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.
| Original language | English |
|---|---|
| Pages (from-to) | 1014-1019 |
| Number of pages | 6 |
| Journal | Journal of Hepatology |
| Volume | 61 |
| Issue number | 5 |
| Early online date | 19 Jun 2014 |
| DOIs | |
| Publication status | Published - 1 Nov 2014 |
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Keywords
- band ligation
- carvedilol
- portal hypertension
- variceal haemorrhage
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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 journal › Article
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
UR - http://www.scopus.com/inward/record.url?scp=84932158739&partnerID=8YFLogxK
UR - http://www.sciencedirect.com/science/article/pii/S0168827814004127
UR - http://www.sciencedirect.com/science/journal/01688278
U2 - 10.1016/j.jhep.2014.06.015
DO - 10.1016/j.jhep.2014.06.015
M3 - Article
VL - 61
SP - 1014
EP - 1019
JO - Journal of Hepatology
JF - Journal of Hepatology
SN - 0168-8278
IS - 5
ER -