Does preemptive transjugular intrahepatic portosystemic shunt improve survival after acute variceal bleeding? Systematic review, meta-analysis, and trial sequential analysis of randomized trials.
6-week mortality
Acute variceal bleeding
Cirrhosis
Meta-analysis
Preemptive transjugular intrahepatic portosystemic shunt
Trial sequential analysis
Journal
Journal of gastroenterology and hepatology
ISSN: 1440-1746
Titre abrégé: J Gastroenterol Hepatol
Pays: Australia
ID NLM: 8607909
Informations de publication
Date de publication:
Mar 2022
Mar 2022
Historique:
revised:
20
09
2021
received:
10
07
2021
accepted:
12
10
2021
pubmed:
20
10
2021
medline:
29
3
2022
entrez:
19
10
2021
Statut:
ppublish
Résumé
A preemptive transjugular intrahepatic portosystemic shunt (p-TIPSS) after acute variceal bleeding (AVB) is advocated. However, when compared with the current standard of care, the survival benefit of p-TIPSS is questionable. We performed a systematic review, meta-analysis, and trial sequential analysis of randomized control trials (RCTs) to assess the survival benefit of p-TIPSS in patients with cirrhosis and AVB. Comprehensive literature search of three bibliographic databases (MEDLINE, Embase, and Cochrane) was conducted from inception till May 2021. All study types evaluating the survival benefit of p-TIPSS in AVB were considered for inclusion. The relative risk (RR) of mortality and rebleeding at 6 weeks and mortality at 1 year with a random-effects model was computed. Trial sequential analysis was performed for the primary outcome of 6-week mortality. A total of nine studies (four RCTs and five cohort studies) comprising 2861 patients with AVB were included. The overall pooled risks of mortality at 6 weeks and 1 year were 17.9% (95% confidence interval [CI]: 16.5-19.3%) and 26.7% (95% CI: 25.0-28.3%), respectively. Although p-TIPSS was associated with lower 6-week rebleeding risk (RR = 0.20; 95% CI = 0.13-0.29, I This meta-analysis found that the available data from RCTs are insufficient to confer 6-week mortality benefit with p-TIPSS compared with standard of care; thus, adequately powered RCTs are required.
Sections du résumé
BACKGROUND AND AIM
OBJECTIVE
A preemptive transjugular intrahepatic portosystemic shunt (p-TIPSS) after acute variceal bleeding (AVB) is advocated. However, when compared with the current standard of care, the survival benefit of p-TIPSS is questionable. We performed a systematic review, meta-analysis, and trial sequential analysis of randomized control trials (RCTs) to assess the survival benefit of p-TIPSS in patients with cirrhosis and AVB.
METHODS
METHODS
Comprehensive literature search of three bibliographic databases (MEDLINE, Embase, and Cochrane) was conducted from inception till May 2021. All study types evaluating the survival benefit of p-TIPSS in AVB were considered for inclusion. The relative risk (RR) of mortality and rebleeding at 6 weeks and mortality at 1 year with a random-effects model was computed. Trial sequential analysis was performed for the primary outcome of 6-week mortality.
RESULTS
RESULTS
A total of nine studies (four RCTs and five cohort studies) comprising 2861 patients with AVB were included. The overall pooled risks of mortality at 6 weeks and 1 year were 17.9% (95% confidence interval [CI]: 16.5-19.3%) and 26.7% (95% CI: 25.0-28.3%), respectively. Although p-TIPSS was associated with lower 6-week rebleeding risk (RR = 0.20; 95% CI = 0.13-0.29, I
CONCLUSIONS
CONCLUSIONS
This meta-analysis found that the available data from RCTs are insufficient to confer 6-week mortality benefit with p-TIPSS compared with standard of care; thus, adequately powered RCTs are required.
Types de publication
Journal Article
Meta-Analysis
Systematic Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
455-463Informations de copyright
© 2021 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.
