Yoshida Yukihiko, Watarai Masato, Fujii Kenshi, Shimizu Wataru, Satomi Kazuhiro, Inden Yasuya, Murakami Yoshimasa, Murakami Masato, Iwasa Atsushi, Kimura Masaomi, Yamada Nobuko, Nakagawa Tomofumi, Nordaby Matias, Okumura Ken
Department of Cardiology Japanese Red Cross Nagoya Daini Hospital Nagoya Aichi Japan.
Department of Cardiology Aichi Prefectural Welfare Federation of Agricultural Co-operative Associations Anjo-kosei Hospital Anjo Aichi Japan.
J Arrhythm. 2018 Jan 13;34(2):148-157. doi: 10.1002/joa3.12024. eCollection 2018 Apr.
There are limited data on uninterrupted anticoagulation with direct oral anticoagulants during catheter ablation for atrial fibrillation (AF), particularly in Japan. We planned a subgroup analysis of the RE-CIRCUIT study, comparing the use of uninterrupted dabigatran therapy with warfarin therapy during catheter ablation among the Japanese subgroup and with that in the total population.
The RE-CIRCUIT study utilized a prospective, randomized, open-label, blinded endpoint design, and the primary endpoint was the incidence of major bleeding events (MBEs). Patients were randomized to uninterrupted dabigatran 150 mg twice daily or warfarin. In this study, we analyzed the results in Japanese patients.
Of 704 enrolled patients in the study, 112 Japanese patients were randomized to dabigatran (n = 65) or warfarin (n = 47). MBEs were experienced by two patients: one in the dabigatran group (1.6%, cardiac tamponade) and one in the warfarin group (2.2%, groin hematoma) (risk difference vs warfarin -0.6%; 95% CI -5.8, 4.7). Within the Japanese subgroup, there were no thromboembolic events in both groups.
While not designed to show statistical difference between two treatment groups, our results from the Japanese subgroup supported those from the overall population. Furthermore, this study provided clinical information regarding MBE, especially cardiac tamponade, in Japanese patients.
关于房颤(AF)导管消融期间直接口服抗凝剂持续抗凝的数据有限,尤其是在日本。我们计划对RE-CIRCUIT研究进行亚组分析,比较日本亚组和总体人群中导管消融期间达比加群持续治疗与华法林治疗的情况。
RE-CIRCUIT研究采用前瞻性、随机、开放标签、盲法终点设计,主要终点是大出血事件(MBE)的发生率。患者被随机分为每日两次服用150毫克达比加群或华法林。在本研究中,我们分析了日本患者的结果。
在该研究纳入的704例患者中,112例日本患者被随机分为达比加群组(n = 65)或华法林组(n = 47)。两名患者发生了MBE:达比加群组1例(1.6%,心脏压塞),华法林组1例(2.2%,腹股沟血肿)(与华法林相比风险差异为-0.6%;95%CI -5.8,4.7)。在日本亚组中,两组均未发生血栓栓塞事件。
虽然本研究并非旨在显示两个治疗组之间的统计学差异,但我们从日本亚组获得的结果支持了总体人群的结果。此外,本研究提供了有关日本患者MBE尤其是心脏压塞的临床信息。