What is the clinical evidence from this study?

Study design: Cohort. Population: Tetralogy of Fallot and Pulmonary Atresia with Intact Ventricular Septum with Atrial Fibrillation (n=300). Intervention: Direct Oral Anticoagulants (DOACs) vs. Warfarin. Primary outcome: Major bleeding events (HR 5.89, 95% CI 2.81-12.35, p=<0.001).

May 25, 2025Open Access

Atrial Arrhythmia in Patients with Tetralogy of Fallot and Pulmonary Atresia with Intact Ventricular Septum: Risk of Thromboembolism and Bleeding

Q: What are the key findings of this study?

In patients with tetralogy of Fallot or pulmonary atresia with intact ventricular septum and atrial fibrillation, DOAC use was associated with a nearly six-fold increase in major bleeding events compared to warfarin (HR 5.89).

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Why the study?

Adults with congenital heart disease, particularly ToF and PA-IVS, have an increased risk of AF and complications, but their thromboembolic and bleeding risks and risk score utility require evaluation.

Does DOAC use compared to warfarin affect bleeding risk in patients with Tetralogy of Fallot or pulmonary atresia with intact ventricular septum and atrial fibrillation?

Population

300 patients with ToF-PS, ToF-PA, or PA-IVS and AF across Mayo Clinic sites

Comparison

DOAC use vs warfarin

Design

Retrospective cohort study

Key result

In patients with tetralogy of Fallot or pulmonary atresia with intact ventricular septum and atrial fibrillation, DOAC use was associated with a nearly six-fold increase in major bleeding events compared to warfarin (HR 5.89).

Authors

MOMichael O’Shea SKSuganya Arunachalam Karikalan SRSrekar Ravi

Discussion

Member takes

Overview

CHA2DS2-VASc and HAS-BLED may stratify TE and bleeding risk in ToF/PA-IVS with AF; leaves open dedicated validation before clinical use.

Study Design

Type

Cohort (n=300)

Multicenter

Yes

Structured PICO

Does DOAC use compared to warfarin affect bleeding risk in patients with Tetralogy of Fallot or pulmonary atresia with intact ventricular septum and atrial fibrillation?

Population

300 patients with tetralogy of Fallot or pulmonary atresia with intact ventricular septum and atrial fibrillation, followed for a mean of 6.38 to 7.94 years.

Exposure

Direct oral anticoagulants (DOACs)

Comparator

Warfarin

Outcome

Thromboembolism (stroke, TIA, systemic embolism) and major bleedinghard clinical

Main Result

Hazard Ratio: 5.89 (95% CI 2.81–12.35)

Absolute Event Rate: 18.84% vs 3.52%

p-value: p=<0.001

In patients with Tetralogy of Fallot or pulmonary atresia with intact ventricular septum and atrial fibrillation, DOACs are associated with a significantly higher bleeding risk compared to warfarin, suggesting warfarin may be the safer anticoagulant in this population.

Limitations

Relatively small number of people taking specific DOACs prevented DOAC-specific sub-group analysis.
Multivariable regression was not performed due to data sparsity, low prevalence of many binary variables, and low overall event rates.
Retrospective design carries a risk of inadvertently assuming an association is present when it is not.

Cite This Study

O’Shea et al. (2025) conducted a cohort in Tetralogy of Fallot and Pulmonary Atresia with Intact Ventricular Septum with Atrial Fibrillation (n=300). Direct Oral Anticoagulants (DOACs) vs. Warfarin was evaluated on Major bleeding events (HR 5.89, 95% CI 2.81-12.35, p=<0.001). In patients with tetralogy of Fallot or pulmonary atresia with intact ventricular septum and atrial fibrillation, DOAC use was associated with a nearly six-fold increase in major bleeding events compared to warfarin (HR 5.89).

synapsesocial.com/papers/6a97b92b161d47660415d87a https://doi.org/10.1101/2025.05.21.25328122

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May 25, 2025Open Access

Atrial Arrhythmia in Patients with Tetralogy of Fallot and Pulmonary Atresia with Intact Ventricular Septum: Risk of Thromboembolism and Bleeding

View Full Paper

Ask AI

Bookmark

Why the study?

Does DOAC use compared to warfarin affect bleeding risk in patients with Tetralogy of Fallot or pulmonary atresia with intact ventricular septum and atrial fibrillation?

Population

300 patients with ToF-PS, ToF-PA, or PA-IVS and AF across Mayo Clinic sites

Comparison

DOAC use vs warfarin

Design

Retrospective cohort study

Key result

Authors

MOMichael O’Shea SKSuganya Arunachalam Karikalan SRSrekar Ravi

Discussion

Member takes

Overview

CHA2DS2-VASc and HAS-BLED may stratify TE and bleeding risk in ToF/PA-IVS with AF; leaves open dedicated validation before clinical use.

Study Design

Type

Cohort (n=300)

Multicenter

Yes

Structured PICO

Does DOAC use compared to warfarin affect bleeding risk in patients with Tetralogy of Fallot or pulmonary atresia with intact ventricular septum and atrial fibrillation?

Population

300 patients with tetralogy of Fallot or pulmonary atresia with intact ventricular septum and atrial fibrillation, followed for a mean of 6.38 to 7.94 years.

Exposure

Direct oral anticoagulants (DOACs)

Comparator

Warfarin

Outcome

Thromboembolism (stroke, TIA, systemic embolism) and major bleedinghard clinical

Main Result

Hazard Ratio: 5.89 (95% CI 2.81–12.35)

Absolute Event Rate: 18.84% vs 3.52%

p-value: p=<0.001

Limitations

Relatively small number of people taking specific DOACs prevented DOAC-specific sub-group analysis.
Multivariable regression was not performed due to data sparsity, low prevalence of many binary variables, and low overall event rates.
Retrospective design carries a risk of inadvertently assuming an association is present when it is not.

Cite This Study

synapsesocial.com/papers/6a97b92b161d47660415d87a https://doi.org/10.1101/2025.05.21.25328122

Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

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