Hemostatic spray powder TC-325 for GI bleeding in a nationwide study: survival and predictors of failure via competing risks analysis
Por:
Rodríguez de Santiago E, Burgos-Santamaria D, Pérez-Carazo L, Brullet E, Ciriano L, Pons FR, Ángel de Jorge Turrión M, Prados S, Pérez-Corte D, Becerro-Gonzalez I, Martinez-Moneo E, Barturen A, Fernández-Urién I, López-Serrano A, Ferre-Aracil C, Lopez-Ibañez M, Carbonell C, Nogales O, Martínez-Bauer E, Lantarón ÁT, Pagano G, Vázquez-Sequeiros E, Albillos A, García AG, Volpato N, Rodriguez-Escaja C, García-Alonso FJ, Sevilla-Ribota S, Marcos Prieto HM, Chavarría-Herbozo CM, Murcia O, Aranda-Hernández J, Borobia R, Lledó JG, Santander C, Coto D, Oyón D, Polo IO, González-Haba Ruíz M, Torres CF, De Benito Sanz M, Peñas B, Parejo S, Juzgado D and Ibañez A
Publicada:
1 oct 2019
Ahead of Print:
17 jun 2019
Resumen:
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 pepticulcer (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.
Filiaciones:
Rodríguez de Santiago E:
Dept. of Gastroenterology and Hepatology, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Madrid, Spain
Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain
Burgos-Santamaria D:
Dept. of Gastroenterology and Hepatology, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Madrid, Spain
Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain
Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain
Pérez-Carazo L:
Dept. of Gastroenterology and Hepatology, Endoscopy Unit, Hospital General Universitario Gregorio Marañón, Universidad Complutense de Madrid, Madrid, Spain
Brullet E:
Endoscopy Unit, Hospital Universitario Parc Taulí, Sabadell, Barcelona, Spain
Ciriano L:
Dept. of Gastroenterology and Hepatology, Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain
Pons FR:
Dept. of Gatroenterology, Endoscopy Unit, Hospital del Mar, Barcelona, Spain
IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain
Ángel de Jorge Turrión M:
Digestive Service, Hospital de Cabueñes, Gijón, Spain
Prados S:
Dept. of Endoscopy, Hospital Universitario HM Sanchinarro, Madrid, Spain
Pérez-Corte D:
Dept. of Gastroenterology, Hospital de Avilés, Asturias, Spain
Becerro-Gonzalez I:
Dept. of Gastroenterology and Hepatology, Hospital Universitario de La Princesa, Madrid, Spain
Instituto de Investigació
n Sanitaria Princesa (IIS-IP)
Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain
Martinez-Moneo E:
Gastroenterology Service, Hospital Universitario de Cruces, Baracaldo-Vizcaya, Spain
Barturen A:
Gastroenterology Service, Hospital Universitario de Cruces, Baracaldo-Vizcaya, Spain
Dept. of Gastroenterology, Clínica IMQ Zorrotzaurre, Vizcaya, Spain
Fernández-Urién I:
Dept. of Gastroenterology and Hepatology, Complejo Hospitalario de Navarra, Pamplona, Spain
:
Dept. of Gastroenterology, Hospital Universitari Doctor Peset, Universidat de Valencia, Valencia, Spain
Ferre-Aracil C:
Dept. of Gastroenterology and Hepatology, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain
Lopez-Ibañez M:
Dept. of Gastroenterology and Hepatology, Endoscopy Unit, Hospital General Universitario Gregorio Marañón, Universidad Complutense de Madrid, Madrid, Spain
Carbonell C:
Dept. of Gastroenterology and Hepatology, Endoscopy Unit, Hospital General Universitario Gregorio Marañón, Universidad Complutense de Madrid, Madrid, Spain
Nogales O:
Dept. of Gastroenterology and Hepatology, Endoscopy Unit, Hospital General Universitario Gregorio Marañón, Universidad Complutense de Madrid, Madrid, Spain
Martínez-Bauer E:
Endoscopy Unit, Hospital Universitario Parc Taulí, Sabadell, Barcelona, Spain
Lantarón ÁT:
Dept. of Gastroenterology and Hepatology, Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain
Pagano G:
Dept. of Gatroenterology, Endoscopy Unit, Hospital del Mar, Barcelona, Spain
IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain
Vázquez-Sequeiros E:
Dept. of Gastroenterology and Hepatology, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Madrid, Spain
Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain
Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain
Albillos A:
Dept. of Gastroenterology and Hepatology, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Madrid, Spain
Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain
Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain
García AG:
Dept. of Gastroenterology and Hepatology, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Madrid, Spain
Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain
Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain
Volpato N:
Digestive Service, Hospital Universitario La Paz, Madrid, Spain
Rodriguez-Escaja C:
Dept. of Gastroenterology and Hepatology, Hospital Universitario Central de Asturias, Oviedo, Spain
García-Alonso FJ:
Dept. of Gastroenterology and Hepatology, Hospital Universitario Río Hortega, Valladolid, Spain
Sevilla-Ribota S:
Digestive Service, Hospital Universitario Quirón, Madrid
Marcos Prieto HM:
Dept. of Gastroenterology and Hepatology, Complejo Asistencial Universitario de Salamanca, IBSAL, Salamanca, Spain
Chavarría-Herbozo CM:
Dept. of Gastroenterology, Hospital Universitario del Henares, Coslada, Madrid, Spain
Murcia O:
Endoscopy Unit, Hospital General de Motril, Granada, Spain
Aranda-Hernández J:
Dept. of Gastroenterology and Hepatology, Endoscopy Unit, Hospital General Universitario Gregorio Marañón, Universidad Complutense de Madrid, Madrid, Spain
Borobia R:
Dept. of Gastroenterology and Hepatology, Endoscopy Unit, Hospital General Universitario Gregorio Marañón, Universidad Complutense de Madrid, Madrid, Spain
Lledó JG:
Dept. of Gastroenterology and Hepatology, Endoscopy Unit, Hospital General Universitario Gregorio Marañón, Universidad Complutense de Madrid, Madrid, Spain
Santander C:
Dept. of Gastroenterology and Hepatology, Hospital Universitario de La Princesa, Madrid, Spain
Instituto de Investigació
n Sanitaria Princesa (IIS-IP)
Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain
Coto D:
Gastroenterology Service, Hospital Universitario de Cruces, Baracaldo-Vizcaya, Spain
Oyón D:
Dept. of Gastroenterology and Hepatology, Complejo Hospitalario de Navarra, Pamplona, Spain
:
Dept. of Gastroenterology, Hospital Universitari Doctor Peset, Universidat de Valencia, Valencia, Spain
González-Haba Ruíz M:
Dept. of Gastroenterology and Hepatology, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain
Torres CF:
Digestive Service, Hospital Universitario La Paz, Madrid, Spain
De Benito Sanz M:
Dept. of Gastroenterology and Hepatology, Hospital Universitario Río Hortega, Valladolid, Spain
Peñas B:
Dept. of Gastroenterology and Hepatology, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Madrid, Spain
Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain
Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain
Parejo S:
Dept. of Gastroenterology and Hepatology, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Madrid, Spain
Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain
Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain
Juzgado D:
Digestive Service, Hospital Universitario Quirón, Madrid
Ibañez A:
Dept. of Gastroenterology, Hospital Universitario del Henares, Coslada, Madrid, Spain
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