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2 results on '"on behalf of the ETNA-AF-Europe investigators"'

1. Characteristics of patients initiated on edoxaban in Europe: baseline data from edoxaban treatment in routine clinical practice for patients with atrial fibrillation (AF) in Europe (ETNA-AF-Europe)

Author

Raffaele De Caterina, Peter Kelly, Pedro Monteiro, Jean Claude Deharo, Carlo de Asmundis, Esteban López-de-Sá, Thomas W. Weiss, Johannes Waltenberger, Jan Steffel, Joris R. de Groot, Pierre Levy, Ameet Bakhai, Wolfgang Zierhut, Petra Laeis, Michael Kerschnitzki, Paul-Egbert Reimitz, Paulus Kirchhof, and on behalf of the ETNA-AF-Europe investigators

Subjects
Non-vitamin K antagonist oral anticoagulants, Real-world, Registry, Stroke prevention, Major bleeding, Safety outcomes, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Abstract Background Non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) have substantially improved anticoagulation therapy for prevention of stroke and systemic embolism in patients with atrial fibrillation (AF). The available routine care data have demonstrated the safety of different NOACs; however, such data for edoxaban are scarce. Here, we report baseline characteristics of 13,638 edoxaban-treated patients with AF enrolled between November 2016 and February 2018. Methods ETNA-AF-Europe is a multinational, multi-centre, post-authorisation, observational study conducted in 825 sites in 10 European countries. Patients will be followed up for four years. Results Overall, 13,980 patients were enrolled of which 342 patients were excluded from the analysis. Mean patient age was 73.6 years with an average creatinine clearance of 69.4 mL/min. 56.6% were male. The calculated CHA2DS2-VASc and HAS-BLED mean scores were 3.1 and 2.6, respectively. Overall, 3.3, 14.6 and 82.0% of patients had low (CHA2DS2-VASc = 0), intermediate (CHA2DS2-VASc = 1) and high (CHA2DS2-VASc≥2) risks of stroke, respectively. High-risk patients (those with prior stroke, prior major bleeding, prior intracranial bleed or CHA2DS2-VASc ≥4) comprised 38.4% of the overall population. For 75.1% of patients edoxaban was their first anticoagulant prescription, whilst 16.9% switched from a VKA and 8.0% from another NOAC. A total of 23.4% of patients in ETNA-AF-Europe received the reduced dose of edoxaban 30 mg. Overall, 83.8% of patients received an edoxaban dose in line with the criteria outlined in the label. Conclusion Edoxaban was predominantly initiated in older, often anticoagulation-naïve, unselected European patients with AF, with a good overall adherence to the approved label. Trial registration NCT02944019; Date of registration: October 24, 2016.

Published
2019
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2. Design and rationale of the Edoxaban Treatment in routiNe clinical prActice for patients with Atrial Fibrillation in Europe (ETNA-AF-Europe) study

Author

De Caterina, R., Kelly, P., Monteiro, P., Deharo, J. C., de Asmundis, C., López-de-Sá, E., Weiss, T. W., Waltenberger, J., Steffel, J., de Groot, J. R., Levy, P., Bakhai, A., Zierhut, W., Laeis, P., Reimitz, P. -E., Kirchhof, P., on behalf of the ETNA-AF-Europe investigators, Clinical sciences, Heartrhythmmanagement, Institute of Clinical Physiology, National Council of Research, NS Research, Novartis Institutes for BioMedical Research (NIBR), Division of Medicine, University College of London [London] (UCL), Neurovascular Clinical Science Unit, Catherine McAuley Centre, Mater Misericordiae University Hospital, Département de Cardiologie [Hôpital de la Timone - APHM], Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Laboratoire d'Economie de Dauphine (LEDa), Université Paris Dauphine-PSL, Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL), Laboratoire d'Economie et de Gestion des Organisations de Santé (Legos), Department of Medicine, Royal Free (DEPARTMENT OF MEDICINE, ROYAL FREE), Royal Free and University College London School of Medicine, Daiichi Sankyo Inc., Daiichi Sankyo Co., ACS - Heart failure & arrhythmias, Cardiology, University of Zurich, and De Caterina, Raffaele

Subjects
Research design, Time Factors, medicine.drug_mechanism_of_action, Pyridines, Administration, Oral, Major bleeding, 030204 cardiovascular system & hematology, chemistry.chemical_compound, 0302 clinical medicine, Edoxaban, Stroke prevention, Atrial Fibrillation, Epidemiology, Routine clinical practice, Prospective Studies, Registries, 030212 general & internal medicine, Prospective cohort study, Stroke, [QFIN]Quantitative Finance [q-fin], Atrial fibrillation, General Medicine, 3. Good health, Europe, JEL: I - Health, Education, and Welfare/I.I1 - Health/I.I1.I11 - Analysis of Health Care Markets, Treatment Outcome, ETNA-AF-Europe study, Research Design, 10209 Clinic for Cardiology, epidemiology, Cardiology and Cardiovascular Medicine, Registry, medicine.medical_specialty, Factor Xa Inhibitor, 610 Medicine & health, Hemorrhage, 2705 Cardiology and Cardiovascular Medicine, 03 medical and health sciences, Nonvitamin K antagonist oral anticoagulants, Internal medicine, medicine, Humans, cardiovascular diseases, Safety outcomes, business.industry, PREFER in AF, medicine.disease, JEL: I - Health, Education, and Welfare/I.I1 - Health/I.I1.I12 - Health Behavior, Thiazoles, Real-world, chemistry, business, Factor Xa Inhibitors
Abstract

AIM: Edoxaban, a nonvitamin K antagonist oral anticoagulant, is an oral factor Xa inhibitor approved for the prevention of stroke and systemic embolism in adult patients with atrial fibrillation and for the treatment and secondary prevention in adult patients with venous thromboembolism (VTE). This study details the design of the Edoxaban Treatment in routiNe clinical prActice for patients with Atrial Fibrillation in Europe (ETNA-AF-Europe) study - a postauthorization observational study, which is part of the postapproval plan for edoxaban agreed with the European Medicines Agency. METHODS: The ETNA-AF-Europe study (Clinicaltrials.gov: NCT02944019) is a multicenter, prospective, observational study that enrolled 13 980 patients with atrial fibrillation treated with edoxaban from 852 sites across 10 European countries (Austria, Belgium, Germany, Ireland, Italy, the Netherlands, Portugal, Spain, Switzerland, and the United Kingdom). Patients treated with edoxaban were prospectively enrolled and will be followed up for 4 years with yearly follow-up visits. ASSESSMENTS: The primary objective of the ETNA-AF-Europe study is to assess the real-world safety of edoxaban by evaluating bleeding events, including intracranial hemorrhage; drug-related adverse events, such as hepatic events; and cardiovascular and all-cause mortality. In addition, efficacy will be assessed by recording major adverse cardiovascular events including stroke, systemic embolic events, transient ischemic attacks, and also VTE episodes, acute coronary syndromes, and hospitalizations related to cardiovascular condition. Event rates will be compared with event rates reported in the PREvention oF thromboembolic events-European Registry in Atrial Fibrillation in atrial fibrillation (PREFER in AF) and PREFER in AF Prolongation registries, and in the Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation - Thrombolysis in Myocardial Infarction 48 study datasets.

Published
2019
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