Current use of direct oral anticoagulants for atrial fibrillation in Japan: Findings from the SAKURA AF Registry

Abstract

BackgroundLarge-scale investigations on the use of oral anticoagulants including direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF) have not included Japanese patients.MethodsWe established the multicenter SAKURA AF Registry to support prospective observational research on the status of anticoagulation treatment, especially with DOAC, for AF in Japan. We enrolled 3266 AF patients treated with warfarin (n=1577) or any of 4 DOACs (n=1689) from 63 institutions (2 cardiovascular centers, 13 affiliated hospitals or community hospitals, and 48 private clinics) in the Tokyo area.ResultsWe conducted our first analysis of the registry data, and although we found equivalent mean age between the DOAC and warfarin users (71.8±9.5 vs. 72.3±9.4 years, p=0.2117), we found a slightly lower risk of stroke (CHADS2 score of 0 or 1 [46.9% vs. 39.4%, p<0.0001]) and significantly better creatinine clearance in DOAC users (70.4±27 vs. 65.6±25.7 mL/min, p<0.0001). Importantly, we documented under-dosing in 32% of warfarin users and inappropriate-low-dosing in 19.7–27.6% of DOAC users.ConclusionsOur initial analysis of the SAKURA AF Registry data clarified the real-world use of anticoagulants, which includes DOACs and warfarin in Japan. The DOAC users were at a lower risk for stroke than the warfarin users. In 20–30% of DOAC users, the dose was inappropriately reduced.

Safety and effectiveness of apixaban in Japanese patients with nonvalvular atrial fibrillation in clinical practice: A regulatory postmarketing surveillance, the STANDARD study

“…In the present study, 42.7% of the patients received 2.5 mg BID apixaban. This frequency was similar to that in Japanese registration studies (40.4% and 44%), but lower than that in a Japanese claims database study (60.6%).…”

Design and baseline characteristics of the Xarelto Post‐Authorization Safety & Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS)

“…A recent subanalysis of the J‐RHYTHM Registry suggested that patients with lower CHADS 2 scores benefit from anticoagulation, which might lead to the prescription of rivaroxaban for such patients. Compared with the XAPASS, the percentage of patients with a CHADS 2 score of 0 or 1 was higher in other AF registries such as the J‐RHYTHM Registry (49.6%) and the SAKURA AF Registry (43.3%) . This might be explained by the fact that the Japanese guideline recommends rivaroxaban for high‐risk patients with a CHADS 2 score of ≥2.…”

Impact of direct oral anticoagulant off‐label doses on clinical outcomes of atrial fibrillation patients: A systematic review

“…Real‐world studies demonstrated that low doses of dabigatran and edoxaban are preferentially prescribed and their inappropriate low dosing (ILD) is greater than appropriate low dosing. This trend towards the use of ILD may be due to the reported evidence of the effectiveness of both drugs at low doses …”

“…(C) Real‐world studies results concerning dose adjustments of apixaban. (D) Results from direct oral anticoagulants overall adjustments regarding dose appropriateness…”