Références
Garcia-Tsao G, Bosch J. Management of varices and variceal hemorrhage in cirrhosis. N. Engl. J. Med. 2010; 362: 823-832.
Bosch J. Portal hypertension and cirrhosis: from evolving concepts to better therapies. Clin. Liver Dis. 2020; 15: S8-S12.
Roberts D, Best LM, Freeman SC et al. Treatment for bleeding oesophageal varices in people with decompensated liver cirrhosis: a network meta-analysis. Cochrane Database Syst. Rev. 2021; 4: CD013155.
de Franchis R, Baveno VI Faculty. Expanding consensus in portal hypertension: report of the Baveno VI Consensus Workshop: stratifying risk and individualizing care for portal hypertension. J. Hepatol. 2015; 63: 743-752.
Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the Study of Liver Diseases. Hepatology 2017; 65: 310-335.
Tripathi D, Stanley AJ, Hayes PC et al. UK guidelines on the management of variceal haemorrhage in cirrhotic patients. Gut 2015; 64: 1680-1704.
Angeli P, Bernardi M, Villanueva C et al. EASL Clinical Practice Guidelines for the management of patients with decompensated cirrhosis. J. Hepatol. 2018; 69: 406-460.
Azoulay D, Castaing D, Majno P et al. Salvage transjugular intrahepatic portosystemic shunt for uncontrolled variceal bleeding in patients with decompensated cirrhosis. J. Hepatol. 2001; 35: 590-597.
Augustin S, Altamirano J, González A et al. Effectiveness of combined pharmacologic and ligation therapy in high-risk patients with acute esophageal variceal bleeding. Am. J. Gastroenterol. 2011; 106: 1787-1795.
Tripathi D, Stanley AJ, Hayes PC et al. Transjugular intrahepatic portosystemic stent-shunt in the management of portal hypertension. Gut 2020; 69: 1173-1192.
García-Pagán JC, Caca K, Bureau C et al. Early use of TIPS in patients with cirrhosis and variceal bleeding. N. Engl. J. Med. 2010; 362: 2370-2379.
Dunne PDJ, Sinha R, Stanley AJ et al. Randomised clinical trial: standard of care versus early-transjugular intrahepatic porto-systemic shunt (TIPSS) in patients with cirrhosis and oesophageal variceal bleeding. Aliment. Pharmacol. Ther. 2020; 52: 98-106.
Hernandez-Gea V, Procopet B, Giraldez A et al. Preemptive-TIPS improves outcome in high-risk variceal bleeding: an observational study. Hepatology 2019; 69: 282-293.
Thabut D, Pauwels A, Carbonell N et al. Cirrhotic patients with portal hypertension-related bleeding and an indication for early-TIPS: a large multicentre audit with real-life results. J. Hepatol. 2018; 68: 73-81.
Wetterslev J, Thorlund K, Brok J, Gluud C. Trial sequential analysis may establish when firm evidence is reached in cumulative meta-analysis. J. Clin. Epidemiol. 2008; 61: 64-75.
Thorlund K, Engstrøm J, Wetterslev J, Brok J, Imberger G, Gluud C. User Manual for Trial Sequential Analysis (TSA). Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen, Denmark. 2011;1-115. Available from www.ctu.dk/tsa
Julian P.T. Higgins, James Thomas, Jacqueline Chandler, Miranda Cumpston, Tianjing Li, Matthew J. Page, Vivian A. Welch. Cochrane Handbook for Systematic Reviews of Interventions. Wiley; 2019. https://doi.org/10.1002/9781119536604
Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred Reporting Items for Systematic Reviews and Meta-Analyses: the PRISMA statement. Ann. Intern. Med. 2009; 151: 264-269.
Shea BJ, Reeves BC, Wells G et al. AMSTAR 2: a critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both. BMJ 2017; 358: j4008.
Stang A. Critical evaluation of the Newcastle-Ottawa scale for the assessment of the quality of nonrandomized studies in meta-analyses. Eur. J. Epidemiol. 2010; 25: 603-605.
