Periprocedural Edoxaban Management and Clinical Outcomes in Patients Undergoing Transcatheter Cardiovascular Procedures in the EMIT-AF/VTE Program

Abstract

Annually, 10% of patients with atrial fibrillation (AF) or venous thromboembolism (VTE) treated with non-vitamin K oral anticoagulants undergo diagnostic or therapeutic procedures. This subanalysis of the multicenter, prospective, observational Edoxaban Management in Diagnostic and Therapeutic Procedures real-world registry included patients in Europe and Asia with AF or VTE who underwent transcatheter cardiovascular (CV) procedures. Edoxaban interruption and clinical outcomes were assessed for all arterial or venous access procedures and stratified by bleeding risk. Overall, 2695 procedures were reported; 755 (28.0%) were transcatheter CV procedures, of which 373 (49.4%) were arterial access and 382 (50.6%) were venous access procedures. Patients with arterial versus venous access procedures had significantly higher bleeding and stroke and thromboembolism risk scores ( P < 0.0001 for both) and underwent procedures that were more frequently classified as having a higher European Heart Rhythm Association bleeding risk. Edoxaban was interrupted in 59.5% (222) arterial versus 42.4% (162) venous access procedures, mostly either only preprocedurally or both pre- and postprocedurally. The combined incidence of clinically relevant ischemic or bleeding event rates and deaths was low (0.8 events/100 procedures). This subanalysis showed that while edoxaban was interrupted in approximately half of all interventions, ischemic events and major bleeding were low, suggesting transcatheter CV procedures can be performed safely in high-risk patients with AF or VTE. Patient and procedural factors should be considered to personalize the decision of edoxaban management around the time of a transcatheter CV procedure. Clinical trial registration number: NCT02950168, NCT02951039