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

Abstract

Introduction Adherence to non-vitamin-K oral anticoagulants (NOACs) may be lower than to vitamin K antagonists because NOACs do not require routine monitoring. Objective We assessed the impact of an educational program on adherence and persistence with apixaban in patients with non-valvular atrial fibrillation (NVAF). Methods 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. Results 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. Conclusion High implementation adherence and persistence with apixaban were observed in patients with NVAF receiving apixaban. The educational program did not show additional benefits. Clinical trial registration This study is registered at ClinicalTrials.gov [NCT01884350]. Bruno Besse: Position at the time of manuscript preparation. No longer an employee of Bristol-Myers Squibb. The full list of AEGEAN Investigators is given in the Electronic Supplementary Material.

Reducing Stroke Risk in Atrial Fibrillation: Adherence to Guidelines Has Improved, but Patient Persistence with Anticoagulant Therapy Remains Suboptimal

“…In that study, significantly higher proportions of patients were appropriately prescribed OAC in the intervention group at 6-months and 1-year 98). However, the AEGEAN study looked at the effect of additional education on adherence to apixaban over 48 weeks, however failed to find an improvement 99). Patients were randomised to standard care only, or standard care plus an education package which included a selection of reminder apps and access to a virtual clinic 99).…”

“…However, the AEGEAN study looked at the effect of additional education on adherence to apixaban over 48 weeks, however failed to find an improvement 99). Patients were randomised to standard care only, or standard care plus an education package which included a selection of reminder apps and access to a virtual clinic 99). Both groups were followed up every 12-weeks to determine medication adherence, and at 48 weeks there was no difference between additional education and standard care (90.4% vs. 90.1%) 99).…”

Use, Persistence, Efficacy, and Safety of Apixaban in Patients with Non-Valvular Atrial Fibrillation in Unselected Patients in Germany. Results of the Prospective Apixaban in Atrial Fibrillation (APAF) Registry

“…A retrospective analysis of primary care data in Germany reports about a persistence to apixaban after 1 year in 62.9% with apixaban and 57.5% with VKAs [ 16 ]. In the randomized AEGEAN study investigating the effect of an educational program on the adherence and persistence to apixaban therapy, adherence and persistence with apixaban therapy after 48 months was about 90% and 86%, respectively [ 17 ]. This matches favorably with our experience, in which we observed an 88% persistence to apixaban after 12 months.…”

The year in cardiology: arrhythmias and pacing

“…34 One trial, AEGEAN showed high adherence and persistence with apixaban (90%) but did not show additional benefit from interventions to improve adherence/persistence. 35 Also, studies of NOAC use in extremes of renal function, both severe renal impairment and supra-normal renal function. The latter is pertinent given that all three Factor Xa inhibitors showed numerically more ischaemic strokes in the subgroup with CrCl >95 mL/min when compared with warfarin in their pivotal trials, although this is not apparent in real-world observational data.…”