Edoxaban for stroke prevention in atrial fibrillation in routine clinical care

TY - JOUR

T1 - Edoxaban for stroke prevention in atrial fibrillation in routine clinical care

T2 - 1-year follow-up of the prospective observational ETNA-AF-Europe study

AU - de Groot, Joris R

AU - Weiss, Thomas W

AU - Kelly, Peter

AU - Monteiro, Pedro

AU - Deharo, Jean Claude

AU - de Asmundis, Carlo

AU - López-de-Sá, Esteban

AU - Waltenberger, Johannes

AU - Steffel, Jan

AU - Levy, Pierre

AU - Bakhai, Ameet

AU - Zierhut, Wolfgang

AU - Laeis, Petra

AU - Manu, Marius Constantin

AU - Reimitz, Paul-Egbert

AU - De Caterina, Raffaele

AU - Kirchhof, Paulus

AU - ETNA-AF-Europe investigators

N1 - © The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology.

PY - 2021/4/9

Y1 - 2021/4/9

N2 - 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.

AB - 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.

U2 - 10.1093/ehjcvp/pvaa079

DO - 10.1093/ehjcvp/pvaa079

M3 - SCORING: Journal article

C2 - 32790837

VL - 7

SP - f30-f39

JO - EUR HEART J-CARD PHA

JF - EUR HEART J-CARD PHA

SN - 2055-6837

IS - FI1

ER -