OTSC System Clip for endoscopic treatment of gastrointestinal hemorrhage and closure of acute and chronic wall lesions Ovesco Endoscopy

OTSC® superior to TAE in refractory peptic ulcer bleeding – study shows significantly lower in-hospital mortality and shorter ICU stay

Compared to patients treated with transcatheter arterial embolization (TAE) for refractory peptic ulcer bleedings, OTSC® showed higher efficacy (72.5% vs. 62.5% (p = 0.474)) and significantly reduced length of stay in ICU (4.9 vs. 9.2 days p = 0.009) as well as a significantly reduced in-house mortality (5.0% vs. 22.5% (p = 0.048)).

A. Küllmer et al., Medical Center University of Freiburg, Freiburg, Germany, presented a retrospective multicenter study comparing OTSC vs TAE (transarterial angiographic embolization) as salvage/bailout therapy for refractory peptic ulcer bleeding at this year’s virtual UEG Week. Results of the study were also presented at this year’s DGVS/DGAV conference (conference of the German Society of Gastroenterology, and Digestive and Metabolic Diseases with Endoscopy Section (DGVS) and the German Society of General Surgery and Visceral Surgery (DGAV)).

Primary endpoint of the study was clinical success defined as the combined endpoint of successful hemostasis and no re-bleeding within 7 days. Secondary endpoints were adverse events, length of hospital stay, days on intensive care unit (ICU), number of blood transfusions and mortality. Statistical analysis was performed for the total cohort and a matched cohort after adjustment of differences in baseline characteristics with propensity score matching (PSM).
Overall, 128 patients with peptic ulcer bleeding refractory to standard endoscopic therapy were included in the study. 66 patients were treated with OTSC, 62 patients with TAE.
Between the two comparison groups there were no significant differences regarding age, Charlson comorbidity index, Rockall score, Helicobacter pylori status, ongoing anticoagulation, NSAID intake, primary hemostasis rate in first line therapy and number of endoscopic treatment attempts before salvage therapy. Also, in both groups, the proportion of patients with ulcer size > 20mm was similar (27.3 % vs. 33.9 %, p = 0.48). Most ulcers were in the duodenal bulb (65 % in OTSC group; 85.5 % in the TAE group; p = 0.014). The OTSC group included significantly less Forrest Ia bleedings (19.7 % vs. 38.7 %, p = 0.02) and significantly more Forrest Ib bleedings (63.6 % vs. 43.5 %; p = 0.03). PSM was performed to control for these biases and resulting in treatment groups of n = 40 each, with no significant differences in ulcer localization and bleeding characteristics.

Clinical success was higher in the OTSC group but did not reach statistical significance (72.5 % vs. 62.5 %; p = 0.474) while TAE patients stayed significantly longer in ICU (4.9 vs. 9.2 days, p = 0.009) and inhospital mortality was significantly higher in the TAE group (5.0 % vs. 22.5 %, p = 0.048). The 7-day rebleeding rate was higher in the TAE group (17.5 % vs. 32.5 %; p = 0.196). Also, severe adverse events occurred more often in the TAE group (3.0 % vs. 7.5 %, p = 0.308).

The authors concluded that OTSC treatment for refractory peptic ulcer bleeding shows at least similar efficacy compared to TAE, but significantly lower mortality rates and significantly shorter ICU stay.

OTSC vs TAE as salvage therapy for refractory peptic ulcer bleeding
Kuellmer A, Mangold T, Bettinger D, Maruschke L, Wannhoff A, Caca k Edris W, Jung C, Kleemann T, Schulz T, Thimme R, Schmidt A.
United European Gastroenterology Week Virtual 2020, Congress lecture, 2020 October 11