EMIT-AF/VTE study of Lixiana finds low bleeding rates in patients at risk of stroke and VTE

Daiichi Sankyo announced the results from EMIT-AF/VTE, a prospective, non-interventional study of oral, once-daily Lixiana (edoxaban) in the peri-procedural management of atrial fibrillation (AF), and Venous Thromboembolism (VTE) patients undergoing diagnostic and therapeutic procedures. The data from 1,155 patients across seven European countries showed that peri-procedural edoxaban management in routine clinical practice was associated with low bleeding incidence, even in procedures at high bleeding-risk as classified by EHRA, and with low rates of thromboembolic/ischemic complications.

Patients enrolled onto EMIT-AF/VTE were 62% male, elderly (mean age = 71.9 +/- 10.4 years, 45% at least 75 years of age) and had multiple co-morbidities. Of the participants, 294 (26%) had minor EHRA bleeding risk, 581 (50%) had low-risk, and 280 (24%) had high-risk. Additionally, 30% (345/1,155) of patients continued edoxaban treatment without any interruption during the peri-procedural period, whereas 73% (847/1,155) of patients were on edoxaban on the day after procedure with no post-procedural interruption. The primary safety outcome of major bleeding (MB), as defined by the International Society of Thrombosis and Haemostasis (ISTH), from five days before to 30 days after a procedure, occurred in 0.4% (5 of 1,155) of patients. Bleeding incidence was low, even in the 280 EHRA-classified high-risk procedures: with 0.7% (2 of 280) major bleedings and 1.4% (4 of 280) clinically relevant non-major bleedings (CRNMB).

The secondary objective was to document the incidence of the composite of acute coronary syndrome (ACS), non-hemorrhagic stroke, transient ischemic attack (TIA), systemic embolism (SEE), deep vein thrombosis (DVT), pulmonary embolism (PE) and cardiovascular (CV) death. Thrombotic/ischemic events occurred in 0.6% (7 of 1,155) of patients. The data were presented during a late-breaker session at EHRA 2019.