ETNA-AF-Europe Registry Data on LIXIANA®▼(edoxaban) Published in a Leading Cardiology Journal Highlights Important Clinical Considerations for Treating Ageing Patients with Atrial Fibrillation

• Publication highlights Europe-specific one-year follow-up findings for atrial fibrillation (AF) patients in routine clinical practice, in which, rates of stroke, systemic embolism, and major bleeding are considered by the authors to be low in edoxaban treated patients¹
• Findings are part of growing scientific evidence reinforcing the safety and effectiveness of edoxaban in routine care in Europe

• The global ETNA-AF programme, which includes ETNA-AF-Europe, is a Post-Authorisation Safety Study (PASS) and is the largest prospective, non-interventional study investigating a single direct oral anticoagulant (DOAC) to date

Munich, Germany (20 August 2020) – Daiichi Sankyo Europe GmbH (hereafter, “Daiichi Sankyo”) today announced the publication of one-year follow up results from the ongoing ETNA-AF-Europe (Edoxaban Treatment in routiNe clinical prActice for patients with non-valvular Atrial Fibrillation) registry in the European Heart Journal - Cardiovascular Pharmacotherapy.¹

Published data highlights Europe-specific, routine clinical practice findings, in which, the rates of stroke, systemic embolism, and major bleeding are considered by the authors to be low in a large unselected cohort of AF patients being treated with edoxaban.¹

ETNA-AF Europe is a multinational, multicentre, post-authorisation, observational study of 13,092 patients across Europe, and is part of the largest prospective, non-interventional study programme investigating a single DOAC in patients with non-valvular atrial fibrillation (NVAF) to date.¹

While DOAC use in clinical practice is increasingly becoming the standard of care with several registries and retrospective analyses having assessed outcomes of three of the four available DOACs, prior to ETNA-AF, edoxaban data had been more limited.¹

“Findings noted in ETNA-AF-Europe now complement the outcomes reported in other observational data sets on DOACs. The strengths of the study include a large sample size, a four-year duration, a prospective study design, an international setting including 10 countries, and the lack of explicit exclusion criteria. The low rates of stroke, major bleeding, and death illustrate that anticoagulation with edoxaban, similar to other DOACs, is an effective tool to reduce serious outcomes in patients with atrial fibrillation,” said study author, Professor Paulus Kirchhof, MD, Director of the Department of Cardiology, University Heart and Vascular Centre UKE Hamburg, Germany, and Professor of Cardiovascular Medicine, Institute of Cardiovascular Sciences at University of Birmingham, UK.

Advancing age, accumulation of comorbidities and frailty are believed to increase thromboembolic and bleeding risks in patients with AF. According to the authors’ assessment, the one-year follow-up ETNA-AF-Europe dataset demonstrates a low and constant rate of intracranial haemorrhage (ICH) in both ageing and younger patients with AF.¹

The overall rates of major bleeding, stroke, and systemic embolism, as well as all-cause mortality, were considered by the authors to be low and linearly increasing during the one-year follow-up:¹

• Major bleeding events were reported in 132 patients (1.05%/year), of which 51 (0.4%/year) were gastro-intestinal and 30 (0.2%/year) were ICH.
• Stroke or systemic embolism occurred in 103 patients (0.82%/year).
• In total, 442 patients died (3.5%/year), of whom 206 patients (1.63%/year) died of cardiovascular causes.

Findings observed in ETNA-AF-Europe were in line with those reported for a cohort of patients of the ENGAGE AF-TIMI 48 study, who did not self-identify as Asians.²

Notably, the permanent discontinuation rate at one year was considered by the authors to be relatively low (9.1%) compared with a similar PASS registry with a different DOAC, which reported a discontinuation rate of 20.1% at one year.^1,3 The wider global ETNA-AF programme has so far collected data from 24,962 patients in 2,242 sites in Japan, Korea/Taiwan and Europe. The study is part of the Edoxaban Clinical Research Programme, which includes more than 10 randomised, controlled trials, registries and non-randomised clinical studies.