Hemospray® (hemostatic powder TC-325) as monotherapy for acute gastrointestinal bleeding: a multicenter prospective study

Apostolis Papaefthymiou; Nasar Aslam; Mohamed Hussein; Durayd Alzoubaidi; Seth A. Gross; Alvaro De La Serna; Ioannis Varbobitis; Tricia A. Hengehold; Miguel Fraile López; Jacobo Ortiz Fernández-Sordo; Johannes W. Rey; Bu Hayee; Edward J. Despott; Alberto Murino; Sulleman Moreea; Phil Boger; Jason M. Dunn; Inder Mainie; Daniel Mullady; Dayna Early; Melissa Latorre; Krish Ragunath; John T. Anderson; Pradeep Bhandari; Martin Goetz; Ralf Kiesslich; Emmanuel Coron; Enrique Rodríguez De Santiago; Tamas A. Gonda; Michael O'Donnell; Benjamin Norton; Andrea Telese; Roberto Simons-Linares; Rehan Haidry

Authors Apostolis Papaefthymiou, Nasar Aslam, Mohamed Hussein, Durayd Alzoubaidi, Seth A. Gross, Alvaro De La Serna, Ioannis Varbobitis, Tricia A. Hengehold, Miguel Fraile López, Jacobo Ortiz Fernández-Sordo, Johannes W. Rey, Bu Hayee, Edward J. Despott, Alberto Murino, Sulleman Moreea, Phil Boger, Jason M. Dunn, Inder Mainie, Daniel Mullady, Dayna Early, Melissa Latorre, Krish Ragunath, John T. Anderson, Pradeep Bhandari, Martin Goetz, Ralf Kiesslich, Emmanuel Coron, Enrique Rodríguez De Santiago, Tamas A. Gonda, Michael O'Donnell, Benjamin Norton, Andrea Telese, Roberto Simons-Linares, Rehan Haidry.

Abstract

Background Hemostatic powders are used as second-line treatment in acute gastrointestinal (GI) bleeding (AGIB). Increasing evidence supports the use of TC-325 as monotherapy in specific scenarios. This prospective, multicenter study evaluated the performance of TC-325 as monotherapy for AGIB.

Methods Eighteen centers across Europe and USA contributed to a registry between 2016 and 2022. Adults with AGIB were eligible, unless TC-325 was part of combined hemostasis. The primary endpoint was immediate hemostasis. Secondary outcomes were rebleeding and mortality. Associations with risk factors were investigated (statistical significance at P≤0.05).

Results One hundred ninety patients were included (age 51-81 years, male: female 2:1), with peptic ulcer (n=48), upper GI malignancy (n=79), post-endoscopic treatment hemorrhage (n=37), and lower GI lesions (n=26). The primary outcome was recorded in 96.3% (95% confidence interval [CI]: 92.6-98.5) with rebleeding in 17.4% (95%CI 11.9-24.1); 9.9% (95%CI 5.8-15.6) died within 7 days, and 21.7% (95%CI 15.6-28.9) within 30 days. Regarding peptic ulcer, immediate hemostasis was achieved in 88% (95%CI 75-95), while 26% (95%CI 13-43) rebled. Higher ASA score was associated with mortality (OR 23.5, 95%CI 1.60-345; P=0.02). Immediate hemostasis was achieved in 100% of cases with malignancy and post-intervention bleeding, with rebleeding in 17% and 3.1%, respectively. Twenty-six patients received TC-325 for lower GI bleeding, and in all but one the primary outcome was achieved.

Conclusions TC-325 monotherapy is safe and effective, especially in malignancy or postendoscopic intervention bleeding. In patients with peptic ulcer, it could be helpful when the primary treatment is unfeasible, as bridge to definite therapy.

Keywords Hemospray®, TC-325, endoscopy, upper gastrointestinal bleeding

Ann Gastroenterol 2024; 37 (4): 418-426