Beatriz Peñas, Inmaculada Ortiz Polo, Enrique Vazquez-Sequeiros, Antonio Guerrero García, Carlos Miguel Chavarría-Herbozo, Agustín Albillos, Enrique Rodríguez de Santiago, Carlos Ferre-Aracil, Emma Martinez-Moneo, Mariano Gonzalez-Haba Ruiz, Consuelo Froilán Torres, Lucía Ciriano, Sofía Parejo, Óscar Nogales, Miguel Ángel de Jorge Turrión, Rodrigo Borobia, Carlos Carbonell, Sergio Sevilla-Ribota, Giulia Pagano, Susana Prados, María López-Ibáñez, Irene Becerro-Gonzalez, Faust Riu Pons, Marina de Benito Sanz, Diego Burgos-Santamaría, Diego Juzgado, Daniel Oyón, Nadja Volpato, Leticia Pérez-Carazo, Eva Martínez-Bauer, Cecilio Santander, Oscar Murcia, Alberto Ibañez, Enric Brullet, Antonio López-Serrano, Daniel Pérez-Corte, Javier Aranda-Hernández, David Coto, Carlos Rodríguez-Escaja, Héctor Miguel Marcos Prieto, Javier García Lledó, Francisco Javier García-Alonso, Angel Barturen, Ignacio Fernandez-Urien, and Álvaro Terán Lantarón
Background and Aims TC-325 (Hemospray, Cook Medical, Winston-Salem, NC) is an inorganic hemostatic powder recently approved by the U.S. Food and Drug Administration. This study aimed to examine the effectiveness, safety, and predictors of TC-325 failure in a large real-life cohort. Methods This was a retrospective study conducted at 21 Spanish centers. All patients treated with TC-325 until September 2018 were included. The primary outcome was treatment failure, defined as failed intraprocedural hemostasis or recurrent bleeding within the first 30 postprocedural days. Secondary outcomes included safety and survival. Risk and predictors of failure were assessed via competing-risk models. Results The cohort comprised 261 patients, of whom 219 (83.9%) presented with upper gastrointestinal bleeding (GIB). The most common causes were peptic ulcer (28%), malignancy (18.4%), and therapeutic endoscopy-related GIB (17.6%). TC-325 was used as rescue therapy in 191 (73.2%) patients. The rate of intraprocedural hemostasis was 93.5% (95% confidence interval [CI], 90%-96%). Risks of TC-325 failure at postprocedural days 3, 7, and 30 were 21.1%, 24.6%, and 27.4%, respectively. On multivariate analysis, spurting bleeding (P = .004), use of vasoactive drugs (P = .02), and hypotension (P = .008) were independent predictors of failure. Overall 30-day survival was 81.9% (95% CI, 76%-86%) and intraprocedural hemostasis was associated with a better prognosis (adjusted hazard ratio, 0.29; P = .006). Two severe adverse events were noted. Conclusion TC-325 was safe and effective for intraprocedural hemostasis in more than 90% of patients, regardless of the cause or site of bleeding and its use as rescue therapy. In this high-risk cohort treated with TC-325, the 30-day failure rate exceeded 25% and was highest with spurting bleeding or hemodynamic instability.