• Yuji Nishimoto, Yugo Yamashita, Takeshi Morimoto, Ryuki Chatani, Kazuhisa Kaneda, Nobutaka Ikeda, Yohei Kobayashi, Satoshi Ikeda, Kitae Kim, Moriaki Inoko, Toru Takase, Yukihito Sato, Tetsuya Watanabe, Takahisa Yamada, Masatake Fukunami, Takeshi Kimura, and COMMAND VTE Registry-2 Investigators.
• Division of Cardiology, Osaka General Medical Center, Osaka, Japan; Department of Cardiology, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Japan. Electronic address: yuji.nishimoto@gmail.com.
• Eur. J. Intern. Med. 2024 Sep 1; 127: 748374-83.

BackgroundDirect oral anticoagulants (DOACs) have become widely used for cancer-associated venous thromboembolism (VTE). However, DOAC-associated bleeding complications remain challenging, especially in patients with gastrointestinal (GI) cancer. This study aimed to compare the bleeding outcomes between patients with upper or lower GI cancers and those without GI cancer.MethodsUsing the COMMAND VTE Registry-2 database, which is a multicenter registry enrolling 5197 consecutive acute symptomatic VTE patients among 31 centers in Japan between January 2015 and August 2020, we identified 1149 active cancer patients with DOACs (upper GI cancer: N = 88; lower GI cancer: N = 114; non-GI cancer: N = 947). The primary outcome was major bleeding during anticoagulation therapy, which was evaluated in the competing risk regression model.ResultsThe upper GI cancer group had a lower mean body weight, and most often had anemia. The cumulative 5-year incidence of major bleeding was higher in the upper GI cancer group (upper GI cancer: 22.4 %, lower GI cancer: 15.4 %, and non-GI cancer: 11.6 %, P = 0.015). The most frequent major bleeding site in the upper GI cancer group was the upper GI (53 %), followed by the lower GI (24 %). After adjusting for the confounders, the excess risk in upper GI cancer relative to non-GI cancer remained significant for major bleeding (adjusted subhazard ratio, 2.25; 95 %CI, 1.31-3.87, P = 0.003), but that in lower GI cancer was insignificant.ConclusionsUpper GI cancer, but not lower GI cancer, as compared to non-GI cancer was associated with a higher risk for major bleeding during anticoagulation therapy with DOACs.Clinical Trial RegistrationURL: http://www.umin.ac.jp/ctr/index.htm Unique identifier: UMIN000044816.Copyright © 2024 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

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