Clinical Outcome of Edoxaban vs. Vitamin K Antagonists in Patients with Atrial Fibrillation and Diabetes Mellitus: Results from a Multicenter, Propensity-Matched, Real-World Cohort Study
Open Access
- 27 May 2020
- journal article
- research article
- Published by MDPI AG in Journal of Clinical Medicine
- Vol. 9 (6), 1621
- https://doi.org/10.3390/jcm9061621
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.This publication has 27 references indexed in Scilit:
- Duration of Diabetes Mellitus and Risk of Thromboembolism and Bleeding in Atrial FibrillationStroke, 2015
- Executive Summary: Heart Disease and Stroke Statistics—2015 UpdateCirculation, 2015
- Heart Disease and Stroke Statistics—2015 UpdateCirculation, 2015
- Cellular and molecular mechanisms of vascular injury in diabetes — Part I: Pathways of vascular disease in diabetesVascular Pharmacology, 2011
- Risks of cardiovascular events and effects of routine blood pressure lowering among patients with type 2 diabetes and atrial fibrillation: results of the ADVANCE studyEuropean Heart Journal, 2009
- The prothrombotic risk of diabetes mellitus in atrial fibrillation and heart failureJournal of Thrombosis and Haemostasis, 2005
- Combined Anticoagulant–Antiplatelet Use and Major Bleeding Events in Elderly Atrial Fibrillation PatientsStroke, 2004
- STROKE PREVENTION: Hypertension, Diabetes, Tobacco, and LipidsNeurologic Clinics, 2000
- Hemostasis Variables in Type I Diabetic Patients Without Demonstrable Vascular ComplicationsDiabetes Care, 1993
- Coagulation and fibrinolytic system impairment in insulin dependent diabetes mellitusThrombosis Research, 1992