Vonoprazan or Proton Pump Inhibitor for Gastric Endoscopic Submucosal Dissection in Patients Taking Antithrombotic Agents

Abstract

Background and Aim: Delayed bleeding is a major concern after gastric endoscopic submucosal dissection (ESD), especially in patients taking antithrombotic agents. The aim of this study was to evaluate the superiority of vonoprazan (VPZ) over proton pump inhibitor (PPI) in preventing delayed bleeding after gastric ESD in patients taking antithrombotic agents. Methods: A multicenter, open-label, randomized controlled trial was conducted in 10 Japanese centers. Gastric neoplasm patients taking antiplatelets or anticoagulants were enrolled and randomly allocated in a 1:1 ratio to either the VPZ (20 mg per day for 8 weeks) or the PPI group (esomeprazole 20 mg per day for 8 weeks). Antithrombotic agents were managed according to Japanese guidelines. The primary outcome was the delayed bleeding rate within 8 weeks after ESD. Secondary outcomes included the incidence of symptoms after ESD, healing status of ulcers at 8 weeks, safety, and factors related to delayed bleeding. Results: Of 119 patients (59 in VPZ group, 60 in PPI group), the delayed bleeding rates were 13.6% (8/59) in the VPZ group and 8.3% (5/60) in the PPI group, with no significant difference (p = 0.36). Symptoms and adverse events, the healing status of ulcers at 8 weeks, were comparable between the groups. No use of daily antacids and the combination of antiplatelets and anticoagulants were related to delayed bleeding (odds ratio 13.1 and 34.7, p < 0.01). Conclusion: The present study did not demonstrate the superiority of VPZ over PPIs in preventing delayed bleeding after gastric ESD in patients taking antithrombotic agents. Trial Registration: (UMIN000040641/jRCTs041200045).