What is the clinical evidence from this study?

Study design: Cohort. Population: Tetralogy of Fallot and pulmonary atresia with intact ventricular septum and atrial fibrillation (n=300). Intervention: Direct oral anticoagulants (DOACs) vs. Warfarin. Primary outcome: Major bleeding (adjusted HR 5.77, p=<0.001).

What does this research mean for the field?

In adults with Tetralogy of Fallot and pulmonary atresia with intact ventricular septum who have atrial fibrillation, DOAC therapy is associated with a substantially higher major bleeding risk than warfarin, and the CHA2DS2-VASc score effectively predicts thromboembolism while the HAS-BLED score performs poorly. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

To evaluate thromboembolic and major bleeding risks and compare bleeding outcomes between direct oral anticoagulants and warfarin in adults with complex congenital heart disease and atrial arrhythmias.

September 3, 2026Heart Rhythm O2Open Access

DOACs linked to ~477% higher major bleeding risk than warfarin in Tetralogy of Fallot with AF.

Q: What are the key findings of this study?

In adults with Tetralogy of Fallot or pulmonary atresia and atrial fibrillation, DOAC therapy was associated with a higher major bleeding risk than warfarin (adjusted HR 5.77; p<0.001).

Q: What does this research mean for the field?

In adults with Tetralogy of Fallot and pulmonary atresia with intact ventricular septum who have atrial fibrillation, DOAC therapy is associated with a substantially higher major bleeding risk than warfarin, and the CHA2DS2-VASc score effectively predicts thromboembolism while the HAS-BLED score performs poorly. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Q: What question did this study set out to answer?

To evaluate thromboembolic and major bleeding risks and compare bleeding outcomes between direct oral anticoagulants and warfarin in adults with complex congenital heart disease and atrial arrhythmias.

View Full Paper

Ask AI

Bookmark

Why the study?

Adults with complex congenital heart disease have a high prevalence of AF, but thromboembolic and bleeding risks and comparative bleeding outcomes between warfarin and DOACs needed evaluation.

Do direct oral anticoagulants (DOACs) increase major bleeding compared to warfarin in adults with Tetralogy of Fallot or pulmonary atresia with intact ventricular septum and atrial fibrillation?

Population

300 adults with TOF-PS, TOF-PA, or PA-IVS treated for AF

Comparison

DOACs vs warfarin

Design

Retrospective cohort study

Follow-up

Mean 7.9 years

Key result

In adults with Tetralogy of Fallot or pulmonary atresia and atrial fibrillation, DOAC therapy was associated with a higher major bleeding risk than warfarin (adjusted HR 5.77; p<0.001).

Authors

MOMichael P. O’SheaMayo Clinic in Arizona SKSuganya Arunachalam KarikalanMayo Clinic Hospital SRSREKAR RAVIWinnMed

Discussion

Member takes

Overview

May warrant warfarin preference over DOACs in ToF/PA with AF; leaves open need for randomized confirmation in congenital heart disease.

Key Points

To evaluate thromboembolic and major bleeding risks and compare bleeding outcomes between direct oral anticoagulants and warfarin in adults with complex congenital heart disease and atrial arrhythmias.
Retrospective cohort study of adults with tetralogy of Fallot with pulmonary stenosis, tetralogy of Fallot with pulmonary atresia, or pulmonary atresia with intact ventricular septum treated for atrial fibrillation or flutter at Mayo Clinic sites from 1999 to 2023 (N=300; mean follow-up 7.9 years).
Primary outcomes of thromboembolic events (stroke, transient ischemic attack, systemic embolism) and major bleeding were evaluated using multivariable and age-controlled Cox proportional hazards regression models.
Thromboembolic events occurred at an incidence of 5.23 per 1,000 person-years (12 events), with CHA2DS2-VASc score showing good predictive discrimination (c-statistic 0.78).
Major bleeding occurred at an incidence of 3.74 per 100 person-years (69 events), and DOAC therapy was associated with significantly increased major bleeding risk compared to warfarin (adjusted HR 5.77; p<0.001), while HAS-BLED exhibited poor discrimination (c-statistic 0.59).
Major bleeding risk was significantly higher in patients with tetralogy of Fallot with pulmonary atresia versus pulmonary stenosis (HR 2.05; p=0.005) and those with prior Waterston shunts, elevated right atrial pressure, or right ventricular dysfunction.

Study Design

Type

Cohort (n=300)

Multicenter

Yes

Structured PICO

Do direct oral anticoagulants (DOACs) increase major bleeding compared to warfarin in adults with Tetralogy of Fallot or pulmonary atresia with intact ventricular septum and atrial fibrillation?

Population

300 adults with Tetralogy of Fallot or pulmonary atresia with intact ventricular septum treated for atrial fibrillation, followed for a mean of 7.9 years.

