Abstract
Diabetes mellitus (DM) is a chronic metabolic disease which is independently associated with unfavorable clinical outcomes in patients with atrial fibrillation (AF). Few real-world data are available about the clinical performance of non-vitamin K oral anticoagulants (NOACs) among patients with atrial fibrillation and diabetes. The aim of our propensity score-matched cohort study was to compare the safety and effectiveness of Edoxaban versus well-controlled vitamin K antagonists (VKAs) therapy among this population. In this study, we considered patients with AF and diabetes on Edoxaban or VKAs therapy included in the multicenter Atrial Fibrillation Research Database (NCT03760874). The occurrence of major bleedings (MB) and thromboembolic events (a composite of ischemic stroke, transient ischemic attack, systemic embolism) was respectively considered primary safety and effectiveness outcome. We identified 557 AF patients with diabetes who received Edoxaban (n: 230) or VKAs (n: 327) treatment. After propensity score matching analysis, 135 Edoxaban and 135 VKA recipients with similar clinical characteristics were evaluated. The mean follow-up was 27 ± 3 months. The incidence rate of thromboembolic events (TE) was 3.0 per 100 person-years (1.11 in Edoxaban vs. 1.9 in the VKA group, hazard ratio (HR): 0.59; 95% confidence interval (CI), 0.14 to 2.52; p = 0.48). The incidence rate of major bleedings (MB) was 3.7 per 100 person-years (1.2 in Edoxaban vs. 2.7 in the VKA group, HR: 0.43; 95% CI: 0.10 to 1.40; p = 0.14). The incidence rate of intracranial hemorrhage was 0.35 per 100 person-years in Edoxaban vs. 0.74 in the VKA group (HR: 0.49; 95% CI: 0.05 to 5.54; p = 0.56). A positive net clinical benefit (NCB) of Edoxaban over VKAs was found (+1.39). Insulin therapy (HR: 1.76, p = 0.004) and glycated hemoglobin (HR: 1.17, p = 0.002) were found to be independent predictors of TE; moreover, the concomitant use of antiplatelet drugs (HR: 2.41, p = 0.001) was an independent predictor of MB. Conclusions: Our data support the hypothesis of the safety and efficacy of Edoxaban for use in patients with AF and diabetes, justified by a favorable NCB over VKAs.
Highlights
Diabetes mellitus (DM) is a chronic metabolic disease independently associated with atrial fibrillation (AF) development [1,2], especially in long-lasting diabetes and in the presence of reduced glycemic control [3]
We identified 557 patients with non-valvular AF and diabetes who received Edoxaban or vitamin K antagonists (VKAs) treatment
Propensity score matching identified 135 Edoxaban (EDO) and 135 VKA recipients who were comparable with respect to demographic and clinical characteristics
Summary
Diabetes mellitus (DM) is a chronic metabolic disease independently associated with AF development [1,2], especially in long-lasting diabetes and in the presence of reduced glycemic control [3]. The concomitance of AF and DM leads to higher hospitalization rates, worse clinical cardiovascular mortality, and lower quality of life compared to AF patients without diabetes [4]. According to the current guidelines, a direct oral anticoagulant (DOAC) is preferred over a vitamin K antagonist (VKA) when oral anticoagulation is initiated in eligible AF patients with diabetes [7]. A randomized control trial (RCT) subanalysis showed Edoxaban, a once-daily oral direct XA inhibitor, had similar efficacy compared to warfarin, while reducing bleeding and cardiovascular mortality, irrespective of diabetes [8]; currently, there are no real-world studies supporting these results. The aim of our propensity score-matched cohort study was to compare the safety and effectiveness of Edoxaban versus well-controlled VKAs therapy among AF patients with diabetes with atrial fibrillation in a real-world setting
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