Efficacy of vonoprazan for the prevention of bleeding after gastric endoscopic submucosal dissection with continuous use of antiplatelet agents

Abstract

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.

Incidence and type of adverse events in patients taking vonoprazan: A systematic review and meta-analysis

“… 25 , 26 , 28 – 30 , 39 , 40 , 45 , 48 , 49 , 58 , 68 – 70 , 73 , 76 , 78 , 82 , 88 The indications for vonoprazan included H. pylori infection ( n = 49), 11 , 15 , 19 , 22 – 27 , 29 , 30 , 33 , 34 , 36 , 37 , 39 – 41 , 45 – 47 , 50 – 53 , 56 , 58 , 59 , 62 – 67 , 71 …”

“…25,26,[28][29][30]39,40,45,48,49,58,[68][69][70]73,76,78,82,88 The indications for vonoprazan included H. pylori infection (n = 49), 11,15,19,[22][23][24][25][26][27]29,30,33,34,36,37,[39][40][41][45][46][47][50][51][52][53]56,58,59,[62][63][64][65][66][67]…”

The degree of mucosal atrophy is associated with post‐endoscopic submucosal dissection bleeding in early gastric cancer

“…Considering that the effect of gastric acid secretion on post-ESD bleeding is known, acid secretion inhibitors are commonly administered after ESD. 6 The benefit of administering PCABs to patients with post-ESD bleeding has been reported, 29,30 with PCABs being noninferior to PPIs in reducing the incidence of post-ESD bleeding, although not superior. 31 The small number of patients taking PCABs in this study makes it difficult to evaluate the efficacy of PCABs in post-H. pylori eradication patients with a mild degree of atrophy.…”

Review article: potassium‐competitive acid blockers for the treatment of acid‐related disorders

“…PPIs have been recommended after ESD for healing of ulcers and prevention of bleeding 43,44 . Studies examining vonoprazan for healing of post‐ESD gastric ulcers and/or the prevention of delayed bleeding from post‐ESD gastric ulcers are summarised in Table 5 45‐53 . In general, vonoprazan has been at least non‐inferior to PPIs in healing post‐ESD gastric ulcers and similar with respect to rates of delayed bleeding.…”