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

Stanley, Adrian J. and Dickson, Sheila and Hayes, Peter C. and Forrest, Ewan H. and Mills, Peter R. and Tripathi, Dhiraj and Leithead, Joanna A. and MacBeth, Kim and Smith, Lyn and Gaya, Daniel R. and Suzuki, Harry and Young, David (2014) Multicentre randomised controlled study comparing carvedilol with variceal band ligation in the prevention of variceal rebleeding. Journal of Hepatology, 61 (5). pp. 1014-1019. ISSN 0168-8278

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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.