Edoxaban for stroke prevention in atrial fibrillation in routine clinical care: 1-year follow-up of the prospective observational ETNA-AF-Europe study

Joris R de Groot, Thomas W Weiss, Peter Kelly, Pedro Monteiro, Jean Claude Deharo, Carlo de Asmundis, Esteban López-de-Sá, Johannes Waltenberger, Jan Steffel, Pierre Levy, Ameet Bakhai, Wolfgang Zierhut, Petra Laeis, Marius Constantin Manu, Paul-Egbert Reimitz, Raffaele De Caterina, Paulus Kirchhof

Research output: Contribution to journalArticlepeer-review

Abstract

AIMS: Non-vitamin K oral anticoagulants are safe and effective for stroke prevention in patients with atrial fibrillation (AF). Data on the safety and efficacy of edoxaban in routine care are limited in Europe. We report 1-year outcomes in patients with AF treated with edoxaban in routine care.

METHODS AND RESULTS: ETNA-AF-Europe is a prospective, multicentre, post-authorization, observational study enrolling patients treated with edoxaban in 10 European countries, the design of which was agreed with the European Medicines Agency as part of edoxaban's post-approval safety plan. Altogether 13 092 patients in 852 sites completed the 1-year follow-up [mean age: 73.6 ± 9.5 years; 57% male, mean follow-up: 352 ± 49 days (median: 366 days)]. Most patients had associated comorbidities (mean CHA2DS2-VASc score: 3.1 ± 1.4). Stroke or systemic embolism was reported in 103 patients (annualized event rate: 0.82%/year), and major bleeding events were reported in 132 patients (1.05%/year). Rates of intracranial haemorrhage were low [30 patients (0.24%/year)]. Death occurred in 442 patients (3.50%/year); cardiovascular (CV) death occurred in 206 patients (1.63%/year). The approved dosing of edoxaban was chosen in 83%. All-cause and CV mortality were higher in patients receiving edoxaban 30 mg vs. 60 mg, in line with the higher age and more frequent comorbidities of the 30 mg group. Major bleeding was also numerically more common in patients receiving edoxaban 30 mg vs. 60 mg.

CONCLUSION: The rates of stroke, systemic embolism, and major bleeding are low in this large unselected cohort of high-risk AF patients routinely treated with edoxaban.

Original languageEnglish
Pages (from-to)f30-f39
JournalEuropean heart journal. Cardiovascular pharmacotherapy
Volume7
Issue numberFI1
Early online date13 Aug 2020
DOIs
Publication statusPublished - 9 Apr 2021

Fingerprint

Dive into the research topics of 'Edoxaban for stroke prevention in atrial fibrillation in routine clinical care: 1-year follow-up of the prospective observational ETNA-AF-Europe study'. Together they form a unique fingerprint.

Cite this