Edoxaban Monotherapy and Incidence of Transcatheter Heart Valve Leaflet Thrombosis — The Rotterdam Edoxaban (REDOX) Study

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.BACKGROUNDTrials 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.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.AIMSThe 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.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.METHODSThe 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.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.RESULTSWe included 58 patients, of which 50 reached study completion including MSCT scanning and eight