Key result
Edoxaban treatment in patients with atrial fibrillation and a bioprosthetic aortic valve resulted in a complication rate of 2.08%, which was not significantly different from the 1.37% rate in the general atrial fibrillation control group (p=0.36).
Why the study?
Treatment with direct oral anticoagulants, particularly edoxaban, in patients with bioprosthetic aortic valves lacked consistent supporting data.
Does edoxaban safely and effectively prevent thromboembolic events in patients with atrial fibrillation and a bioprosthetic aortic valve compared to patients with non-valvular atrial fibrillation?
Cohort (n=36)
No
Does edoxaban safely and effectively prevent thromboembolic events in patients with atrial fibrillation and a bioprosthetic aortic valve compared to patients with non-valvular atrial fibrillation?
Absolute Event Rate: 2.08% vs 1.37%
p-value: p=0.36
Edoxaban appears safe and effective for stroke prevention in patients with atrial fibrillation and a bioprosthetic aortic valve, with overall event rates comparable to those with non-valvular atrial fibrillation.
Similar rates support edoxaban consideration in BPAV-AF; leaves open randomized confirmation of safety and efficacy.
Background: Nowadays the treatment with Direct Oral Anticoagulants (DOACs) and in particular with edoxaban in patients with Bioprosthetic Aortic Valve (BPAV) is unsupported by consistent data. We analyzed retrospectively our experience in this group of patients. Methods: The data of the present study were retrospectively obtained from 24 consecutive patients with BPVA evaluated for AF in a high-volume Italian cardiological center. We analyzed the data pulled from reports of patients with Nonvalvular Paroxymal Atrial Fibrillation (NVAF), that we entered in the Italian Registry of Drugs (AIFA registry). All patients were treated with edoxaban 60 mg for AF. At the time of the data collection, the average follow-up in valvular patients was 36 ± 3 months, with a median follow-up of 33 ± 6 months. Results: There were no major bleedings, strokes, systemic embolisms, or cardiovascular deaths reported. A single case of transitory ischemic event (6,25%) and a case of minor bleeding (6,25%) were reported during the follow-up. The complication rate was similar in patients with BPAV compared to that of the whole group of patients with fibrillation and there were no statistical differences (2.08% vs 1.37%; p: 0.36). Although the number is too small, transient ischemic attack appears to be more frequent in patients with BPAV than in the control group (p: 0.0046). Conclusion: In our experience, we used edoxaban in a group of 36 subjects with BPAV and AF: the event rate of this subpopulation was not different from that of all patients with AF included in the control group. Therefore, the results suggest that the use of edoxaban for AF in patients with BPVA appears to be safe and effective.
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Fazio et al. (2021) conducted a cohort in Atrial Fibrillation and Bioprosthetic Aortic Valve (n=36). Edoxaban vs. General atrial fibrillation patients treated with edoxaban was evaluated on Incidence of major bleedings, CRNMB thromboembolic events, ischemic or hemorrhagic stroke, systemic embolism, and cardiovascular death (p=0.36). Edoxaban treatment in patients with atrial fibrillation and a bioprosthetic aortic valve resulted in a complication rate of 2.08%, which was not significantly different from the 1.37% rate in the general atrial fibrillation control group (p=0.36).
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