Preliminary results from RCT study show that OTSC first-line treatment is superior to standard treatment for acute non-varicose upper GI bleeding with high risk of rebleeding
The 50th Conference of the German Society for Endoscopy and Imaging Procedures (DGE-BV) took place on April 8 – 10, 2021. Subject of the Symposium on April 8th was telemetric haemorrhage detection with the HemoPill® acute followed by two presentations on hemostasis with the OTSC® System. Here you can find the summary of the presentation by Prof. Caca. To rewatch the symposium (in German only) please click here: https://ovesco.com/de/dge-bv-symposium-2021/
Prof. Dr. Karel Caca, Ludwigsburg: Primary haemostasis with the OTSC System is highly effective
Prof. K. Caca, Ludwigsburg, presented preliminary data on the RCT he coordinated (STING II) on the use of the OTSC System in severe, non-varicose upper GI bleeding. Despite good treatment options, the mortality of upper GI bleeding is still relatively high at 5–10%, especially in older and comorbid patients. Endoscopy is primarily successful in approx. 90% of cases with the current standard procedures, but the application of endoclips can be difficult, especially with a hard ulcer surface. In the treatment of recurrent bleeding, OTSC has become established due to the significantly lower rebleeding rates compared to standard treatment (STING study). STING II was subsequently initiated to investigate whether OTSC treatment is superior to standard treatment also in acute, non-varicose upper GI bleeding with a high risk of rebleeding (“complete Rockall score” ≥ 7 points). Standard treatment consisted of at least 2 conventional clips or thermal procedure plus adrenaline injection. OTSC treatment consisted of primary OTSC application (injection was allowed). According to the calculation of the number of cases (power 80%), n = 100 patients with endoscopically confirmed acute (non-varicose) upper GI bleeding and a “complete Rockall score” ≥ 7 points were included. Exclusion criteria included prior endoscopic treatment within the last 4 weeks to rule out treatment of recurrent bleeding.
The primary endpoint was successful haemostasis without recurrent bleeding within 7 days. Secondary endpoints were the need for second-line treatment, need for transfusion, hospitalisation duration, ICU stay and 30-day mortality.
After randomisation, n = 52 patients could be evaluated in the standard arm and n = 48 patients in the OTSC arm. Both groups show good correspondence to the baseline. 42.3% of patients in the standard arm and 39.6% in the OTSC arm were on anticoagulation or platelet aggregation inhibition. The median age of patients was 79 years (51–96) in the standard arm and 78 years (42–92) in the OTSC arm. The median Rockall score was 8 points in both groups, and the predominant localisation was in the duodenum (46.1% standard vs. 60.4% OTSC). Mainly peptic ulcer bleeding was present with approx. 95% in both arms. Further details can be found in the video (presentation from 32:30 min).
Preliminary analysis of the data shows that the OTSC System is significantly superior (p = 0.019) to standard treatment at 91.7% (44/48) to 73.1% (38/52) in successful haemostasis (no rebleeding or persistent bleeding within 7 days). There was no persistent bleeding with the OTSC compared with 6 (11.5%) persistent bleeding in the standard arm (p = 0.027). All persistent bleeding in the standard arm could be successfully stopped with OTSC. In the OTSC, 8.3% (4/48) of rebleeds occurred within 7 days compared with 15.4% (8/52) in the standard arm (p = 0.362). The treatment time was comparable at 27 min (OTSC) and 28 min. Late rebleeding (day 8–30) occurred in 2 cases (4.2%) with OTSC versus none in the standard treatment arm (p = 0.028). This resulted in a total bleeding rate (incl. persistent bleeding) of 12.5% (6/48) with OTSC and 26.9% (14/52) with standard treatment (p = 0.084). There were no significant differences with regard to the other endpoints (blood transfusion, ICU stay, length of hospitalisation, mortality and need for second-line treatment).
Prof. Caca summarised that OTSC is superior to standard treatment for acute non-varicose upper GI bleeding with a high risk of rebleeding and that primary haemostasis by OTSC is highly effective (no persistent bleeding in the OTSC arm). Furthermore, no additional time was required for OTSC treatment. The study is currently the largest RCT study regarding the first-line treatment of upper GI bleeding with the OTSC System. However, it should be noted that the data is currently still preliminary and not published.
STING II – randomised controlled data on first-line treatment of severe upper GI bleeding with the OTSC® System
K. Caca, Klinikum Ludwigsburg, Ludwigsburg
Symposium presentation at the virtuell DGE-BV congress 2021