Effect of Dabigatran Replacement on Post-ESD Bleeding in Anticoagulated Patients Undergoing Gastric ESD: A Multicenter Prospective Study

Aims Patients taking anticoagulants, including direct oral anticoagulants (DOACs) and warfarin, are considered high-risk in gastric endoscopic submucosal dissection (ESD) because of their significantly increased risk of postoperative bleeding and thromboembolic complications. In a previous retrospective study, we reported that post-ESD bleeding in patients taking dabigatran was less frequent compared to those with other anticoagulants, which can be explained by the differences in their metabolic pathways. We hypothesized that replacing other DOACs and warfarin with dabigatran after gastric ESD could reduce post-ESD bleeding. Methods We conducted a single-arm multicenter prospective study in which anticoagulants were replaced with dabigatran after ESD in patients with gastric neoplasms eligible for ESD who were continuously taking rivaroxaban, apixaban, edoxaban or warfarin to prevent thromboembolism due to nonvalvular atrial fibrillation. Patient enrollment occurred from February 2019 to February 2025 at 20 institutions across Japan. DOACs were discontinued on the day of ESD, and dabigatran was taken starting from the next day for 28 days. Patients on warfarin either stopped the medication one day before or on the day of ESD depending on PT-INR. Another option was to discontinue warfarin four days prior and use heparin bridging. Dabigatran was initiated after ESD when PT-INR dropped less than 2.0. Anticoagulant therapy was switched back to the original agent on postoperative day 28, with follow-up continuing until day 56, at which point the patient underwent endoscopy and final evaluation. The primary outcome was the post-ESD bleeding rate. Delayed bleeding was significantly reduced with dabigatran bridge when the 90% confidence interval (CI) did not exceed the 18% threshold, which represented the estimated rate for patients on other anticoagulants. Results In total, 150 patients were enrolled, and 140 patients completed the protocol treatment. Male patients accounted for 86%, with a median age of 77.5 years. Antiplatelet use was observed in 12%, and the median CHADS₂ score was 2. The post-ESD bleeding rate was 10% (90% CI, 6.3-15.0). Although thromboembolism occurred in one case (0.7%) as a cerebral infarction, the patient recovered without significant paralysis. Two cases (1.3%) of perforation during ESD were observed and were successfully managed with conservative treatment. Conclusions Switching to dabigatran reduces postoperative bleeding following gastric ESD in patients taking anticoagulants for nonvalvular atrial fibrillation, and represents a simple and effective strategy that can be easily combined with other preventive measures. (UMIN-CTR000035353) Article published online: 05 June 2026 © 2026. European Society of Gastrointestinal Endoscopy. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany