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 journalArticlepeer-review

Abstract

BACKGROUND AND AIM: Rebleeding after an initial oesophageal variceal haemorrhage remains a significant problem despite therapy with band ligation, non-selective ß-blockers or a combination of these. Carvedilol is a vasodilating non-selective ß-blocker with alpha-1 receptor and calcium channel antagonism. A recent 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 ß-blockers were randomised to oral carvedilol or VBL. Patients were followed up after one week, monthly then 3-monthly. The primary end-point was variceal rebleeding, on intention-to-treat analysis.

RESULTS: 64 patients were randomised, 33 to carvedilol and 31 to VBL. Fifty-eight (90.6%) patients had alcohol related liver disease. Age and Childs-Pugh score were similar in both groups at baseline. Median follow-up was 26.3 (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 was 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 respectively (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 languageEnglish
JournalJournal of Hepatology
DOIs
Publication statusPublished - 19 Jun 2014

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