Ichitaro Abe1, Naohiko Takahashi2, Yasushi Mukai3, Tetsuya Kimura4, Keita Yamaguchi4, Atsushi Takita5, Hideki Origasa6, Ken Okumura7. 1. Department of Cardiology and Clinical Examination, Faculty of Medicine, Oita University, 1-1 Idaigaoka, Hasame-machi, Yufu, Oita, 879-5593, Japan. 2. Department of Cardiology and Clinical Examination, Faculty of Medicine, Oita University, 1-1 Idaigaoka, Hasame-machi, Yufu, Oita, 879-5593, Japan. takanao@oita-u.ac.jp. 3. Cardiology Division, Japanese Red Cross Fukuoka Hospital, 3-1-1 Ogusu, Minami-ku, Fukuoka, 815-8555, Japan. 4. Medical Science Department, Daiichi Sankyo Co., Ltd., 3-5-1 Nihombashihoncho, Chuo-ku, Tokyo, 103-8426, Japan. 5. Data Intelligence Department, Daiichi Sankyo Co., Ltd., 3-5-1 Nihombashihoncho, Chuo-ku, Tokyo, 103-8426, Japan. 6. Professor emeritus, The University of Toyama, 2630 Sugitani, Toyama, 930-0194, Japan. 7. Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, 5-3-1 Chikami, Minami Ward, Kumamoto, 861-4193, Japan.
Abstract
BACKGROUND: Data are limited on patient background characteristics associated with catheter ablation (CA)-related bleeding events in Japanese patients with non-valvular atrial fibrillation receiving uninterrupted periprocedural edoxaban. This subanalysis of the KYU-RABLE study focused on univariate and multivariate analyses to identify correlations between bleeding events and baseline patient demographics and CA-related characteristics. METHODS: Patients with non-valvular atrial fibrillation (NVAF) enrolled from the KYU-RABLE study were included in the study. We performed univariate and multivariate analyses to investigate the correlation of major, minor, and clinically relevant non-major bleeding events with the patient baseline data at enrollment, and with CA procedures. RESULTS: A total of 513 NVAF patients were included in the full analysis set. Univariate analysis showed that the incidence of the bleeding events was higher in patients with HAS-BLED score ≥ 3 compared with those with a score < 3 (odds ratio [OR]: 9.48, 95% CI: 2.36-38.01; p = 0.002), in those with creatinine clearance (CrCL) ≤50 mL/min compared with those with CrCL > 50 mL/min (OR: 10.59, 95% CI: 3.65-30.79; p < 0.0001), and in those receiving edoxaban 30 mg compared with those receiving edoxaban 60 mg (OR: 3.49, 95% CI: 1.18-10.38; p = 0.025). Multivariate analysis showed that HAS-BLED score ≥ 3 (OR: 7.93, 95% CI: 1.66-37.88; p = 0.0094) and CrCl ≤ 50 mL/min (OR: 7.78, 95% CI: 2.17-27.90; p = 0.0016) were significant predictors of bleeding events among KYU-RABLE patients. CONCLUSIONS: These predictors of CA-related bleeding events may allow informed decision-making and better AF patient selection for CA with uninterrupted periprocedural edoxaban. TRIAL REGISTRATION: KYU-RABLE, UMIN000029693 . Registered 1 December 2017.
BACKGROUND: Data are limited on patient background characteristics associated with catheter ablation (CA)-related bleeding events in Japanese patients with non-valvular atrial fibrillation receiving uninterrupted periprocedural edoxaban. This subanalysis of the KYU-RABLE study focused on univariate and multivariate analyses to identify correlations between bleeding events and baseline patient demographics and CA-related characteristics. METHODS:Patients with non-valvular atrial fibrillation (NVAF) enrolled from the KYU-RABLE study were included in the study. We performed univariate and multivariate analyses to investigate the correlation of major, minor, and clinically relevant non-major bleeding events with the patient baseline data at enrollment, and with CA procedures. RESULTS: A total of 513 NVAFpatients were included in the full analysis set. Univariate analysis showed that the incidence of the bleeding events was higher in patients with HAS-BLED score ≥ 3 compared with those with a score < 3 (odds ratio [OR]: 9.48, 95% CI: 2.36-38.01; p = 0.002), in those with creatinine clearance (CrCL) ≤50 mL/min compared with those with CrCL > 50 mL/min (OR: 10.59, 95% CI: 3.65-30.79; p < 0.0001), and in those receiving edoxaban 30 mg compared with those receiving edoxaban 60 mg (OR: 3.49, 95% CI: 1.18-10.38; p = 0.025). Multivariate analysis showed that HAS-BLED score ≥ 3 (OR: 7.93, 95% CI: 1.66-37.88; p = 0.0094) and CrCl ≤ 50 mL/min (OR: 7.78, 95% CI: 2.17-27.90; p = 0.0016) were significant predictors of bleeding events among KYU-RABLE patients. CONCLUSIONS: These predictors of CA-related bleeding events may allow informed decision-making and better AFpatient selection for CA with uninterrupted periprocedural edoxaban. TRIAL REGISTRATION: KYU-RABLE, UMIN000029693 . Registered 1 December 2017.
Authors: Eunice Yang; Esra Gucuk Ipek; Muhammad Balouch; Yuliya Mints; Jonathan Chrispin; Joseph E Marine; Ronald D Berger; Hiroshi Ashikaga; Jack Rickard; Hugh Calkins; Saman Nazarian; David D Spragg Journal: Europace Date: 2017-02-01 Impact factor: 5.214
Authors: Riccardo Cappato; Francis E Marchlinski; Stefan H Hohnloser; Gerald V Naccarelli; Jim Xiang; David J Wilber; Chang-Sheng Ma; Susanne Hess; Darryl S Wells; George Juang; Johan Vijgen; Burkhard J Hügl; Richard Balasubramaniam; Christian De Chillou; D Wyn Davies; L Eugene Fields; Andrea Natale Journal: Eur Heart J Date: 2015-05-14 Impact factor: 29.983