The first patient has been enrolled in Daiichi Sankyo’s EMIT-AF/VTE (Edoxaban Management in Diagnostic and Therapeutic Procedures) study. This registry will collect real-world clinical data on the use of once-daily edoxaban (Lixiana) with regard to diagnostic and interventional procedures in patients with non-valvular atrial fibrillation (NVAF) or venous thromboembolism.
Limited information is currently available regarding the use of edoxaban in patients undergoing medical procedures. Patients who are treated with non-vitamin K antagonist oral anticoagulants (NOACs), such as edoxaban, undergo diagnostic and therapeutic procedures at a rate of 10% a year, and if the surgical interventions carry a bleeding risk, NOAC treatment must be temporarily discontinued. The EMIT-AF/VTE study will provide further insight into the use of edoxaban in patients undergoing diagnostic and therapeutic procedures.
Patients will be enrolled from primary and secondary care settings, as well as other specialty settings. The primary objective of the study is to document the peri-procedural management of edoxaban and collect data on safety and other outcomes in these patients. The primary safety outcome is the rate of major bleeding (within 30 days post intervention) using the ISTH definition.
Juan-Carlos Jaramillo, head of Market Access and Medical Affairs at Daiichi Sankyo Europe, says “This registry will provide important information that expands our knowledge on the use of edoxaban and will ensure healthcare professionals are equipped to achieve the best possible outcomes for NVAF and VTE patients undergoing medical procedures.”
The EMIT-AF/VTE registry will comprise approximately 2,000 patients over the next two and a half years. Data will be collected from patients treated with edoxaban for 2,000 planned or unplanned procedures across 500 sites, including hospitals and office-based sites, in Belgium, France, Germany, Italy, The Netherlands, Spain, and the UK. Daiichi Sankyo is also reviewing options to expand the EMIT-AF/VTE registry to clinical sites beyond Europe.