Real-life Performance of Edoxaban in Elderly Patients With Atrial Fibrillation: a Multicenter Propensity Score–Matched Cohort Study

Russo, Vincenzo; Attena, Emilio; Mazzone, Carmine; Melillo, Enrico; Rago, Anna; Galasso, Gennaro; Riegler, Lucia; Parisi, Valentina; Rotunno, Raffaele; Nigro, Gerardo; D’Onofrio, Antonio

doi:10.1016/j.clinthera.2019.04.041

Cited by 30 publications

(22 citation statements)

References 19 publications

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“…Among our study population, a trend in reduction of both thromboembolic and major bleeding events, including ICH, was observed in AF patients with diabetes on Edoxaban versus VKAs therapy. These results support the hypothesis of a better net clinical benefit of Edoxaban vs. VKAs in AF patients with diabetes, as previously shown in elderly patients [ 18 ]; however, our preliminary results need to be confirmed in a larger population.…”

Section: Discussionsupporting

confidence: 91%

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

Russo

Attena²,

Rago

et al. 2020

JCM

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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.

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Section: Discussionsupporting

confidence: 91%

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

Russo

Attena²,

Rago

et al. 2020

JCM

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“…NOACs are safe and effective alternatives to VKA therapy [46,47,48,49], and are currently considered as first-line therapy for long-term stroke prevention in patients with nonvalvular AF [6]. The overall safety and efficacy profile of NOACs have been confirmed in different clinical scenarios [50,51,52,53,54,55,56,57,58]. The clinical performance of NOACs in the setting of acute and elective CV has been addressed by three prospective randomized trials.…”

Section: Prevention and Treatment Of Left Atrial Appendage Thrombosismentioning

confidence: 99%

Diagnosis and Management of Left Atrium Appendage Thrombosis in Atrial Fibrillation Patients Undergoing Cardioversion

et al. 2019

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Atrial fibrillation is the most common cardiac arrhythmia and is associated with an increased risk of stroke and thromboembolic complications. A rhythm control strategy with both electrical and pharmacological cardioversion is recommended for patients with symptomatic atrial fibrillation. Anticoagulant therapy for 3–4 weeks prior to cardioversion is recommended in order to avoid thromboembolic events deriving from restoring sinus rhythm. Transesophageal echocardiography has a pivotal role in this setting, excluding the presence of left atrial appendage thrombus before cardioversion. The aim of this review is to discuss the epidemiology and risk factors for left atrial appendage thrombosis, the role of echocardiography in the decision making before cardioversion, and the efficacy of different anticoagulant regimens on the detection and treatment of left atrial appendage thrombosis.

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“…[16][17][18][19] Older people are more likely to be underweight than young adults and are susceptible to rapid weight loss in response to illness, stress and the ageing process itself; therefore, the low body weight is a frequent comorbidity among elderly, which exposes the patients at an increased greater risk of mortality than those who are overweigh. 6,20 Based on data emerged from randomized clinical trials 8,21,22 and real-world experiences, [23][24][25] NOACs shows a better net clinical benefit vs VKAs among octogenarians with AF: in a recent study, our group compared the safety and efficacy of NOACs versus well-controlled VKA therapy among octogenarians with AF. 24 NCB is a quantitative method that compares the overall change in the drug benefits and risks over a comparator and creates a composite outcome encompassing both drug efficacy and safety in a single quantitative and intuitive measure.…”

Section: Discussionmentioning

confidence: 99%

Non‐vitamin K vs vitamin K oral anticoagulants in patients aged > 80 year with atrial fibrillation and low body weight

Russo

Attena

Maio

et al. 2020

Eur J Clin Investigation

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Atrial fibrillation (AF) prevalence increases with age, making it the most common arrhythmia in patients older than 65 years; among octogenarians the corresponding rate is approximately 10% 1 and the annual risk of stroke increases to up to 23.5% in high-risk patients. 2 Age is an overlapping factor in both the CHA2DS2-VASc score for stroke 3 and the HASBLED score for bleeding risk 4 ; therefore, elderly patients are at higher risk of both ischaemic and bleeding

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Real-life Performance of Edoxaban in Elderly Patients With Atrial Fibrillation: a Multicenter Propensity Score–Matched Cohort Study

Cited by 30 publications

References 19 publications

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

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

Diagnosis and Management of Left Atrium Appendage Thrombosis in Atrial Fibrillation Patients Undergoing Cardioversion

Non‐vitamin K vs vitamin K oral anticoagulants in patients aged > 80 year with atrial fibrillation and low body weight

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