Introduction Rebleeding after an initial oesophageal variceal haemorrhage remains a significant problem despite therapy with band ligation ± non-selective ß-blockers. Carvedilol is a vasodilating non-selective ß-blocker with alpha-1 receptor and calcium channel antagonism. It has a greater portal hypotensive effect than propranolol and has been shown to be effective in the prevention of a first variceal bleed. Our aim was to compare oral carvedilol with band ligation in the prevention of rebleeding following a first variceal bleed.
Methods Patients who were stable 5 days after presentation with a first variceal haemorrhage and had not been taking (or had contraindications to) ß-blockers, were randomised to oral carvedilol (6.25 mg daily then 12.5 mg daily after one week if tolerated) or a band ligation programme. Patients were followed up at clinic after one week, monthly, then 3-monthly. The primary end-point was variceal rebleeding, on intention-to-treat analysis.
Results 63 patients were randomised, 32 to carvedilol and 31 to banding. Fifty-six (89%) patients had alcohol related liver disease. There was no difference in baseline mean age (51 yrs ± 10.9 and 50 yrs ± 13.0) or median Childs Pugh score (9, IQR 6–11 and 9, IQR 8–11) for patients randomised to carvedilol or banding respectively. Mean follow-up was 29 months. Compliance was 72% and 90% for carvedilol and banding respectively (p = 0.14) and there was no difference in the number of serious adverse events between the two groups. Variceal rebleeding occurred during follow-up in 12 (37.5%) and 9 (29.0%) patients in the carvedilol and banding groups respectively (p = 0.72), with mortality 25.0% and 51.6% respectively (p = 0.058). The differences in outcome the between groups were similar using per protocol analysis. This interim analysis indicates that to show a significant difference in rebleeding, 482 patients would be required in each group.
Conclusion Carvedilol is not clearly superior to band ligation in the prevention of variceal rebleeding. However there appears to be a survival benefit for patients taking this drug compared with those undergoing banding, which requires further exploration.
Disclosure of Interest None Declared
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