Data Sheet 1_Edoxaban for stroke prevention in Chinese patients with atrial fibrillation: 1-year follow-up of the ETNA-AF-China study.docx

IntroductionNon–vitamin K antagonist oral anticoagulants (NOACs) are the first-line therapy to prevent ischaemic stroke in patients with atrial fibrillation (AF). However, studies on the effectiveness and safety of edoxaban for Chinese patients with AF, are limited.
MethodsWe report the 1-year interim follow-up data on edoxaban use in Chinese patients with AF from the ETNA-AF-China (NCT04747496), a multicentre, prospective, observational study conducted in 89 centres across the Chinese Mainland, enrolling 5,001 patients with a total of 2-year follow-up. No adjustment for multiple testing was made; therefore, all P values must be interpreted in an exploratory or descriptive manner.
ResultsOverall, 4,877 patients (60 mg edoxaban: 54.3%; 30 mg edoxaban: 45.7%) completed 1-year follow-up (mean age ± standard deviation: 70.3 ± 9.5 years; mean CHA2DS2-VASc score: 2.9 ± 1.4: mean HAS-BLED score: 1.8 ± 1.0). All-cause death occurred in 100 patients (annualised event rate: 2.30%/y), of whom 27 (0.62%/y) died from cardiovascular (CV) events. Annualised rates for major bleeding (45 patients [1.04%/y]), intracranial hemorrhage (ICH, nine patients [0.21%/y]), and major gastrointestinal bleeding (19 patients [0.44%/y]) were low. Patients receiving edoxaban 30 mg had numerically higher rates of all-cause death, CV death, and major bleeding than edoxaban 60 mg (P < 0.05), potentially because of diverse baseline characteristics. Lower BMI, permanent AF type, history of major bleeding, and frailty identified as risk factors of all-cause death by multivariable Cox analysis. After 1 year, 73.1% patients continued edoxaban use without suspension, discontinuation of edoxaban, or switching to other doses of edoxaban/other NOACs.
ConclusionIn a large Chinese AF population, edoxaban showed low incidences of stroke and bleeding, notably major bleeding, ICH, major gastrointestinal bleeding, and CV mortalities, with the majority of patients still on edoxaban at the end of 1-year follow-up.