Clinical research in cardiology : official journal of the German Cardiac Society · 2025
Real-world use of direct oral anticoagulants in atrial fibrillation patients with moderate/severe chronic kidney disease: a propensity score matched analysis from the START registry.
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Menichelli Danilo, Gazzaniga Gianluca, Poli Daniela, Palareti Gualtiero, Antonucci Emilia, Pani Arianna, Pignatelli Pasquale, Pastori Daniele, START2 Register Investigators
Аннотация
BACKGROUND: Chronic kidney disease (CKD) often coexists in patients with atrial fibrillation (AF), worsening patients' prognosis. Direct oral anticoagulants (DOACs) are increasingly used also in patients with AF and CKD, but limited evidence exists regarding outcomes in advanced CKD.
METHODS: Patients with AF and CKD from the Italian prospective nationwide START registry were included. Patients were divided into three groups based on the estimated glomerular filtration rate (eGFR): (1) eGFR 59-46, (2) 45-30, and (3) 29-15 ml/min/1.73 m2. The association of DOACs or vitamin K antagonists (VKAs) use with all-cause mortality, cardiovascular events (CVEs), and bleedings was assessed using Cox regression and Fine-Gray competing risk models. Propensity score matching (PSM) was used to confirm the robustness of the analysis.
RESULTS: Among 4849 patients with AF and CKD, the mean age was 81.5 ± 6.7 years, 57.9% were women, and 55.8% were on DOACs. DOAC (vs. VKAs) was inversely associated with all-cause mortality in group 1 (HR 0.49, 95% CI 0.36-0.67, p < 0.001), group 2 (HR 0.42, 95% CI 0.31-0.58, p < 0.001), and group 3 (HR 0.20, 95% CI 0.10-0.39, p < 0.001). Similar results were obtained for CVEs (sHR 0.64, 95% CI 0.49-0.85, p = 0.002 for group 1, sHR 0.56, 95% CI 0.42-0.75, p < 0.001 for group 2, sHR 0.31, 95% CI 0.17-0.55, p < 0.001 for group 3), while no differences emerged for bleedings. No significant differences were observed among DOACs.
CONCLUSIONS: In this real-world contemporary cohort of patients with AF receiving oral anticoagulants, DOAC use was associated with a lower risk of all-cause mortality and cardiovascular events across all stages of CKD. Trial registration NCT02219984.
METHODS: Patients with AF and CKD from the Italian prospective nationwide START registry were included. Patients were divided into three groups based on the estimated glomerular filtration rate (eGFR): (1) eGFR 59-46, (2) 45-30, and (3) 29-15 ml/min/1.73 m2. The association of DOACs or vitamin K antagonists (VKAs) use with all-cause mortality, cardiovascular events (CVEs), and bleedings was assessed using Cox regression and Fine-Gray competing risk models. Propensity score matching (PSM) was used to confirm the robustness of the analysis.
RESULTS: Among 4849 patients with AF and CKD, the mean age was 81.5 ± 6.7 years, 57.9% were women, and 55.8% were on DOACs. DOAC (vs. VKAs) was inversely associated with all-cause mortality in group 1 (HR 0.49, 95% CI 0.36-0.67, p < 0.001), group 2 (HR 0.42, 95% CI 0.31-0.58, p < 0.001), and group 3 (HR 0.20, 95% CI 0.10-0.39, p < 0.001). Similar results were obtained for CVEs (sHR 0.64, 95% CI 0.49-0.85, p = 0.002 for group 1, sHR 0.56, 95% CI 0.42-0.75, p < 0.001 for group 2, sHR 0.31, 95% CI 0.17-0.55, p < 0.001 for group 3), while no differences emerged for bleedings. No significant differences were observed among DOACs.
CONCLUSIONS: In this real-world contemporary cohort of patients with AF receiving oral anticoagulants, DOAC use was associated with a lower risk of all-cause mortality and cardiovascular events across all stages of CKD. Trial registration NCT02219984.