Hemostatic spray powder TC-325 for GI bleeding in a nationwide study: survival and predictors of failure via competing risks analysis - 17/09/19

Doi : 10.1016/j.gie.2019.06.008

Enrique Rodríguez de Santiago, MD, MSc ^1,^2,^⁎, Diego Burgos-Santamaría, MD, PhD ^1,^2,³, Leticia Pérez-Carazo, MD ⁴, Enric Brullet, MD ⁵, Lucía Ciriano, MD ⁶, Faust Riu Pons, MD ^7,⁸, Miguel Ángel de Jorge Turrión, MD ⁹, Susana Prados, MD ¹⁰, Daniel Pérez-Corte, MD ¹¹, Irene Becerro-Gonzalez, MD ^3,^12,¹³, Emma Martinez-Moneo, MD ¹⁴, Angel Barturen, MD ^14,¹⁵, Ignacio Fernández-Urién, MD ¹⁶, Antonio López-Serrano, MD ¹⁷, Carlos Ferre-Aracil, MD ¹⁸, María Lopez-Ibañez, MD ⁴, Carlos Carbonell, MD ⁴, Oscar Nogales, MD ⁴, Eva Martínez-Bauer, MD ⁵, Álvaro Terán Lantarón, MD ⁶, Giulia Pagano, MD ^7,⁸, Enrique Vázquez-Sequeiros, MD, PhD ^1,^2,³, Agustín Albillos, MD, PhD ^1,^2,³
TC-325 Collaboration Project, Endoscopy Group of the Spanish Association of Gastroenterology
Antonio Guerrero García, MD, Nadja Volpato, MD, Carlos Rodriguez-Escaja, MD, Francisco Javier García-Alonso, MD, Sergio Sevilla-Ribota, MD, Hector Miguel Marcos Prieto, MD, Carlos Miguel Chavarría-Herbozo, MD, Oscar Murcia, MD, Javier Aranda-Hernández, MD, Rodrigo Borobia, MD, Javier García Lledó, MD, Cecilio Santander, MD, PhD, David Coto, MD, Daniel Oyón, MD, Inmaculada Ortiz Polo, MD, Mariano González-Haba Ruíz, MD, Consuelo Froilán Torres, MD, Marina De Benito Sanz, MD, Beatriz Peñas, MD, Sofía Parejo, MD, Diego Juzgado, MD, Alberto Ibañez, MD

¹ Department of Gastroenterology and Hepatology, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Madrid, Spain
² Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain
³ Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain
⁴ Department of Gastroenterology and Hepatology, Endoscopy Unit, Hospital General Universitario Gregorio Marañón, Universidad Complutense de Madrid, Madrid, Spain
⁵ Endoscopy Unit, Hospital Universitario Parc Taulí, Sabadell, Barcelona, Spain
⁶ Department of Gastroenterology and Hepatology, Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain
⁷ Department of Gastroenterology, Endoscopy Unit, Hospital del Mar, Barcelona, Spain
⁸ IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain
⁹ Digestive Service, Hospital de Cabueñes, Gijón, Spain
¹⁰ Department of Endoscopy, Hospital Universitario HM Sanchinarro, Madrid, Spain
¹¹ Department of Gastroenterology, Hospital de Avilés, Asturias, Spain
¹² Department of Gastroenterology and Hepatology, Hospital Universitario de La Princesa, Madrid, Spain
¹³ Instituto de Investigación Sanitaria Princesa (IIS-IP), Madrid, Spain
¹⁴ Gastroenterology Service, Hospital Universitario de Cruces, Baracaldo-Vizcaya, Spain
¹⁵ Department of Gastroenterology, Clínica IMQ Zorrotzaurre, Bilbao, Spain
¹⁶ Department of Gastroenterology and Hepatology, Complejo Hospitalario de Navarra, Pamplona, Spain
¹⁷ Department of Gastroenterology, Hospital Universitari Doctor Peset, Universidat de Valencia, Valencia, Spain
¹⁸ Department of Gastroenterology and Hepatology, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain

^∗Reprint requests: Enrique Rodríguez de Santiago. Department of Gastroenterology and Hepatology, Hospital Universitario Ramón y Cajal, Carretera de Colmenar Viejo Km 9.100, 28034 Madrid, Spain.Department of Gastroenterology and HepatologyHospital Universitario Ramón y CajalCarretera de Colmenar Viejo Km 9.100Madrid28034Spain

Abstract

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.

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Graphical abstract

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Abbreviations : ASA, CI, GIB, INR, RCT, sHR

Plan

Introduction

Methods

Study design

Study definitions and outcomes

Intraprocedural hemostasis

Recurrent bleeding and TC-325 failure

Adverse events

Survival

Discussion

	TC-325 Collaboration Project, Endoscopy Group of the Spanish Association of Gastroenterology
	Antonio Guerrero García, MD,^1,2,3 Nadja Volpato, MD,⁹ Carlos Rodriguez-Escaja, MD,²⁰ Francisco Javier García-Alonso, MD,²¹ Sergio Sevilla-Ribota, MD,²² Hector Miguel Marcos Prieto, MD,²³ Carlos Miguel Chavarría-Herbozo, MD,²⁴ Oscar Murcia, MD,²⁵ Javier Aranda-Hernández, MD,⁴ Rodrigo Borobia, MD,⁴ Javier García Lledó, MD,⁴ Cecilio Santander, MD, PhD,^3,12,13 David Coto, MD,¹⁴ Daniel Oyón, MD,¹⁶ Inmaculada Ortiz Polo, MD,¹⁷ Mariano González-Haba Ruíz, MD,¹⁸ Consuelo Froilán Torres, MD,¹⁹ Marina De Benito Sanz, MD,²¹ Beatriz Peñas, MD,^1,2,3 Sofía Parejo, MD,^1,2,3 Diego Juzgado, MD,²² Alberto Ibañez, MD²⁴
	Digestive Service, Hospital Universitario La Paz, Madrid (19); Department of Gastroenterology and Hepatology, Hospital Universitario Central de Asturias, Oviedo (20); Department of Gastroenterology and Hepatology, Hospital Universitario Río Hortega, Valladolid (21); Digestive Service, Hospital Universitario Quirón, Madrid (22); Department of Gastroenterology and Hepatology, Complejo Asistencial Universitario de Salamanca, IBSAL, Salamanca (23); Department of Gastroenterology, Hospital Universitario del Henares, Coslada, Madrid (24); Endoscopy Unit, Hospital Santa Ana de Motril, Granada, Spain (25).
	If you would like to chat with an author of this article, you may contact Dr Rodríguez de Santiago at [email protected].
	DISCLOSURE: Dr. Vazquez-Sequeiros has received financial support from Olympus and Boston Scientific for lectures and consultancy tasks. All other authors disclosed no financial relationships relevant to this publication.

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Vol 90 - N° 4

P. 581 - octobre 2019 Retour au numéro

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Hemostatic spray powder TC-325 for GI bleeding in a nationwide study: survival and predictors of failure via competing risks analysis - 17/09/19

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Graphical abstract

Plan

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