Multicentre randomised controlled study comparing carvedilol with variceal band ligation in the prevention of variceal rebleeding

Adrian J. Stanley, Sheila Dickson, Peter C. Hayes, Ewan H. Forrest, Peter R. Mills, Dhiraj Tripathi, Joanna A. Leithead, Kim MacBeth, Lyn Smith, Daniel R. Gaya, Harry Suzuki, David Young

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

BACKGROUND & AIMS: Rebleeding after an initial oesophageal variceal haemorrhage remains a significant problem despite therapy with band ligation, non-selective β-blockers or a combination of these. Carvedilol is a vasodilating non-selective β-blocker with alpha-1 receptor and calcium channel antagonism. Arecent study has suggested it is effective in the prevention of a first variceal bleed. Our aim was to compare oral carvedilol with variceal band ligation (VBL) in the prevention of rebleeding following a first variceal bleed.

METHODS: Patients who were stable 5 days after presentation with a first oesophageal variceal haemorrhage and had not been taking β-blockers were randomised to oral carvedilol or VBL. Patients were followed-up after one week, monthly, then every 3 months. The primary end point was variceal rebleeding on intention-to-treat analysis.
RESULTS: 64 patients were randomised, 33 to carvedilol and 31 to VBL. 58 (90.6%) patients had alcohol related liver disease. Age and Child-Pugh score were similar in both groups at baseline. Median follow-up was 26.3 (interquartile range [IQR]10.2-46.6) months. Compliance was 68% and 65% for carvedilol and VBL respectively (p=0.993) and serious adverse events between the two groups were similar (p=0.968). Variceal rebleeding occurred during follow-up in 12 (36.4%) and 11 (35.5%) patients in the carvedilol and VBL groups, respectivel y(p=0.857), with 9 (27.3%) and 16 (51.6%) deaths in each group, respectively (p=0.110).
CONCLUSIONS: Carvedilol is not superior to VBL in the prevention of variceal rebleeding. The trend to a survival benefit for patients taking this drug compared with those undergoing banding requires further exploration.
LanguageEnglish
Pages1014-1019
Number of pages6
JournalJournal of Hepatology
Volume61
Issue number5
Early online date19 Jun 2014
DOIs
Publication statusPublished - 1 Nov 2014

Fingerprint

Ligation
Hemorrhage
Intention to Treat Analysis
Calcium Channels
carvedilol
Compliance
Liver Diseases
Alcohols
Survival
Pharmaceutical Preparations

Keywords

  • band ligation
  • carvedilol
  • portal hypertension
  • variceal haemorrhage

Cite this

Stanley, Adrian J. ; Dickson, Sheila ; Hayes, Peter C. ; Forrest, Ewan H. ; Mills, Peter R. ; Tripathi, Dhiraj ; Leithead, Joanna A. ; MacBeth, Kim ; Smith, Lyn ; Gaya, Daniel R. ; Suzuki, Harry ; Young, David. / Multicentre randomised controlled study comparing carvedilol with variceal band ligation in the prevention of variceal rebleeding. In: Journal of Hepatology. 2014 ; Vol. 61, No. 5. pp. 1014-1019.
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title = "Multicentre randomised controlled study comparing carvedilol with variceal band ligation in the prevention of variceal rebleeding",
abstract = "BACKGROUND & AIMS: Rebleeding after an initial oesophageal variceal haemorrhage remains a significant problem despite therapy with band ligation, non-selective β-blockers or a combination of these. Carvedilol is a vasodilating non-selective β-blocker with alpha-1 receptor and calcium channel antagonism. Arecent study has suggested it is effective in the prevention of a first variceal bleed. Our aim was to compare oral carvedilol with variceal band ligation (VBL) in the prevention of rebleeding following a first variceal bleed.METHODS: Patients who were stable 5 days after presentation with a first oesophageal variceal haemorrhage and had not been taking β-blockers were randomised to oral carvedilol or VBL. Patients were followed-up after one week, monthly, then every 3 months. The primary end point was variceal rebleeding on intention-to-treat analysis.RESULTS: 64 patients were randomised, 33 to carvedilol and 31 to VBL. 58 (90.6{\%}) patients had alcohol related liver disease. Age and Child-Pugh score were similar in both groups at baseline. Median follow-up was 26.3 (interquartile range [IQR]10.2-46.6) months. Compliance was 68{\%} and 65{\%} for carvedilol and VBL respectively (p=0.993) and serious adverse events between the two groups were similar (p=0.968). Variceal rebleeding occurred during follow-up in 12 (36.4{\%}) and 11 (35.5{\%}) patients in the carvedilol and VBL groups, respectivel y(p=0.857), with 9 (27.3{\%}) and 16 (51.6{\%}) deaths in each group, respectively (p=0.110).CONCLUSIONS: Carvedilol is not superior to VBL in the prevention of variceal rebleeding. The trend to a survival benefit for patients taking this drug compared with those undergoing banding requires further exploration.",
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author = "Stanley, {Adrian J.} and Sheila Dickson and Hayes, {Peter C.} and Forrest, {Ewan H.} and Mills, {Peter R.} and Dhiraj Tripathi and Leithead, {Joanna A.} and Kim MacBeth and Lyn Smith and Gaya, {Daniel R.} and Harry Suzuki and David Young",
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Stanley, AJ, Dickson, S, Hayes, PC, Forrest, EH, Mills, PR, Tripathi, D, Leithead, JA, MacBeth, K, Smith, L, Gaya, DR, Suzuki, H & Young, D 2014, 'Multicentre randomised controlled study comparing carvedilol with variceal band ligation in the prevention of variceal rebleeding' Journal of Hepatology, vol. 61, no. 5, pp. 1014-1019. https://doi.org/10.1016/j.jhep.2014.06.015

