ETNA-AF-Europe (Clinicaltrials.gov: NCT02944019) is a multinational, multicentre, post-authorization, observational study conducted in 852 sites in 10 European countries (Austria, Belgium, Germany, Ireland, Italy, The Netherlands, Portugal, Spain, Switzerland, and UK). ETNA-AF-Europe is part of the global ETNA initiative, which is composed of separate, non-interventional prospective ETNA-AF registries in Europe, East Asia, and Japan. The design of the ETNA-AF-Europe was agreed in close collaboration with the European Medicines Agency (EMA) and has been previously published.13 (link),14 (link) The study was approved by the institutional review boards and independent Ethics Committees for all participating centres in compliance with the Declaration of Helsinki and Guidelines for Good Pharmacoepidemiological Practice (GPP). All participants provided written informed consent.
Unselected routine patients with AF treated with edoxaban, providing consent, were prospectively enrolled. Explicit exclusion criteria were not defined. The primary objective of ETNA-AF-Europe is to assess the routine clinical care safety of edoxaban by evaluating bleeding events, including ICH; drug-related adverse events; and cardiovascular (CV) and all-cause mortality in routine care patients with AF treated with edoxaban up to 4 years, with regard to onset (relative to treatment with edoxaban), duration, severity and outcomes of the events. Details of the inclusion criteria and secondary objectives can be found in the ETNA-AF-Europe design paper.13 (link) Here, we present 1-year follow-up outcomes of the first 13 092 patients as captured on 31 October 2019.
Besides description of patients’ characteristics and outcomes, event rates are compared descriptively with event rates reported amongst non-Asian patients included in the Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48 (ENGAGE AF-TIMI 48) study. In ETNA-AF-Europe, all patients were included, including a minority of Asians living in Europe. From ENGAGE AF-TIMI 48, ‘non-Asian’ self-designated patients were used to contextualize against ETNA-AF-Europe data, in view of a sub-analysis that has confirmed a preferential efficacy with edoxaban in Asian vs. non-Asian patients.15 (link) Therefore, the side-by-side presentation of ETNA-AF-Europe and ENGAGE AF-TIMI 48 in this paper is intended to be a conservative exercise.
Unselected routine patients with AF treated with edoxaban, providing consent, were prospectively enrolled. Explicit exclusion criteria were not defined. The primary objective of ETNA-AF-Europe is to assess the routine clinical care safety of edoxaban by evaluating bleeding events, including ICH; drug-related adverse events; and cardiovascular (CV) and all-cause mortality in routine care patients with AF treated with edoxaban up to 4 years, with regard to onset (relative to treatment with edoxaban), duration, severity and outcomes of the events. Details of the inclusion criteria and secondary objectives can be found in the ETNA-AF-Europe design paper.13 (link) Here, we present 1-year follow-up outcomes of the first 13 092 patients as captured on 31 October 2019.
Besides description of patients’ characteristics and outcomes, event rates are compared descriptively with event rates reported amongst non-Asian patients included in the Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48 (ENGAGE AF-TIMI 48) study. In ETNA-AF-Europe, all patients were included, including a minority of Asians living in Europe. From ENGAGE AF-TIMI 48, ‘non-Asian’ self-designated patients were used to contextualize against ETNA-AF-Europe data, in view of a sub-analysis that has confirmed a preferential efficacy with edoxaban in Asian vs. non-Asian patients.15 (link) Therefore, the side-by-side presentation of ETNA-AF-Europe and ENGAGE AF-TIMI 48 in this paper is intended to be a conservative exercise.
