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

J Hepatol. 2014 Nov;61(5):1014-9. doi: 10.1016/j.jhep.2014.06.015. Epub 2014 Jun 19.


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. 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 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, 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.

Keywords: Band ligation; Carvedilol; Portal hypertension; Variceal haemorrhage.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adrenergic beta-Antagonists / adverse effects
  • Adrenergic beta-Antagonists / therapeutic use*
  • Adult
  • Blood Pressure / drug effects
  • Carbazoles / adverse effects
  • Carbazoles / therapeutic use*
  • Carvedilol
  • Esophageal and Gastric Varices / drug therapy*
  • Esophageal and Gastric Varices / prevention & control
  • Esophageal and Gastric Varices / surgery*
  • Female
  • Gastrointestinal Hemorrhage / drug therapy*
  • Gastrointestinal Hemorrhage / prevention & control
  • Gastrointestinal Hemorrhage / surgery*
  • Heart Rate / drug effects
  • Humans
  • Ligation
  • Male
  • Medication Adherence
  • Middle Aged
  • Propanolamines / adverse effects
  • Propanolamines / therapeutic use*
  • Recurrence


  • Adrenergic beta-Antagonists
  • Carbazoles
  • Propanolamines
  • Carvedilol