TY - JOUR

T1 - Effects of Early Placement of Transjugular Portosystemic Shunts in Patients With High-Risk Acute Variceal Bleeding

T2 - a Meta-analysis of Individual Patient Data

AU - Nicoară-Farcău, Oana

AU - Han, Guohong

AU - Rudler, Marika

AU - Angrisani, Debora

AU - Monescillo, Alberto

AU - Torres, Ferran

AU - Casanovas, Georgina

AU - Bosch, Jaime

AU - Lv, Yong

AU - Thabut, Dominique

AU - Fan, Daiming

AU - Hernández-Gea, Virginia

AU - García-Pagán, Juan Carlos

AU - Bureau, Christophe

AU - Abraldes, Juan G.

AU - Nevens, Frederik

AU - Caca, Karel

AU - Laleman, Wim

AU - Appenrodt, Beate

AU - Luca, Angelo

AU - Vinel, Jean Pierre

AU - Mössner, Joachim

AU - Di Pascoli, Marco

AU - Zipprich, Alexander

AU - Sauerbruch, Tilman

AU - Martinez-Lagares, Francisco

AU - Ruiz-del-Arbol, Luis

AU - Sierra, Angel

AU - Guevara, Clemencia

AU - Jimenez, Elena

AU - Marrero, Jose Miguel

AU - Buceta, Enrique

AU - Sanchez, Juan

AU - Castellot, Ana

AU - Penate, Monica

AU - Cruz, Ana

AU - Pena, Elena

AU - Procopeț, Bogdan

AU - Giráldez, Álvaro

AU - Amitrano, Lucio

AU - Villanueva, Candid

AU - Ibañez-Samaniego, Luis

AU - Silva-Junior, Gilberto

AU - Martinez, Javier

AU - Genescà, Joan

AU - Trebicka, Jonel

AU - Llop, Elba

AU - Palazon, Jose Maria

AU - Gluud, Lise L.

AU - Krag, Aleksander

AU - Preemptive TIPS Individual Data Metanalysis, International Variceal Bleeding Study and Baveno Cooperation Study groups

N1 - Funding Information: Funding Juan Carlos Garc?a-Pag?n received support in part through grants from the Spanish Ministry of Education and Science (SAF-2016?75767-R and PIE 15/00027) and from the ?Commissioner for Universities and Research of the Generalitat de Catalunya? (AGAUR SGR 2017). CIBERehd is funded by the Instituto de Salud Carlos III. Edilmar Alvarado-Tapias and Anna Baiges are recipients of a ?R?o Hortega? fellowship grant from the Instituto de Salud Carlos III. The study was partially supported by a GORE grant for statistical support. Conflict of interest Jaime Bosch has received speaker fees from Gore; and served as a consultant for Actelion, Ambys, BioVie, Brudy, BMS, BLB, Chiasma, Exalenz, Lipocine, and Surrozen. Virginia Hern?ndez-Gea has received consultant fees from Gore. Juan Carlos Garc?a-Pag?n has received consultant fees from Shionogi and research grants from Novartis and Gore. Christophe Bureau has received speaker fees from GORE and is a board member in Alfawassemran/Norgine. Alvaro Giraldez, Agustin Albillos, Dominique Thabut, Jonel Trebicka, and Frederik Nevens have received speaker fees from GORE. The other authors disclose no conflicts. Funding Information: Funding Juan Carlos García-Pagán received support in part through grants from the Spanish Ministry of Education and Science (SAF-2016–75767-R and PIE 15/00027) and from the “Commissioner for Universities and Research of the Generalitat de Catalunya” (AGAUR SGR 2017). CIBERehd is funded by the Instituto de Salud Carlos III . Edilmar Alvarado-Tapias and Anna Baiges are recipients of a "Río Hortega" fellowship grant from the Instituto de Salud Carlos III . The study was partially supported by a GORE grant for statistical support. Funding Information: Conflict of interest Jaime Bosch has received speaker fees from Gore; and served as a consultant for Actelion, Ambys, BioVie, Brudy, BMS, BLB, Chiasma, Exalenz, Lipocine, and Surrozen. Virginia Hernández-Gea has received consultant fees from Gore. Juan Carlos García-Pagán has received consultant fees from Shionogi and research grants from Novartis and Gore. Christophe Bureau has received speaker fees from GORE and is a board member in Alfawassemran/Norgine. Alvaro Giraldez, Agustin Albillos, Dominique Thabut, Jonel Trebicka, and Frederik Nevens have received speaker fees from GORE. The other authors disclose no conflicts. Publisher Copyright: © 2021 AGA Institute

