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

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.

Nursing Teleconsultation for the Outpatient Management of Patients with Cardiovascular Disease during COVID-19 Pandemic

“…These data confirm that the pre-specified follow-up schedule for patients in anticoagulant therapy should not be lost during the COVID-19 pandemic, in particular for frail, elderly people with high cardiovascular risk and prevalent comorbidities, such as dyslipidemia and ischemic heart disease. Although NOACs are safer than VKAs in some different clinical settings [ 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 ], an inappropriate dose may predispose to both hemorrhagic and thrombotic events; moreover, the use of any anticoagulant is associated with some drug–drug interactions, which may increase the risk of serious bleeding or diminish stroke protection. The teleconsultation should be oriented to evaluate the blood sampling (including hemoglobin, renal, and liver function); to check the adherence; and to re-assess if the chosen NOAC or its dose is the best for the patient, according to age, weight, or renal function [ 31 , 32 , 33 ].…”

Efficacy and Safety of Direct Oral Anticoagulants in Patients with Diabetes and Nonvalvular Atrial Fibrillation: Meta-Analysis of Observational Studies

“…In six of the included studies [16][17][18][20][21][22], the standard dose and reduced dose of DOACs were prescribed for patients with NVAF and diabetes. However, only three studies [16,17,21] evaluated the efficacy and safety outcomes by subgroup analysis based on dosage.…”

“…In the study of Hsu et al [18], haematuria was included in addition to intracranial bleeding and gastrointestinal bleeding; hence, inconsistency may result in heterogeneity. Second, the propensity score matching method to balance residual confounding was used by six studies [16][17][18][20][21][22] but not by one work [19], and this condition may also lead to heterogeneity. Moreover, two of the selected studies [19,22] had a relatively small sample size and a low number of endpoint events that may limit the statistical power.…”

“…A total of 495 articles were identified through the systemic database search. After the duplicates and studies that did not meet the eligibility criteria were excluded, seven studies [16][17][18][19][20][21][22] were included (Figure S1). The baseline characteristics of selected studies are shown in Supplementary Table S2.…”

Non Vitamin K Antagonist Oral Anticoagulants in Atrial Fibrillation Patients Scheduled for Electrical Cardioversion: A Real-Life Propensity Score Matched Study

“…The safety and efficacy of non-vitamin K antagonist oral anticoagulants (NOACs) in AF patients have been demonstrated in large randomized clinical trials (RCTs) [2][3][4][5] and real-world observational studies, [6][7][8][9][10] resulting in a rapid increase of their use across different clinical scenarios. [11][12][13][14][15][16][17][18][19] Both RCTs post-hoc analyses [20][21][22][23] and observational studies [24][25][26] evaluating the periprocedural use of NOACs in AF patients undergoing EC showed a similar risk of thromboembolic and bleeding events compared to vitamin K antagonists (VKAs). The current guidelines recommend the early use of NOACs before every AF cardioversion.…”