International Journal of Cardiology Congenital Heart Disease · Published 2026-06-24 · DOI 10.1016/j.ijcchd.2026.100691
Dennis D. Kumi, George Blankson, Irene Animah Acheampong, Samuel Michael Odoi, Sudhir Mungee, Timir Baman, Amit Mehrotra, Siddharth Shah
Background: 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. Methods: In a propensity score–matched retrospective cohort study using the TriNetX database, adults (age ≥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. Results: 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. Conclusions: 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.
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Kumi, D., Blankson, G., Acheampong, I., et al. (2026). 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. International Journal of Cardiology Congenital Heart Disease. https://doi.org/10.1016/j.ijcchd.2026.100691