Key result
Post-TAVI edoxaban monotherapy yields a ~12% incidence of leaflet thickening at 3 months.
Why the study?
NOACs reduced subclinical leaflet thrombosis versus antiplatelet-based strategies but increased mortality and major bleeding, often combined with antiplatelet therapy.
Cohort (n=58)
Open-label
No
Edoxaban monotherapy for 3 months following TAVI was associated with a 12.0% incidence of subclinical leaflet thrombosis and a favorable safety profile with low clinical event rates in patients without an indication for long-term oral anticoagulation.
Edoxaban monotherapy after TAVI merits prospective evaluation; leaves open its role versus standard regimens in patients without anticoagulation indications.
BACKGROUND: Trials comparing non-vitamin K oral anticoagulant (NOAC) versus antiplatelet-based strategies have shown a reduction of subclinical leaflet thrombosis at the cost of increased mortality and major-bleedings. NOACs were often combined with antiplatelet therapy. AIMS: The Rotterdam Edoxaban (REDOX) study aimed to evaluate the impact of edoxaban monotherapy on the incidence of hypo-attenuated leaflet thickening (HALT) and reduced leaflet motion (RLM) and to evaluate safety in terms of mortality, thromboembolic events and major bleeding. METHODS: The REDOX study is a single-arm, open-label trial including patients after successful transcatheter aortic valve implantation (TAVI) with no formal indication for oral anticoagulation or dual antiplatelet therapy. Patients received edoxaban monotherapy for 3 months, followed by multislice computed tomography (MSCT). The primary endpoint was the occurrence of HALT. Clinical follow-up continued up to 1 year after TAVI. RESULTS: We included 58 patients, of which 50 reached study completion including MSCT scanning and eight withdrew consent before end of study. At 3-months follow-up, HALT of any grade was detected in 12.0% (95% confidence interval (CI): 5.0%-23.1%) of patients. HALT grade ≥ 3 occurred in 4.0% (95% CI: 0.8%-12.2%) of patients. At 1 year follow-up, all patients were alive and free of disabling strokes. Three patients had a non-disabling stroke and one patient had a major bleeding. CONCLUSIONS: In the REDOX study, edoxaban monotherapy after TAVI was associated with a 12.0% incidence of any HALT and a 4.0% incidence of HALT grade ≥ 3. HALT was not associated with clinical events.
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Adrichem et al. (2024) conducted a cohort in Severe aortic stenosis post-TAVI without formal indication for oral anticoagulation (n=58). Edoxaban was evaluated on Occurrence of any hypo-attenuated leaflet thickening (HALT) in ≥ 1 leaflet at 3 months after TAVI (95% CI 5.0%-23.1%). Edoxaban monotherapy after TAVI was associated with a 12.0% incidence of any HALT and a 4.0% incidence of HALT grade ≥ 3 at 3 months follow-up.
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