ADAPT-TAVR
Trial question
Is edoxaban superior to dual antiplatelet therapy in patients who had undergone successful TAVR?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
58.0% female
42.0% male
N = 229
229 patients (133 female, 96 male)
Inclusion criteria: adult patients without an indication for long-term anticoagulation who had undergone successful TAVR for severe aortic stenosis
Key exclusion criteria: indication for anticoagulation; absolute indication for dual antiplatelet therapy; severe renal insufficiency prohibiting CT imaging
Interventions
N=111 edoxaban (30-60 mg once daily for 6 months)
N=118 dual antiplatelet therapy (aspirin at 100 mg once daily plus clopidogrel at 75 mg once daily for 6 months)
Primary outcome
Leaflet thrombosis at 6 months
9.8
18.4
18.4 %
13.8 %
9.2 %
4.6 %
0.0 %
Edoxaban
Dual antiplatelet therapy
No significant difference ↔
No significant difference in leaflet thrombosis at 6 months (9.8% vs. 18.4%; ARD -8.5, 95% CI -17.8 to 0.8)
Secondary outcomes
No significant difference in patients with new cerebral lesions (25% vs. 20.2%; AD 4.8%, 95% CI -6.4 to 16)
No significant difference in patients with worsening of serial neurological testing (5% vs. 3.7%; AD 1.3%, 95% CI -4.3 to 6.9)
No significant difference in patients with worsening of neurocognitive function (30% vs. 22.2%; AD 7.8%, 95% CI -4.2 to 19.7)
Safety outcomes
No significant difference in any or major bleeding events.
Conclusion
In adult patients without an indication for long-term anticoagulation who had undergone successful TAVR for severe aortic stenosis, edoxaban was not superior to dual antiplatelet therapy with respect to leaflet thrombosis at 6 months.
Reference
Duk-Woo Park, Jung-Min Ahn, Do-Yoon Kang et al. Edoxaban versus Dual Antiplatelet Therapy for Leaflet Thrombosis and Cerebral Thromboembolism after TAVR: The ADAPT-TAVR Randomized Clinical Trial. Circulation. 2022 Aug 9;146(6):466-479.
Open reference URL