Educational Impact on Apixaban Adherence in Atrial Fibrillation (the AEGEAN STUDY): A Randomized Clinical Trial
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Key result
An additional educational program did not significantly improve implementation adherence to apixaban at 24 weeks compared to standard of care (91.9% vs 91.6%) in patients with non-valvular atrial fibrillation.
Why the study?
Adherence to NOACs may be lower than to vitamin K antagonists because NOACs do not require routine monitoring.
Does an educational program improve adherence to apixaban in patients with non-valvular atrial fibrillation?
Population
1162 patients with NVAF and at least one stroke risk factor
Comparison
Educational program alongside standard of care vs standard of care alone
Design
Randomized clinical trial
Follow-up
48 weeks
Authors
Discussion
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Member takes
Implication
Additional education adds no adherence benefit beyond standard care in NVAF; challenges assumptions that such programs meaningfully improve NOAC persistence.
Study Design
Type
RCT (n=1,162)
Blinding
Double-blind
Randomization
1:1
Multicenter
Yes
Structured PICO
Does an educational program improve adherence to apixaban in patients with non-valvular atrial fibrillation?
P
Population
1,162 patients with non-valvular atrial fibrillation and at least one stroke risk factor, treated with apixaban and followed for up to 48 weeks.
I
Intervention
Standard of care with an additional educational program (information booklet, reminder tools, virtual clinic access) alongside apixaban (2.5 or 5 mg twice daily)
C
Comparator
Standard of care alongside apixaban (2.5 or 5 mg twice daily)
O
Outcome
Adherence to apixaban at 24 weeks
Main Result
Absolute Event Rate: 91.9% vs 91.6%
p-value: p=>0.7
An educational program did not significantly improve the already high adherence and persistence rates to apixaban in patients with non-valvular atrial fibrillation.
Limitations
- Selection bias, as patients willing to participate in an adherence study are more likely to be better adherers
- Patient consent was only obtained after they had already consented to initiating apixaban therapy
- Measuring implementation adherence improves it per se (Hawthorne effect)
- The electronic monitoring device used did not provide instant feedback, which might have influenced overall adherence rates
- Excluded hospitalized patients and those with an increased risk of bleeding, resulting in a relatively stable AF population
Cite This Study
Montalescot et al. (2019) conducted an RCT in Non-valvular atrial fibrillation (n=1,162). Educational program (information booklet, reminder tools, virtual clinic access) vs. Standard of care was evaluated on Implementation adherence of the dosing regimen (proportion of days adhering to the prescribed regimen) at 24 weeks (p=>0.7). An additional educational program did not significantly improve implementation adherence to apixaban at 24 weeks compared to standard of care (91.9% vs 91.6%) in patients with non-valvular atrial fibrillation.
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