Multicentre randomised controlled study comparing carvedilol with variceal band ligation in the prevention of variceal rebleeding. / Stanley, Adrian J.; Dickson, Sheila; Hayes, Peter C.; Forrest, Ewan H.; Mills, Peter R.; Tripathi, Dhiraj; Leithead, Joanna A.; MacBeth, Kim; Smith, Lyn; Gaya, Daniel R.; Suzuki, Harry; Young, David.

In: Journal of Hepatology, Vol. 61, No. 5, 01.11.2014, p. 1014-1019.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Multicentre randomised controlled study comparing carvedilol with variceal band ligation in the prevention of variceal rebleeding

AU - Stanley, Adrian J.

AU - Dickson, Sheila

AU - Hayes, Peter C.

AU - Forrest, Ewan H.

AU - Mills, Peter R.

AU - Tripathi, Dhiraj

AU - Leithead, Joanna A.

AU - MacBeth, Kim

AU - Smith, Lyn

AU - Gaya, Daniel R.

AU - Suzuki, Harry

AU - Young, David

PY - 2014/11/1

Y1 - 2014/11/1

N2 - BACKGROUND & AIMS: Rebleeding after an initial oesophageal variceal haemorrhage remains a significant problem despite therapy with band ligation, non-selective β-blockers or a combination of these. Carvedilol is a vasodilating non-selective β-blocker with alpha-1 receptor and calcium channel antagonism. Arecent study has suggested it is effective in the prevention of a first variceal bleed. Our aim was to compare oral carvedilol with variceal band ligation (VBL) in the prevention of rebleeding following a first variceal bleed.METHODS: Patients who were stable 5 days after presentation with a first oesophageal variceal haemorrhage and had not been taking β-blockers were randomised to oral carvedilol or VBL. Patients were followed-up after one week, monthly, then every 3 months. The primary end point was variceal rebleeding on intention-to-treat analysis.RESULTS: 64 patients were randomised, 33 to carvedilol and 31 to VBL. 58 (90.6%) patients had alcohol related liver disease. Age and Child-Pugh score were similar in both groups at baseline. Median follow-up was 26.3 (interquartile range [IQR]10.2-46.6) months. Compliance was 68% and 65% for carvedilol and VBL respectively (p=0.993) and serious adverse events between the two groups were similar (p=0.968). Variceal rebleeding occurred during follow-up in 12 (36.4%) and 11 (35.5%) patients in the carvedilol and VBL groups, respectivel y(p=0.857), with 9 (27.3%) and 16 (51.6%) deaths in each group, respectively (p=0.110).CONCLUSIONS: Carvedilol is not superior to VBL in the prevention of variceal rebleeding. The trend to a survival benefit for patients taking this drug compared with those undergoing banding requires further exploration.

AB - BACKGROUND & AIMS: Rebleeding after an initial oesophageal variceal haemorrhage remains a significant problem despite therapy with band ligation, non-selective β-blockers or a combination of these. Carvedilol is a vasodilating non-selective β-blocker with alpha-1 receptor and calcium channel antagonism. Arecent study has suggested it is effective in the prevention of a first variceal bleed. Our aim was to compare oral carvedilol with variceal band ligation (VBL) in the prevention of rebleeding following a first variceal bleed.METHODS: Patients who were stable 5 days after presentation with a first oesophageal variceal haemorrhage and had not been taking β-blockers were randomised to oral carvedilol or VBL. Patients were followed-up after one week, monthly, then every 3 months. The primary end point was variceal rebleeding on intention-to-treat analysis.RESULTS: 64 patients were randomised, 33 to carvedilol and 31 to VBL. 58 (90.6%) patients had alcohol related liver disease. Age and Child-Pugh score were similar in both groups at baseline. Median follow-up was 26.3 (interquartile range [IQR]10.2-46.6) months. Compliance was 68% and 65% for carvedilol and VBL respectively (p=0.993) and serious adverse events between the two groups were similar (p=0.968). Variceal rebleeding occurred during follow-up in 12 (36.4%) and 11 (35.5%) patients in the carvedilol and VBL groups, respectivel y(p=0.857), with 9 (27.3%) and 16 (51.6%) deaths in each group, respectively (p=0.110).CONCLUSIONS: Carvedilol is not superior to VBL in the prevention of variceal rebleeding. The trend to a survival benefit for patients taking this drug compared with those undergoing banding requires further exploration.

KW - band ligation

KW - carvedilol

KW - portal hypertension

KW - variceal haemorrhage

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