Current Real-World Status of Off-Label Under- and Over-Dose of Direct Oral Anticoagulants After Atrial Fibrillation Ablation.

Off-label under- and overdosing of direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF) is not uncommon in real-world practice. This study aimed to identify efficacy and safety of off-label DOACs dose after AF ablation. The RYOUMA registry was a prospective multicenter study of Japanese patients who underwent AF ablation between 2017 and 2018. DOAC prescriptions were categorized into on-label standard dose, on-label reduced dose, off-label underdose, and off-label overdose. The proportion of off-label doses among patients after AF ablation varied depending on the type of DOAC, ranging from 13.5% to 34.9%. Of 2821 patients, 366 (13.0%) were prescribed an off-label underdose and exhibited significantly higher CHADS2, CHA2DS2-VASc, CHA2DS2-VA, HELT-E2S2, and HAS-BLED scores, age, concomitant use of antiplatelets, and lower weight when compared to the on-label standard dose (n = 1809). While the incidence of ischemic stroke after 1 year of off-label underdose was notably low (0.28%), the rate of major bleeding was relatively high (1.7%). Off-label overdose was prescribed to 134 patients (4.8%), who showed a significantly higher incidence of major bleeding (3.0%) compared to on-label standard dose (0.91%; p = 0.02). The off-label overdose group did not have any particular background and its thromboembolic risk was, conversely, low. The most likely cause of off-label overdose was clinicians potentially overlooking dose criteria, including advanced age, low body weight, and low creatinine clearance. In patients after AF ablation, off-label DOAC overdose was infrequent, but significantly associated with higher incidence of major bleeding during the remote period after AF ablation. The study was registered as UMIN000026092 (University Hospital Medical Information Network-Clinical Trial Registry).

Kino T ，Nogami A ，Soejima K ，Uno K ，Kumagai K ，Kurita T ，Fukuzawa M ，Takita A ，Ishizu T ，Aonuma K ，and other members of the RYOUMA Registry Investigators ... -  《-》

Assessment of Long-Term Use Versus Discontinuation of Direct Oral Anticoagulant After Catheter Ablation for Atrial Fibrillation-RYOUMA Registry Subanalysis.

The relationship between oral anticoagulant (OAC) status after catheter ablation (CA) for atrial fibrillation (AF) and the risks of ischemic stroke or major bleeding events is still unknown. This is a subanalysis of the RYOUMA registry, a prospective multicenter observational study of Japanese patients who underwent CA for AF in 2017-2018. Of the 2844 patients, the rate of DOAC continuation was 48.1%, 69.6%, and 80.9% in patients with a CHADS2 score of 0-1, 2, and 3-6, respectively. Among the patients taking DOACs with a CHADS2 score of 0-1 and 2, the incidence rates of major bleeding were significantly higher than those of ischemic stroke or systemic embolic events (SEEs) (1.3%/year [95% CI, 0.6-2.1] vs. 0.3%/year [95% CI, 0.0-0.7], p = 0.019; 1.8%/year [95% CI, 0.6-3.0] vs. 0.2%/year [95% CI, 0.0-0.6], p = 0.018, respectively). However, there was no difference between the incidence rates of major bleeding events and ischemic stroke or SEEs in patients taking DOACs with a CHADS2 score of 3-6 (1.6%/year [95% CI, 0.2-3.0] vs. 1.0%/year [95% CI, 0.0-2.1], p = 0.474). In patients with a CHADS2 score of 2, those who continued taking DOACs had a higher incidence rate of major bleeding events compared to ischemic stroke/SEEs, similar to those with a CHADS2 score of 0-1. Conversely, in patients with a CHADS2 score of 3-6, the incidence rates of both ischemic stroke/SEEs and major bleeding were similarly high. The study was registered as UMIN000026092 (University Hospital Medical Information Network-Clinical Trial Registry).

Oda Y ，Nogami A ，Komatsu Y ，Soejima K ，Morishima I ，Hiroshima K ，Kato R ，Sakagami S ，Miura F ，Okawa K ，Fukuzawa M ，Takita A ，Uno K ，Kumagai K ，Kurita T ，Gosho M ，Ishizu T ，Aonuma K ，RYOUMA Investigators ... -  《-》

Clinical Outcomes of Off-Label Dosing of Direct Oral Anticoagulant Therapy Among Japanese Patients With Atrial Fibrillation Identified From the SAKURA AF Registry.

Murata N ，Okumura Y ，Yokoyama K ，Matsumoto N ，Tachibana E ，Kuronuma K ，Oiwa K ，Matsumoto M ，Kojima T ，Hanada S ，Nomoto K ，Arima K ，Takahashi F ，Kotani T ，Ikeya Y ，Fukushima S ，Itoh S ，Kondo K ，Chiku M ，Ohno Y ，Onikura M ，Hirayama A ，SAKURA AF Registry Investigators ... -  《-》

Direct Oral Anticoagulants Versus Warfarin Across the Spectrum of Kidney Function: Patient-Level Network Meta-Analyses From COMBINE AF.

Harrington J ，Carnicelli AP ，Hua K ，Wallentin L ，Patel MR ，Hohnloser SH ，Giugliano RP ，Fox KAA ，Hijazi Z ，Lopes RD ，Pokorney SD ，Hong H ，Granger CB ... -  《-》

Relationship Between Direct Oral Anticoagulant Doses and Clinical Outcomes in Elderly Patients With Non-Valvular Atrial Fibrillation　- ANAFIE Registry Sub-Analysis.

Akao M ，Inoue H ，Yamashita T ，Atarashi H ，Ikeda T ，Koretsune Y ，Okumura K ，Suzuki S ，Tsutsui H ，Toyoda K ，Hirayama A ，Yasaka M ，Yamaguchi T ，Teramukai S ，Kimura T ，Morishima Y ，Takita A ，Shimizu W ... -  《-》