Baseline characteristics of edoxaban treatment in routine clinical practice for patients with non-valvular atrial fibrillation in China (ETNA-AF-China)

Abstract

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Daiichi Sankyo (China) Holdings Co., Ltd, Shanghai, China. Background The effectiveness and safety of non-vitamin K antagonist oral anticoagulants (NOACs) edoxaban for the treatment of patients with non-valvular atrial fibrillation (NVAF) have been investigated globally. Data from mainland China, however, is scarce. Purpose To report baseline characteristics of unselected NVAF patients receiving edoxaban in routine clinical practice. Methods ETNA-AF-China is a multi-center, prospective, observational study designed to evaluate effectiveness and safety of edoxaban for stroke preventions in 89 sites across mainland China with 2-year follow-up. Enrollment started on February 2021 and ended on October 2022. Patients having history of NVAF, prescribed edoxaban, and providing written informed consent were eligible. This descriptive analysis of the baselines data is based on a snapshot from November 2022. Results A total of 5,000 patients were enrolled and data of 4749 patients with full edoxaban treatment information at baseline were analyzed (60 mg: 2559, 30 mg: 2190). Overall, mean (SD) patient age was 70.2 (9.55) years, with 1660 (35.0 %) patients ≥ 75 years. Male patients constituted 57.0 %. The average calculated creatinine clearance rate, CHA2DS2-VASc scores and HAS-BLED scores were 71.3 (27.8) mL/min, 2.88 (1.41) and 1.83 (1.04), respectively. Patients with perceived frailty, history of stroke, history of bleeding comprised 6.46 %, 8.78 %, 2.21% of the overall population, respectively (Table). The majority of patients (79.0 %) received recommended dose according to label criteria, with similar percentages observed among economic regions (East, 81.5 %; Northeast, 78.4 %; Middle, 76.0 %; West, 76.8 %). A numerically larger percentage of patients receiving non-recommended 30 mg were categorised as high risk for either stroke or bleeding (presence of prior stroke, prior major bleeding or prior ICH, or a CHA2DS2-VASc score ≥ 4; 34.1 % vs 25.6 %), frail assessed by physician (10.6 % vs 3.3 %), and had stage 3 chronic renal disease (58.8 % vs 39.4 %) compared with patients receiving recommended 60 mg. Those prescribed a non-recommended 60 mg vs those with recommended 30 mg were less likely to be considered stroke or bleeding high risk (40.2 % vs 46.8 %), and advanced renal disease (≥ stage 4, 10.7% vs 13.8 %) (Figure). Conclusion In this real-world study, edoxaban was predominantly prescribed with elder NVAF patients, on dose of 60 mg. Most of Chinese patients adhered to edoxaban approved label and the deviation from dose recommendation appears to be influenced by physician’s consideration of patient’s characteristics (such as stroke or bleeding high risk). More data profiles of ETNA-AF-China concerning effectiveness and safety study are collecting at the follow-up period.