MUNICH, March 19, 2019 /PRNewswire/ --
-- In 2019, the Edoxaban Clinical Research Programme will deliver new evidence on LIXIANA()? (edoxaban) use in clinical practice. EMIT-AF/VTE is one of the first sets of data to be presented -- EMIT-AF/VTE is a large observational, multicentre, multinational study on edoxaban peri-procedural management and outcomes -- It is the first large prospective, non-interventional study to apply the European Heart Rhythm Association (EHRA) bleeding risk classification in edoxaban routine clinical practice(1) -- In EMIT-AF/VTE, peri-procedure use of oral, once-daily edoxaban was associated with low incidence of bleeding and thromboembolic events, in elderly European Atrial Fibrillation (AF) and Venous Thromboembolism (VTE) patients
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, 19 Mar. (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.
About EMIT-AF/VTEThe observational study, conducted across seven European countries, includes data from 1,155 first diagnostic/therapeutic procedures in unselected edoxaban patients with AF and VTE. EMIT-AF/VTE is a multinational, multicentre, prospective observational, non-interventional study.(4) The primary safety outcome was the incidence of major bleeding from five days before to 30 days post-procedure. Secondary objectives include efficacy outcomes as a composite of major cardiovascular events and collecting details on the types of diagnostic or therapeutic procedures.(2)
About Atrial FibrillationAF is a condition where the heart beats irregularly and rapidly. When this happens, blood can pool and thicken in the chambers of the heart causing an increased risk of blood clots. These blood clots can break off and travel through the blood stream to the brain (or sometimes to another part of the body), where they have the potential to cause a stroke.(5)
AF is the most common type of heart rhythm disorder and is associated with substantial morbidity and mortality.(6) More than six million Europeans are diagnosed with AF, and this figure is expected to at least double over the next 50 years.(7,8 )Compared to those without AF, people with the arrhythmia have a 3-5 times higher risk of stroke.(9) One in five of all strokes are as a result of AF.(7)
About Venous Thromboembolism VTE is an umbrella term for two conditions, DVT and PE. DVT is a disease caused by a blood clot found in deep veins, usually within the lower leg, thigh or pelvis, although they can occur in other parts of the body as well.(10) PE occurs when part of a clot detaches and lodges in the pulmonary arteries, causing a potentially fatal condition.(11)
VTE is a major cause of morbidity and mortality.(12) There is a high rate of recurrence after a first VTE event, which is reduced with anticoagulant treatment. Without anticoagulant treatment, approximately half of patients who experience an initial VTE event have recurrent VTE within three months.(13 )
About EdoxabanEdoxaban is an oral, once-daily, direct factor Xa (pronounced "Ten A") inhibitor. Factor Xa is one of the key components responsible for blood clotting, so inhibiting this makes the blood thin and less prone to clotting. Edoxaban is currently marketed by Daiichi Sankyo and its partners in more than 20 countries around the world.
About Edoxaban Clinical Research Programme
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