Edoxaban Versus Dual Antiplatelet Therapy for Leaflet Thrombosis and Cerebral Thromboembolism After TAVR: The ADAPT-TAVR Randomized Clinical Trial
Key result
Edoxaban fails to reduce leaflet thrombosis compared to DAPT after TAVR.
- P=0.076
Why the study?
It was unknown whether edoxaban could reduce leaflet thrombosis and cerebral thromboembolic risk after TAVR, and whether subclinical leaflet thrombosis causes cerebral thromboembolism or neurocognitive dysfunction.
Population
Patients with successful TAVR without an indication for anticoagulation
Comparison
Edoxaban vs dual antiplatelet therapy (aspirin plus clopidogrel)
Design
Multicenter open-label randomized trial
Follow-up
6 months
Authors
Discussion
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Member takes
Implication
Should not yet change antithrombotic practice after TAVR; leaves open whether reducing leaflet thrombosis improves cerebral outcomes.
Key Points
- To determine whether edoxaban reduces leaflet thrombosis and associated cerebral thromboembolic risk compared with dual antiplatelet therapy following transcatheter aortic valve replacement.
- Multicenter, open-label randomized trial (NCT03284827) comparing edoxaban versus dual antiplatelet therapy (aspirin plus clopidogrel) in patients after successful transcatheter aortic valve replacement without indication for long-term anticoagulation.
- Evaluated leaflet thrombosis incidence at 6 months as the primary endpoint using 4-dimensional computed tomography.
- Assessed key secondary outcomes including new cerebral lesion count and volume on brain magnetic resonance imaging, neurocognitive and neurological function changes, and bleeding events.
- Leaflet thrombosis incidence was numerically lower with edoxaban compared with dual antiplatelet therapy, but the difference did not achieve statistical significance (P=0.076).
- New cerebral lesions on magnetic resonance imaging occurred in 25.0% of patients receiving edoxaban versus 20.2% receiving dual antiplatelet therapy (difference, 4.8%; 95% CI, -6.4% to 16.0%), with no differences in total lesion count or volume.
- Rates of neurocognitive deterioration and any or major bleeding events did not differ significantly between arms, and leaflet thrombosis was not significantly associated with new cerebral lesions.
Study Design
Type
RCT
Blinding
Open-label
Multicenter
Yes
PICO
P
Population
Patients without an indication for anticoagulation who underwent successful transcatheter aortic valve replacement, evaluated at 6 months.
I
Intervention / Comparator
Edoxaban vs Dual antiplatelet therapy (aspirin plus clopidogrel)
O
Primary Outcome
Incidence of leaflet thrombosis on 4-dimensional computed tomography at 6 months, p==0.076
Main Result
p-value: p==0.076
Limitations
- The study was underpowered
Cite This Study
Park et al. (2022) conducted an RCT in Leaflet Thrombosis and Cerebral Thromboembolism After TAVR. Edoxaban vs. Dual antiplatelet therapy (aspirin plus clopidogrel) was evaluated on Incidence of leaflet thrombosis on 4-dimensional computed tomography at 6 months (p==0.076). Edoxaban did not significantly reduce the incidence of leaflet thrombosis at 6 months compared to dual antiplatelet therapy in patients post-TAVR without an indication for anticoagulation (P=0.076).