Aim: As the non-vitamin K antagonist oral anticoagulant (NOAC) most recently approved in China, data pertaining to clinical edoxaban use are still scarce. This study investigated the prevalence of and contemporary trends in edoxaban prescription among Chinese patients as well as factors associated with its inappropriate use in a multi-center registry of patients treated in real-world clinical practice. Methods: This real-world, prospective, multicenter, and non-interventional study included 1005 inpatients treated with edoxaban. According to National Medical Products Administration and European Heart Rhythm Association guidelines, edoxaban therapy was determined to be appropriate or inappropriate in each case. Results: The median patient age was 70.0 years (interquartile range, 61.0–78.0 years), and 46.3% were women. Overall, 456 (45.4%) patients received inappropriate edoxaban therapy, and common issues included an inappropriately low (183, 18.2%) or high (73, 7.3%) dosage, wrong drug selection (109, 10.8%), unreasonable off-label use (49, 4.9%), incorrect administration timing (16, 1.6%), and contraindication due to other medications (27, 2.7%). Several factors (e.g., age, weight, kidney function, anemia, and bleeding history) were associated with an increased risk of inappropriate edoxaban therapy, whereas factors associated with cardiovascular specialties (e.g., hospitalized in cardiovascular department and dronedarone or amiodarone use) decreased this risk. Conclusion: In this real-world study, 45.4% of patients received an inappropriate treatment with edoxaban. Multiple clinical characteristics can help identify patients who should receive edoxaban. Further development and implantation of educational activities and management strategies are needed to ensure the correct use of edoxaban.

Aim The population included in randomized controlled clinical trial of ROCKET AF and observational studies were different, and the effectiveness and safety of rivaroxaban in stroke prevention of atrial fibrillation (AF) varied among studies. The aim of this study was to estimate the real-world outcomes of rivaroxaban in AF patients in a relatively accurate way. Methods A discrete event simulation (DES) model was proposed to predict the counterfactual outcomes of ROCKET AF that would have it been conducted in broader observational study populations. The hypothetical cohorts of patients were generated using Monte Carlo simulation. The DES model structure was built based on disease progression and possible outcomes of AF. Cardiovascular events were recorded during the simulated two-year follow-up period. Results The results showed lower predicted rates of stroke/ systemic embolism (SE) and major bleeding in three observational studies than those in simulated ROCKET AF. The simulated stroke/SE incidence was 1.097-1.318 per 100 patient-years and simulated major bleeding incidence was 2.804-3.238 per 100 patient-years in observational studies. The risk difference of stroke/SE and major bleeding was similar among predicted outcomes of the three observational studies. Most simulated hazard ratios (HRs) were close to the corresponding observed HRs. Conclusion The simulated incidence of stroke/SE incidence and major bleeding might reflect the real-world event rate in AF patients. Even some differences existed in the absolute rates of stroke/SE and major bleeding between observed and simulated studies, the results confirmed similar effectiveness and safety to ROCKET AF comparing rivaroxaban and warfarin in AF patients.