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

Gilles Montalescot*, Carlos Brotons, Bernard Cosyns, Harry J. Crijns, Armando D'Angelo, Ludovic Drouet, Franz Eberli, Deirdre A. Lane, Bruno Besse, Anthony Chan, Eric Vicaut, Harald Darius, AEGEAN Study Investigators

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

14 Citations (Web of Science)

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.

Original languageEnglish
Pages (from-to)61-71
Number of pages11
JournalAmerican Journal of Cardiovascular Drugs
Volume20
Issue number1
DOIs
Publication statusPublished - Feb 2020

Keywords

  • ORAL ANTICOAGULANTS
  • MEDICATION ADHERENCE
  • PATIENT ADHERENCE
  • HEART-FAILURE
  • THERAPY
  • WARFARIN
  • DABIGATRAN
  • MANAGEMENT
  • INTERVENTION
  • PERSISTENCE

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