Comparative efficacy and safety of direct oral anticoagulants versus warfarin in non-valvular atrial fibrillation patients with adult congenital heart disease. Contemporary real-world propensity-matched retrospective cohort study.

Authors

Dennis D Kumi, George Blankson, Irene Animah Acheampong, Samuel Michael Odoi, Sudhir Mungee, Timir Baman, Amit Mehrotra, Siddharth Shah

Published in

International journal of cardiology. Congenital heart disease. Volume 25. Pages 100691. Epub Jun 24, 2026.

Abstract

Adults with congenital heart disease (ACHD) have a rising prevalence of atrial fibrillation/flutter (AF) and elevated thrombotic and bleeding risk. Although direct oral anticoagulants (DOACs) are established in non-ACHD AF, comparative effectiveness in ACHD is not well defined.
In a propensity score-matched retrospective cohort study using the TriNetX database, adults (age $\ge 18)$ with ACHD and AF receiving oral anticoagulation were identified, excluding those with mechanical valves, LVAD, antiphospholipid syndrome, or rheumatic mitral stenosis. Patients were matched 1:1 to DOAC or warfarin. The primary outcomes were composite embolic events, composite bleeding events, and net clinical outcome (embolism, bleeding, or all-cause mortality). Secondary outcomes included gastrointestinal bleeding, nontraumatic intracranial hemorrhage (ICH), cardioembolic stroke, systemic arterial embolization, cerebral infarction, and all-cause mortality. Associations were estimated using hazard ratios (HRs). Sensitivity analysis was performed to confirm the robustness of magnitude and direction of outcomes.
After matching, 27,166 patients were included (13,583 per group). DOAC use was associated with lower hazard of net clinical outcome (HR 0.87, 95% CI 0.81-0.93), driven by reduced composite bleeding (HR 0.82, 95% CI 0.75-0.90) and all-cause mortality (HR 0.68, 95% CI 0.64-0.72). Hazard of composite embolic events did not differ (HR 0.94, 95% CI 0.87-1.03). DOACs were associated with lower hazard of systemic arterial embolization (HR 0.62, 95% CI 0.52-0.73), nontraumatic ICH (HR 0.74, 95% CI 0.61-0.90), and gastrointestinal bleeding (HR 0.84, 95% CI 0.76-0.93). No significant differences were observed for cerebral infarction or cardioembolic stroke.
In a large propensity-matched cohort of patients with ACHD and AF, DOAC therapy was associated with lower hazard of net clinical outcome, all bleeding events, and all-cause mortality compared with warfarin, without increased embolic risk.

PMID:
42495574
Bibliographic data and abstract were imported from PubMed on 24 Jul 2026.

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