PY - 2021

Y1 - 2021

N2 - Background & Aims: Compared with drugs plus endoscopy, placement of transjugular portosystemic shunt within 72 hours of admission to the hospital (early or preventive transjugular intrahepatic portosystemic shunt [TIPS], also called preemptive TIPS) increases the proportion of high-risk patients with cirrhosis and acute variceal bleeding who survive for 1 year. However, the benefit of preemptive TIPS is less clear for patients with a Child-Pugh score of B and active bleeding (CP-B+AB). We performed an individual data meta-analysis to assess the efficacy of preemptive TIPS in these patients and identify factors associated with reduced survival of patients receiving preemptive TIPS. Methods: We searched publication databases for randomized controlled trials and observational studies comparing the effects of preemptive TIPS versus endoscopy plus nonselective beta-blockers in the specific population of high-risk patients with cirrhosis and acute variceal bleeding (CP-B+AB or Child-Pugh C, below 14 points), through December 31, 2019. We performed a meta-analysis of data from 7 studies (3 randomized controlled trials and 4 observational studies), comprising 1327 patients (310 received preemptive TIPS and 1017 received drugs plus endoscopy). We built adjusted models to evaluate risk using propensity score for baseline covariates. Multivariate Cox regression models were used to assess the factors associated with survival time. The primary endpoint was effects of preemptive TIPS versus drugs plus endoscopy on 1-year survival in the overall population as well as CP-B+AB and Child-Pugh C patients. Results: Overall, preemptive TIPS significantly increased the proportion of high-risk patients with cirrhosis and acute variceal bleeding who survived for 1 year, compared with drugs plus endoscopy (hazard ratio [HR] 0.443; 95% CI 0.323–0.607; P < .001). This effect was observed in CP-B+AB patients (HR 0.524; 95% CI 0.307–0.896; P = .018) and in patients with Child-Pugh C scores below 14 points (HR 0.374; 95% CI 0.253–0.553; P < .001). Preemptive TIPS significantly improved control of bleeding and ascites without increasing risk of hepatic encephalopathy in Child-Pugh C and CP-B+AB patients, compared with drugs plus endoscopy. Cox analysis of patients who received preemptive TIPS showed that patients could be classified into 3 categories for risk of death, based on age, serum level of creatinine, and Child-Pugh score. In each of these risk categories, preemptive TIPS increased the proportion of patients who survived for 1 year, compared with drugs plus endoscopy. Conclusions: In a meta-analysis of data from 1327 patients with cirrhosis, acute variceal bleeding, and Child-Pugh score between 10 and 13 points or CP-B+AB, preemptive TIPS increased the proportion who survived for 1 year, in both subgroups separately, compared with drugs plus endoscopy.

AB - Background & Aims: Compared with drugs plus endoscopy, placement of transjugular portosystemic shunt within 72 hours of admission to the hospital (early or preventive transjugular intrahepatic portosystemic shunt [TIPS], also called preemptive TIPS) increases the proportion of high-risk patients with cirrhosis and acute variceal bleeding who survive for 1 year. However, the benefit of preemptive TIPS is less clear for patients with a Child-Pugh score of B and active bleeding (CP-B+AB). We performed an individual data meta-analysis to assess the efficacy of preemptive TIPS in these patients and identify factors associated with reduced survival of patients receiving preemptive TIPS. Methods: We searched publication databases for randomized controlled trials and observational studies comparing the effects of preemptive TIPS versus endoscopy plus nonselective beta-blockers in the specific population of high-risk patients with cirrhosis and acute variceal bleeding (CP-B+AB or Child-Pugh C, below 14 points), through December 31, 2019. We performed a meta-analysis of data from 7 studies (3 randomized controlled trials and 4 observational studies), comprising 1327 patients (310 received preemptive TIPS and 1017 received drugs plus endoscopy). We built adjusted models to evaluate risk using propensity score for baseline covariates. Multivariate Cox regression models were used to assess the factors associated with survival time. The primary endpoint was effects of preemptive TIPS versus drugs plus endoscopy on 1-year survival in the overall population as well as CP-B+AB and Child-Pugh C patients. Results: Overall, preemptive TIPS significantly increased the proportion of high-risk patients with cirrhosis and acute variceal bleeding who survived for 1 year, compared with drugs plus endoscopy (hazard ratio [HR] 0.443; 95% CI 0.323–0.607; P < .001). This effect was observed in CP-B+AB patients (HR 0.524; 95% CI 0.307–0.896; P = .018) and in patients with Child-Pugh C scores below 14 points (HR 0.374; 95% CI 0.253–0.553; P < .001). Preemptive TIPS significantly improved control of bleeding and ascites without increasing risk of hepatic encephalopathy in Child-Pugh C and CP-B+AB patients, compared with drugs plus endoscopy. Cox analysis of patients who received preemptive TIPS showed that patients could be classified into 3 categories for risk of death, based on age, serum level of creatinine, and Child-Pugh score. In each of these risk categories, preemptive TIPS increased the proportion of patients who survived for 1 year, compared with drugs plus endoscopy. Conclusions: In a meta-analysis of data from 1327 patients with cirrhosis, acute variceal bleeding, and Child-Pugh score between 10 and 13 points or CP-B+AB, preemptive TIPS increased the proportion who survived for 1 year, in both subgroups separately, compared with drugs plus endoscopy.

KW - AVB

KW - HE

KW - Liver Disease

KW - Treatment

U2 - 10.1053/j.gastro.2020.09.026

DO - 10.1053/j.gastro.2020.09.026

M3 - Journal article

C2 - 32980344

AN - SCOPUS:85097664689

VL - 160

SP - 193

EP - 205

JO - Gastroenterology

JF - Gastroenterology

SN - 0016-5085

IS - 1

ER -