Exposure

Direct oral anticoagulants (DOACs)

Comparator

Warfarin

Outcome

Thromboembolic events (stroke, transient ischemic attack, or systemic embolism) and major bleedinghard clinical

Main Result

Hazard Ratio: 5.77

p-value: p=<0.001

In adults with complex congenital heart disease (ToF and PA-IVS) and atrial arrhythmias, DOAC therapy is associated with a significantly higher risk of major bleeding compared to warfarin.

Cite This Study

O’Shea et al. (2026) conducted a cohort in Tetralogy of Fallot and pulmonary atresia with intact ventricular septum and atrial fibrillation (n=300). Direct oral anticoagulants (DOACs) vs. Warfarin was evaluated on Major bleeding (adjusted HR 5.77, p=<0.001). In adults with Tetralogy of Fallot or pulmonary atresia and atrial fibrillation, DOAC therapy was associated with a higher major bleeding risk than warfarin (adjusted HR 5.77; p<0.001).

synapsesocial.com/papers/6a99352e636c6408cfa7d26d https://doi.org/10.1016/j.hroo.2026.08.143

View Full Paper

Ask AI

Bookmark

September 3, 2026Heart Rhythm O2Open Access

DOACs linked to ~477% higher major bleeding risk than warfarin in Tetralogy of Fallot with AF.

View Full Paper

Ask AI

Bookmark

Why the study?

Adults with complex congenital heart disease have a high prevalence of AF, but thromboembolic and bleeding risks and comparative bleeding outcomes between warfarin and DOACs needed evaluation.

Do direct oral anticoagulants (DOACs) increase major bleeding compared to warfarin in adults with Tetralogy of Fallot or pulmonary atresia with intact ventricular septum and atrial fibrillation?

Population

300 adults with TOF-PS, TOF-PA, or PA-IVS treated for AF

Comparison

DOACs vs warfarin

Design

Retrospective cohort study

Follow-up

Mean 7.9 years

Key result

In adults with Tetralogy of Fallot or pulmonary atresia and atrial fibrillation, DOAC therapy was associated with a higher major bleeding risk than warfarin (adjusted HR 5.77; p<0.001).

Authors

MOMichael P. O’SheaMayo Clinic in Arizona SKSuganya Arunachalam KarikalanMayo Clinic Hospital SRSREKAR RAVIWinnMed

Discussion

Member takes

Overview

May warrant warfarin preference over DOACs in ToF/PA with AF; leaves open need for randomized confirmation in congenital heart disease.

Key Points

To evaluate thromboembolic and major bleeding risks and compare bleeding outcomes between direct oral anticoagulants and warfarin in adults with complex congenital heart disease and atrial arrhythmias.
Retrospective cohort study of adults with tetralogy of Fallot with pulmonary stenosis, tetralogy of Fallot with pulmonary atresia, or pulmonary atresia with intact ventricular septum treated for atrial fibrillation or flutter at Mayo Clinic sites from 1999 to 2023 (N=300; mean follow-up 7.9 years).
Primary outcomes of thromboembolic events (stroke, transient ischemic attack, systemic embolism) and major bleeding were evaluated using multivariable and age-controlled Cox proportional hazards regression models.
Thromboembolic events occurred at an incidence of 5.23 per 1,000 person-years (12 events), with CHA2DS2-VASc score showing good predictive discrimination (c-statistic 0.78).
Major bleeding occurred at an incidence of 3.74 per 100 person-years (69 events), and DOAC therapy was associated with significantly increased major bleeding risk compared to warfarin (adjusted HR 5.77; p<0.001), while HAS-BLED exhibited poor discrimination (c-statistic 0.59).
Major bleeding risk was significantly higher in patients with tetralogy of Fallot with pulmonary atresia versus pulmonary stenosis (HR 2.05; p=0.005) and those with prior Waterston shunts, elevated right atrial pressure, or right ventricular dysfunction.

Study Design

Type

Cohort (n=300)

Multicenter

Yes

Structured PICO

Do direct oral anticoagulants (DOACs) increase major bleeding compared to warfarin in adults with Tetralogy of Fallot or pulmonary atresia with intact ventricular septum and atrial fibrillation?

Population

300 adults with Tetralogy of Fallot or pulmonary atresia with intact ventricular septum treated for atrial fibrillation, followed for a mean of 7.9 years.

Exposure

Direct oral anticoagulants (DOACs)

Comparator

Warfarin

Outcome

Thromboembolic events (stroke, transient ischemic attack, or systemic embolism) and major bleedinghard clinical

Main Result

Hazard Ratio: 5.77

p-value: p=<0.001

In adults with complex congenital heart disease (ToF and PA-IVS) and atrial arrhythmias, DOAC therapy is associated with a significantly higher risk of major bleeding compared to warfarin.

Cite This Study

synapsesocial.com/papers/6a99352e636c6408cfa7d26d https://doi.org/10.1016/j.hroo.2026.08.143

View Full Paper

Ask AI

Bookmark