Background Post-procedural
bleeding, after gastric endoscopic submucosal dissection (ESD) for high risk thromboembolic cases that require continuous antiplatelet
therapy, is challenging. Its incidence rate is > 20 % among those using conventional
antacids. We evaluated the efficacy of perioperative management with
vonoprazan to prevent post-ESD
bleeding. Materials and methods This was a multicenter prospective interventional trial conducted
at 10 Japanese referral centers. Patients who regularly used
antiplatelet agents (
aspirin or
thienopyridine derivatives, etc.) and who required continuous antithrombotic medication due to high thromboembolic risk were enrolled. They underwent gastric ESD with continuous
aspirin therapy.
Oral administration of
vonoprazan (20 mg daily) was started from the day of ESD and continued for 28 days. The primary end point was the incidence of post-ESD
bleeding. The sample size was 50 patients, and
vonoprazan was considered to be effective when the upper threshold of the 95 % confidence interval (CI) for post-ESD
bleeding did not exceed 20 %. Results Although 50 patients were enrolled, one patient withdrew consent. Therefore, 49 patients were included in the analysis. One patient who used
aspirin and
clopidogrel experienced
bleeding 11 days after ESD. The overall post-ESD
bleeding rate was 2.0 % (1/49; 95 %CI 0.4-10.7 %). Thromboembolic events were not observed. One case of ESD-associated adverse events (perforation) and one case of
drug-associated adverse events (
drug eruption, possibly due to
vonoprazan) were observed. Conclusions Vonoprazan may be efficacious for preventing post-ESD
bleeding in patients using continuous antiplatelet
therapy, warranting further comparative study to definitively test the effectiveness of the
drug.