Multicenter evaluation of first-line endoscopic treatment with the OTSC in acute non-variceal upper gastrointestinal bleeding and comparison with the Rockall cohort: the FLETRock study

The over-the-scope clip (OTSC) overcomes limitations of standard clips and achieves a more efficient and reliable hemostasis in non-variceal upper gastrointestinal bleeding (NVUGIB). The study aims to evaluate mortality, rebleeding, and mortality after rebleeding of patients in whom the OTSC was used as the first-line endoscopic treatment (FLET) of NVUGIB. In total, 118 patients (FLET cohort) with a median age of 73.5 years (range 29-93 years; mean (+/- SD) 71.39 +/- 12.39 years) were included. The distribution of patients with respect to risk category revealed a median Rockall score of 7 (range 3-10). For hypothesis testing, the FLET cohort was categorized into three risk groups taking into account the Rockall score: low risk [Rockall risk category (RRC >= 3)], moderate risk (RRC 4-7), and high risk (RRC <= 8). Event rates (mortality, rebleeding, and mortality after rebleeding) observed per risk group were compared to predicted event rates (Rockall cohort) using Fisher's Exact Test. Primary successful hemostasis (PSH) was achieved in 92.4% either by FLET alone or in combination with an additional hemostasis technique in 1.7% (SCS = secondary clinical success). In 7.5% of the FLET cohort PSH could not be achieved. Compared to RRC prediction, mortality after rebleeding was significantly reduced from 27.9 to 10.9% in the high-risk group (RRC <= 8) treated with FLET (p < 0.011). Furthermore, the occurrence of rebleeding or continued bleeding was significantly lower in the moderate risk group (RRC 4-7) with 4.9% as well as in the high-risk group (RRC <= 8) with 21.4% compared to the Rockall cohort 24.0 and 53.2%, respectively (p < 0.001). This study shows that OTSC is superior to standard care and FLET reduces significantly rebleeding and rebleeding-associated mortality in NVUGIB. For this reason, OTSC could be the treatment of choice as the first-line treatment as an alternative to standard hemostasis techniques in high-risk patients.