Introduction:
Transcatheter arterial embolization (TAE) is recommended to treat the refractory peptic ulcer patients, who continue or recur bleeding after endoscopic hemostasis. Proton pump inhibitors are the main medication for peptic ulcer bleeding. It is unknown whether high dose PPI ameliorate the prognosis after TAE. Therefore, we designed this randomized trial to learn whether high dose PPI strategy was superior than the standard dose strategy.

Methods:
From 2021 January to 2023 October, we prospectively recruited 105 refractory peptic ulcer bleeding patients. All of them had taken transcatheter arterial embolization because of uncontrolled peptic ulcer bleeding after endoscopic hemostasis, and were randomly assigned to standard-dose PPI group (40 mg esomeprazole infusion twice per day for 7 days) or high-dose PPI group (8mg/h esomeprazole infusion for the first 3 days and changed to 40 mg twice per day for the following 4 days) after embolization. The primary endpoint was 30 days rebleeding rate after randomization.

Results:
There were 52 patients in standard-dose PPI group, and 53 patients in large-dose group. The baseline characteristics, including sex, age, hemoglobin concentration (HB), Glasgow-Blatchford score (GBS), endoscopic findings, ulcers size, Forrest classification and history of antiplatelet or anticoagulant were similar in the two groups. In an intention-to-treat (ITT) analysis, 22 (41.5%) in the standard-dose group and 18 (44.0%) in the high-dose group reached the primary endpoint (aHR 1.607, 95%CI 0.862 to 3.031, p=0.142) (Table 1). In a per-protocol (PP) analysis, 13 of 40 (32.5%) in the standard-dose group compared 18 of 52 (34.6%) in the high-dose group occurred rebleeding after TAE (aHR 0.998, 95%CI 0.489 to 2.038, p=0.995) (Table 2). The 30 days all-cause mortality were similar in the two groups (aHR 1.660, 95%CI 0.599 to 4.602, p=0.330 in ITT analysis; aHR 1.954, 95%CI 0.656 to 5.822; p=0.229 in PP analysis) (Table 1-2). In posthoc analysis, high-dose PPI only reduced the 30 days rebleeding rate in patients with Forrest Ia and Ib peptic ulcer (53.6% vs 22.2%, p=0.019) (Figure1).

Conclusion:
In refractory peptic ulcer bleeding patients, high-dose PPI treatment after TAE does not reduce the recurrent bleeding.

Xuefeng Luo

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