Abe Ichitaro, Takahashi Naohiko, Mukai Yasushi, Kimura Tetsuya, Yamaguchi Keita, Takita Atsushi, Origasa Hideki, Okumura Ken
Department of Cardiology and Clinical Examination, Faculty of Medicine, Oita University, 1-1 Idaigaoka, Hasame-machi, Yufu, Oita, 879-5593, Japan.
Cardiology Division, Japanese Red Cross Fukuoka Hospital, 3-1-1 Ogusu, Minami-ku, Fukuoka, 815-8555, Japan.
Thromb J. 2021 Aug 3;19(1):53. doi: 10.1186/s12959-021-00305-7.
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.
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.
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.
These predictors of CA-related bleeding events may allow informed decision-making and better AF patient selection for CA with uninterrupted periprocedural edoxaban.
KYU-RABLE, UMIN000029693 . Registered 1 December 2017.
在接受不间断围手术期依度沙班治疗的日本非瓣膜性心房颤动患者中，与导管消融（CA）相关出血事件相关的患者背景特征数据有限。这项对KYU-RABLE研究的亚分析侧重于单变量和多变量分析，以确定出血事件与患者基线人口统计学和CA相关特征之间的相关性。
纳入KYU-RABLE研究中登记的非瓣膜性心房颤动（NVAF）患者。我们进行了单变量和多变量分析，以研究主要、次要和临床相关非主要出血事件与入组时患者基线数据以及CA手术之间的相关性。
共有513例NVAF患者纳入全分析集。单变量分析显示，HAS-BLED评分≥3分的患者出血事件发生率高于评分<3分的患者（比值比[OR]：9.48，95%置信区间：2.36-38.01；p=0.002），肌酐清除率（CrCL）≤50 mL/min的患者高于CrCL>50 mL/min的患者（OR：10.59，95%置信区间：3.65-30.79；p<0.0001），接受30 mg依度沙班的患者高于接受60 mg依度沙班的患者（OR：3.49，95%置信区间：1.18-10.38；p=0.025）。多变量分析显示，HAS-BLED评分≥3分（OR：7.93，95%置信区间：1.66-37.88；p=0.0094）和CrCl≤50 mL/min（OR：7.78，95%置信区间：2.17-27.90；p=0.0016）是KYU-RABLE研究患者出血事件的显著预测因素。
这些CA相关出血事件的预测因素可能有助于在不间断围手术期依度沙班治疗的情况下，做出明智的决策并更好地选择适合CA的房颤患者。
KYU-RABLE，UMIN000029693。2017年12月1日注册。
