Multicenter prospective randomized controlled trial comparing propranolol, endoscopic band ligation, and combination therapy for the primary prophylaxis variceal bleeding in patients with liver cirrhosis

Seo, Yousuke; Kim, M.Y.; Yim, Hyung Joon; Kim, H.S.; Kim, S.G.; Park, S.Y.; Kim, B.I.; Park, J.Y.; An, Heeyoung; Baik, S.K.; Kim, Y.S.; Tak, Won Young; Han, Kwang‐Hyub; Um, Soon-Ho

doi:10.1016/s0168-8278(17)30330-6

Cited by 9 publications

(20 citation statements)

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“…There was also no difference between EBL monotherapy or EBL + NSBB combination therapy in secondary prophylaxis. However, we found superior survival in the NSBB monotherapy as compared to the EBL + NSBB group—which is most likely attributable to a selection bias with exclusively confirmed haemodynamic responders in the NSBB trials by Reiberger et al However, a recent trial showed that EBL + NSBB combination therapy was more effective in reducing the incidence of first variceal bleeding especially in high risk oesophageal varices than monotherapy with EBL with less recurrence of varices in the EBL + NSBB group than with EBL alone . Ultimately, this strategy remains to be confirmed in future studies.…”

Section: Discussionmentioning

confidence: 99%

Betablockers do not increase efficacy of band ligation in primary prophylaxis but they improve survival in secondary prophylaxis of variceal bleeding

Pfisterer

Dexheimer

Fuchs

et al. 2018

Aliment Pharmacol Ther

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Summary Background Endoscopic band ligation (EBL) is used for primary (PP) and secondary prophylaxis (SP) of variceal bleeding. Current guidelines recommend combined use of non‐selective beta‐blockers (NSBBs) and EBL for SP, while in PP either NSBB or EBL should be used. Aim To assess (re‐)bleeding rates and mortality in cirrhotic patients receiving EBL for PP or SP for variceal bleeding. Methods (Re‐)bleeding rates and mortality were retrospectively assessed with and without concomitant NSBB therapy after first EBL in PP and SP. Results Seven hundred and sixty‐six patients with oesophageal varices underwent EBL from 01/2005 to 06/2015. Among the 284 patients undergoing EBL for PP, n = 101 (35.6%) received EBL only, while n = 180 (63.4%) received EBL + NSBBs. In 482 patients on SP, n = 163 (33.8%) received EBL only, while n = 299 (62%) received EBL + NSBBs. In PP, concomitant NSBB therapy neither decreased bleeding rates (log‐rank: P = 0.353) nor mortality (log‐rank: P = 0.497) as compared to EBL alone. In SP, similar re‐bleeding rates were documented in EBL + NSBB vs EBL alone (log‐rank: P = 0.247). However, EBL + NSBB resulted in a significantly lower mortality rate (log‐rank: P<0.001). A decreased risk of death with EBL + NSBB in SP (hazard ratio, HR: 0.50; P<0.001) but not of rebleeding, transplantation or further decompensation was confirmed by competing risk analysis. Overall NSBB intake reduced 6‐months mortality (HR: 0.53, P = 0.008) in SP, which was most pronounced in patients without severe/refractory ascites (HR: 0.37; P = 0.001) but not observed in patients with severe/refractory ascites (HR: 0.80; P = 0.567). Conclusions EBL alone seems sufficient for PP of variceal bleeding. In SP, the addition of NSBB to EBL was associated with an improved survival within the first 6 months after EBL.

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Section: Discussionmentioning

confidence: 99%

Betablockers do not increase efficacy of band ligation in primary prophylaxis but they improve survival in secondary prophylaxis of variceal bleeding

Pfisterer

Dexheimer

Fuchs

et al. 2018

Aliment Pharmacol Ther

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“…The incidence of variceal bleeding was significantly lower in the combined treatment group (3.4%) compared to the propranolol alone group (14%, P =0.012) and EBL alone group (14.9%, P =0.008) without difference in mortality rate within 2 years. In addition, numbers of EBL sessions and used rubber bands for EV eradication and EV recurrence rate after eradication by EBL were significantly lower in the combined treatment group in this study [ 128 ]. Because this well-designed large-scale RCT showed superiority of combined treatment for the primary prophylaxis, revision of recommendation of practice guidelines should be considered.…”

Section: Management Of Esophageal Varicesmentioning

confidence: 92%

“…Thus, because most of studies showed no significant benefit of combined treatment compared with single treatment, current guidelines do not recommend combined treatment for primary prophylaxis. However, very recently, a large scale multicenter RCT was presented at the International Liver Congress of the European Association for the Study of the Liver on April, 2017 [ 128 ]. In this study, 290 cirrhotic patients with medium or large varices with red color sign without previous history of bleeding were randomized propranolol alone, EBL alone, and combined treatment.…”

Section: Management Of Esophageal Varicesmentioning

confidence: 99%

Prevention and management of gastroesophageal varices

Seo

2018

Clin Mol Hepatol

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Bleeding from gastroesophageal varices is a serious complication in patients with liver cirrhosis and portal hypertension. Although there has been significance improvement in the prognosis of variceal bleeding with advancement in diagnostic and therapeutic modalities for its management, mortality rate still remains high. Therefore, appropriate prevention and rapid, effective management of bleeding from gastroesophageal varices is very important. Recently, various studies about management of gastoesophageal varices, including prevention of development and aggravation of varices, prevention of first variceal bleeding, management of acute variceal bleeding, and prevention of variceal rebleeding, have been published. The present article reviews published articles and practice guidelines to present the most optimal management of patients with gastroesophageal varices.

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“…Adverse event rates were not described. 36 It is still unclear whether combination therapy is more effective and safer for primary prophylaxis.…”

Section: Indicationsmentioning

confidence: 99%

Beta-blockers in cirrhosis: Evidence-based indications and limitations

2020

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Non-selective beta-blockers (NSBBs) are the mainstay of treatment for portal hypertension in the setting of liver cirrhosis. Randomised controlled trials demonstrated their efficacy in preventing initial variceal bleeding and subsequent rebleeding. Recent evidence indicates that NSBBs could prevent liver decompensation in patients with compensated cirrhosis. Despite solid data favouring NSBB use in cirrhosis, some studies have highlighted relevant safety issues in patients with endstage liver disease, particularly with refractory ascites and infection. This review summarises the evidence supporting current recommendations and restrictions of NSBB use in patients with cirrhosis.

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Multicenter prospective randomized controlled trial comparing propranolol, endoscopic band ligation, and combination therapy for the primary prophylaxis variceal bleeding in patients with liver cirrhosis

Cited by 9 publications

References 0 publications

Betablockers do not increase efficacy of band ligation in primary prophylaxis but they improve survival in secondary prophylaxis of variceal bleeding

Betablockers do not increase efficacy of band ligation in primary prophylaxis but they improve survival in secondary prophylaxis of variceal bleeding

Prevention and management of gastroesophageal varices

Beta-blockers in cirrhosis: Evidence-based indications and limitations

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