Higgins JPT, Altman DG, Gøtzsche PC et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ 2011; 343: 1-9.
Riley RD, Higgins JPT, Deeks JJ. Interpretation of random effects meta-analyses. BMJ 2011; 342: d549.
DerSimonian R, Laird N. Meta-analysis in clinical trials. Control. Clin. Trials 1986; 7: 177-188.
Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. Br. Med. J. 2003; 327: 557-560.
de Franchis R, Baveno V Faculty. Revising consensus in portal hypertension: report of the Baveno V consensus workshop on methodology of diagnosis and therapy in portal hypertension. J. Hepatol. 2010; 53: 762-768.
Monescillo A, Martinez-Lagares F, Ruiz-del-Arbol L et al. Influence of portal hypertension and its early decompression by TIPS placement on the outcome of variceal bleeding. Hepatology 2004; 40: 793-801.
Pulido J, Cabera J, Granados R et al. Transjugular intrahepatic portosystemic shunt versus slerotherapy in elective treatment of variceal hemorrhage: a randomized controlled trial. AJR Am. J. Roentgenol. 1996; 166: 87.
García-Villarreal L, Martínez-Lagares F, Sierra A et al. Transjugular intrahepatic portosystemic shunt versus endoscopic sclerotherapy for the prevention of variceal rebleeding after recent variceal hemorrhage. Hepatology 1999; 29: 27-32.
Lv Y, Yang Z, Liu L et al. Early TIPS with covered stents versus standard treatment for acute variceal bleeding in patients with advanced cirrhosis: a randomised controlled trial. Lancet Gastroenterol. Hepatol. 2019; 4: 587-598.
Garcia-Pagán JC, Di Pascoli M, Caca K et al. Use of early-TIPS for high-risk variceal bleeding: results of a post-RCT surveillance study. J. Hepatol. 2013; 58: 45-50.
Rudler M, Cluzel P, Corvec TL et al. Early-TIPSS placement prevents rebleeding in high-risk patients with variceal bleeding, without improving survival. Aliment. Pharmacol. Ther. 2014; 40: 1074-1080.
Lv Y, Zuo L, Zhu X et al. Identifying optimal candidates for early TIPS among patients with cirrhosis and acute variceal bleeding: a multicentre observational study. Gut 2019; 68: 1297-1310.
Deltenre P, Trépo E, Rudler M et al. Early transjugular intrahepatic portosystemic shunt in cirrhotic patients with acute variceal bleeding: a systematic review and meta-analysis of controlled trials. Eur. J. Gastroenterol. Hepatol. 2015; 27: e1-e9.
Halabi SA, Sawas T, Sadat B et al. Early TIPS versus endoscopic therapy for secondary prophylaxis after management of acute esophageal variceal bleeding in cirrhotic patients: a meta-analysis of randomized controlled trials. J. Gastroenterol. Hepatol. 2016; 31: 1519-1526.
Li S, Zhang C, Lin L-L et al. Early-TIPS versus current standard therapy for acute variceal bleeding in cirrhosis patients: a systemic review with meta-analysis. Front. Pharmacol. 2020; 11.
Nicoară-Farcău O, Han G, Rudler M et al. Effects of early placement of transjugular portosystemic shunts in patients with high-risk acute variceal bleeding: a meta-analysis of individual patient data. Gastroenterology 2021; 160: 193-205.e10.
Trebicka J, Gu W, Ibáñez-Samaniego L et al. Rebleeding and mortality risk are increased by ACLF but reduced by pre-emptive TIPS. J. Hepatol. 2020; 73: 1082-1091.
Perarnau JM, Le Gouge A, Nicolas C et al. Covered vs. uncovered stents for transjugular intrahepatic portosystemic shunt: a randomized controlled trial. J. Hepatol. 2014; 60: 962-968.
Kumar R, Kerbert AJC, Sheikh MF et al. Determinants of mortality in patients with cirrhosis and uncontrolled variceal bleeding. J. Hepatol. 2021; 74: 66-79.