was obtained from the child/adolescent where applicable.
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Not applicable.
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The authors declare no competing interests.
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Sabri, M.R., Dehghan, B., Ghasemi, M. et al. Comparative efficacy and safety of rivaroxaban versus warfarin in patients following pulmonary valve replacement: a randomized controlled trial. BMC Pediatr (2026). https://doi.org/10.1186/s12887-026-07702-9
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DOI: https://doi.org/10.1186/s12887-026-07702-9