Educational Impact on Apixaban Adherence in Atrial Fibrillation (the AEGEAN STUDY): A Randomized Clinical Trial



Montalescot, Gilles, Brotons, Carlos, Cosyns, Bernard, Crijns, Harry J, D'Angelo, Armando, Drouet, Ludovic, Eberli, Franz, Lane, Deirdre A ORCID: 0000-0002-5604-9378, Besse, Bruno, Chan, Anthony
et al (show 2 more authors) (2020) Educational Impact on Apixaban Adherence in Atrial Fibrillation (the AEGEAN STUDY): A Randomized Clinical Trial. AMERICAN JOURNAL OF CARDIOVASCULAR DRUGS, 20 (1). pp. 61-71.

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Abstract

<h4>Introduction</h4>Adherence to non-vitamin-K oral anticoagulants (NOACs) may be lower than to vitamin K antagonists because NOACs do not require routine monitoring.<h4>Objective</h4>We assessed the impact of an educational program on adherence and persistence with apixaban in patients with non-valvular atrial fibrillation (NVAF).<h4>Methods</h4>Patients with NVAF eligible for NOACs with one or more stroke risk factor (prior stroke/transient ischemic attack, age ≥ 75 years, hypertension, diabetes, or symptomatic heart failure) were randomized (1:1) to standard of care (SOC) or SOC with additional educational (information booklet, reminder tools, virtual clinic access). The primary outcome was adherence to apixaban (2.5 or 5 mg twice daily) at 24 weeks. Patients receiving the educational program were re-randomized (1:1) to continue the program for 24 further weeks or to switch to secondary SOC. Implementation adherence and persistence were reassessed at 48 weeks.<h4>Results</h4>In total, 1162 patients were randomized (SOC, 583; educational program, 579). Mean implementation adherence ± standard deviation (SD) at 24 weeks was 91.6% ± 17.1 for SOC and 91.9% ± 16.1 for the educational program arm; results did not differ significantly between groups at any time-point. At 48 weeks, implementation adherence was 90.4% ± 18.0, 90.1% ± 18.6, and 89.3% ± 18.1 for continued educational program, SOC, and secondary SOC, respectively; and corresponding persistence was 86.1% (95% confidence interval [CI] 81.3-89.7), 85.2% (95% CI 81.5-88.2), and 87.8% (95% CI 83.4-91.1). Serious adverse events were similar across groups.<h4>Conclusion</h4>High implementation adherence and persistence with apixaban were observed in patients with NVAF receiving apixaban. The educational program did not show additional benefits.<h4>Clinical trial registration</h4>This study is registered at ClinicalTrials.gov [NCT01884350].

Item Type: Article
Uncontrolled Keywords: AEGEAN Study Investigators, Humans, Atrial Fibrillation, Vitamin K, Pyrazoles, Pyridones, Fibrinolytic Agents, Anticoagulants, Administration, Oral, Risk Factors, Aged, Female, Male, Stroke, Medication Adherence
Depositing User: Symplectic Admin
Date Deposited: 09 Aug 2019 08:27
Last Modified: 19 Jan 2023 00:36
DOI: 10.1007/s40256-019-00356-2
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3050878