Daiichi Sankyo Europe GmbH (hereafter, "Daiichi Sankyo") announced today the results from EMIT-AF/VTE, a prospective, non-interventional study of oral, once-daily edoxaban (known by the brand name LIXIANA) in the peri-procedural management of AF, and 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.2 The data were presented today during a late-breaker session at EHRA 2019, the annual congress of the European Heart Rhythm Association, in Lisbon, Portugal.
EMIT-AF/VTE is the first large observational, multicentre, multinational study on peri-procedural management and outcomes of edoxaban. It is the first large, single NOAC-prospective, non-interventional study to apply the EHRA peri-procedural bleeding risk classification, which was introduced in April 2018,1 in a routine clinical practice setting.
Patients enrolled onto EMIT-AF/VTE were 62% male, elderly (mean age = 71.9 10.4 years, 45% 75 years of age) and had multiple co-morbidities.2 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.2
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).2
Commenting on the data, Paolo Colonna, MD, Professor of Cardiology at University Hospital and Policlinico of Bari, Italy, said, "Until now, there has been limited data available on the peri-procedural management of patients prescribed a NOAC, such as edoxaban, and the associated clinical outcomes. The low rates of bleeding and thromboembolic/ischemic complications associated with edoxaban in the EMIT-AF/VTE study provides insights of edoxaban use in unselected patients undergoing diagnostic or therapeutic procedures."
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.3 Thrombotic/ischemic events occurred in 0.6% (7 of 1,155) of patients.2
"The EMIT-AF/VTE study is part of the Edoxaban Clinical Research Programme that, in 2019, will deliver significant evidence to support the use of edoxaban in clinical practice, particularly for elderly patients. The results of this study further support Daiichi Sankyo Europe`s long-term commitment to cardiovascular care", said Wolfgang Zierhut, MD, Executive Director Medical Affairs and Head Thrombosis and Cardiovascular at Daiichi Sankyo Europe.
EMIT-AF/VTE is one of several studies included within the programme. More than 100,000 patients worldwide are expected to participate in studies, the goal of which is to generate new clinical and real-world data regarding the use of edoxaban in AF and VTE populations, thus, providing physicians and patients worldwide with greater treatment assurance.
(c) 2019 TehranTimes. All Rights Reserved. Provided by SyndiGate Media Inc. (Syndigate.info)., source Middle East & North African Newspapers