Open Access
CC BY-NC-ND 4.0 · Endosc Int Open 2019; 07(02): E104-E114
DOI: 10.1055/a-0754-1997
Original article
Owner and Copyright © Georg Thieme Verlag KG 2019

A prospective multicenter observational study evaluating the risk of periendoscopic events in patients using anticoagulants: the Osaka GIANT Study

Takuya Inoue*
 1   Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan
 2   Department of Gastroenterology, Osaka General Medical Center, Osaka, Japan
,
Hideki Iijima*
 1   Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan
,
Takuya Yamada
 3   Department of Gastroenterology, National Hospital Organization Osaka National Hospital, Osaka, Japan
,
Yuji Okuyama
 4   Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan
,
Kanae Takahashi
 5   Department of Medical Statistics, Osaka City University Graduate School of Medicine, Osaka, Japan
,
Tsutomu Nishida
 6   Department of Gastroenterology, Toyonaka Municipal Hospital, Toyonaka, Osaka, Japan
,
Ryu Ishihara
 7   Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan
,
Tomofumi Akasaka
 7   Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan
,
Ichizo Kobayashi
 8   Department of Gastroenterology, Higashiosaka City Medical Center, Higashiosaka, Osaka, Japan
,
Toshio Kuroshima
 9   Department of Gastroenterology, Suita Municipal Hospital, Suita, Osaka, Japan
,
Yuichi Yasunaga
10   Department of Gastroenterology, Hyogo Prefectural Nishinomiya Hospital, Nishinomiya, Hyogo, Japan
,
Katsumi Yamamoto
11   Department of Gastroenterology, Japan Community Health Care Organization Osaka Hospital, Osaka, Japan
,
Masanori Nakahara
12   Department of Gastroenterology, Ikeda Municipal Hospital, Ikeda, Osaka, Japan
,
Yoshinori Doi
13   Department of Gastroenterology, Otemae Hospital, Osaka, Japan
,
Sachiko Nakajima
 6   Department of Gastroenterology, Toyonaka Municipal Hospital, Toyonaka, Osaka, Japan
,
Akira Mukai
14   Department of Gastroenterology, Sumitomo Hospital, Osaka, Japan
,
Eiji Masuda
15   Department of Gastroenterology, National Hospital Organization Osaka-Minami National Hospital, Osaka, Japan
,
Shunsuke Yoshii
 1   Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan
,
Yoshito Hayashi
 1   Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan
,
Hitoshi Minamiguchi
 4   Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan
,
Yasushi Sakata
 4   Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan
,
Kouji Yamamoto
 5   Department of Medical Statistics, Osaka City University Graduate School of Medicine, Osaka, Japan
,
Masahiko Tsujii
 8   Department of Gastroenterology, Higashiosaka City Medical Center, Higashiosaka, Osaka, Japan
,
Tetsuo Takehara
 1   Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan
› Institutsangaben
TRIAL REGISTRATION: multi-center, observational and prospective study at umin.ac.jp
Weitere Informationen

Publikationsverlauf

submitted28. März 2018

accepted after revision22. August 2018

Publikationsdatum:
17. Januar 2019 (online)

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Abstract

Background and study aims An increasing number of patients have been using anticoagulants including anti-vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs); however, in patients using anticoagulants, limited data are available with regard to the risks of gastrointestinal bleeding and thromboembolic events during the peri-endoscopic period. We aimed to evaluate the peri-endoscopic bleeding and thrombotic risks in patients administered VKAs or DOACs.

Patients and methods Consecutive patients using anticoagulants who underwent endoscopic biopsy, mucosal resection, or submucosal dissection were prospectively enrolled across 11 hospitals. The primary outcome assessed was difference in incidence of post-procedural gastrointestinal bleeding in patients using VKAs and DOACs. Duration of hospitalization and peri-procedural thromboembolic events were also compared.

Results We enrolled 174 patients using VKAs and 37 using DOACs. In total, 16 patients using VKA were excluded from the analysis because of cancellation of endoscopic procedures and contraindications to the use of DOACs; 128 (81 %) patients using VKAs and 17 (46 %) using DOACs received heparin-bridging therapy (HB). The rate of post-procedural gastrointestinal bleeding in DOAC users was similar to that in VKA users (16.2 % vs. 16.4 %, P = 1.000). Duration of hospitalization was significantly longer in patients using VKAs than in those using DOACs (median 15 vs. 7 days, P < 0.0001). Myocardial infarction occurred during pre-endoscopic HB in one patient using VKAs.

Conclusion DOAC administration showed similar post-procedural gastrointestinal bleeding risk to VKA administration in patients undergoing endoscopic procedures, but it shortened the hospital stay.

* These authors contributed equally to the study.