6/28/23, 12:02 AM ADAPT-TAVR Pathway Feedback Search Clinical Topics Home Studies ADAPT TAVR ADAPT TAVR Disease Aortic stenosis 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 N = 229 42.0% male 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 https://web.pathway.md/studies/recmIQwExQWFk9IIz 1/2 6/28/23, 12:02 AM ADAPT-TAVR Pathway Leaflet thrombosis at 6 months 18.4 % 18.4 13.8 % 9.8 9.2 % 4.6 % No significant difference 0.0 % Edoxaban Dual antiplatelet therapy 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 the percentage of patients with new cerebral lesions (25% vs. 20.2%; AD 4.8%, 95% CI -6.4 to 16) No significant difference in the percentage of 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 the percentage of 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 https://web.pathway.md/studies/recmIQwExQWFk9IIz 2/2