Yoshida Naohisa, Hayashi Yoshikazu, Togo Daichi, Oka Shiro, Takada Kazunori, Fukunaga Shusei, Morita Yoshinori, Hayashi Takemasa, Kozuka Kazuhiro, Tsuji Yosuke, Murakami Takashi, Yamamura Takeshi, Komeda Yoriaki, Takeuchi Yoji, Shinmura Kensuke, Fukuda Hiroko, Yoshii Shinji, Ono Shoko, Katsuki Shinichi, Kawashima Kazumasa, Nemoto Daiki, Yamamoto Hiroyuki, Saito Yutaka, Tamai Naoto, Iwao Aya, Itoi Yuki, Tsuji Shigetsugu, Inagaki Yoshikazu, Inada Yutaka, Soga Koichi, Hasegawa Daisuke, Murakami Takaaki, Yoriki Hiroyuki, Fukumoto Kohei, Motoyoshi Takayuki, Nakatani Yasuki, Sano Yasushi, Iguchi Mikitaka, Fujii Shigehiko, Ban Hiromitsu, Harada Keita, Okamoto Koichi, Nishiyama Hitoshi, Sasaki Fumisato, Mizukami Kazujhiro, Shono Takashi, Shimoda Ryo, Miike Tadashi, Yamaguchi Naoyuki
Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Department of Medicine, Division of Gastroenterology, Jichi Medical University, Tochigi, Japan.
Clin Gastroenterol Hepatol. 2024 Feb;22(2):271-282.e3. doi: 10.1016/j.cgh.2023.09.012. Epub 2023 Sep 22.
BACKGROUND & AIMS: Reported rates of delayed bleeding (DB) after endoscopic resection using direct oral anticoagulants (DOACs) are high and heterogeneous. This large-scale multicenter study analyzed cases of DB after colorectal endoscopic submucosal dissection related to various types of DOACs in Japan (the ABCD-J study) with those associated with warfarin.
We retrospectively reviewed 1019 lesions in patients treated with DOACs and 459 lesions in patients treated with warfarin among 34,455 endoscopic submucosal dissection cases from 47 Japanese institutions between 2012 and 2021. The DB rate (DBR) with each DOAC was compared with that with warfarin. Risk factors for DB in patients treated with DOACs or warfarin were also investigated.
The mean tumor sizes in the DOAC and warfarin groups were 29.6 ± 14.0 and 30.3 ± 16.4 mm, respectively. In the DOAC group, the DBR with dabigatran (18.26%) was significantly higher than that with apixaban (10.08%, P = .029), edoxaban (7.73%, P = .001), and rivaroxaban (7.21%, P < .001). Only rivaroxaban showed a significantly lower DBR than warfarin (11.76%, P = .033). In the multivariate analysis, heparin bridging therapy (odds ratio [OR], 2.18; 95% confidence interval [CI], 1.27-3.73, P = .005), rectal location (2.01, 1.28-3.16, P = .002), and procedure time ≥55 minutes (2.43, 1.49-3.95, P < .001) were significant risk factors for DB in the DOAC group. The DB risk in the DOAC group (OR, (95% CI)) was 2.13 (1.30-3.50) and 4.53 (2.52-8.15) for 1 and 2 significant risk factors, respectively.
Dabigatran was associated with a higher DBR than other DOACs, and only rivaroxaban was associated with a significantly lower DBR than warfarin.
使用直接口服抗凝剂(DOACs)进行内镜切除术后延迟出血(DB)的报告发生率较高且存在异质性。这项大规模多中心研究分析了日本结直肠内镜黏膜下剥离术后与各类DOACs相关的DB病例(ABCD-J研究),并与华法林相关病例进行了比较。
我们回顾性分析了2012年至2021年间日本47家机构的34455例内镜黏膜下剥离病例中,接受DOACs治疗患者的1019个病变以及接受华法林治疗患者的459个病变。比较了每种DOAC的延迟出血率(DBR)与华法林的延迟出血率。还调查了接受DOACs或华法林治疗患者发生DB的危险因素。
DOAC组和华法林组的平均肿瘤大小分别为29.6±14.0mm和30.3±16.4mm。在DOAC组中,达比加群的DBR(18.26%)显著高于阿哌沙班(10.08%,P = 0.029)、依度沙班(7.73%,P = 0.001)和利伐沙班(7.21%,P < 0.001)。只有利伐沙班的DBR显著低于华法林(11.76%,P = 0.033)。在多变量分析中,肝素桥接治疗(比值比[OR],2.18;95%置信区间[CI],1.27 - 3.73,P = 0.005)、直肠部位(2.01,1.28 - 3.16,P = 0.002)以及手术时间≥55分钟(2.43,1.49 - 3.95,P < 0.001)是DOAC组发生DB的显著危险因素。DOAC组中,有1个和2个显著危险因素时的DB风险(OR,(95% CI))分别为2.13(1.30 - 3.50)和4.53(2.52 - 8.15)。
达比加群的DBR高于其他DOACs,只有利伐沙班的DBR显著低于华法林。