Liver Failure, Cirrhosis and Portal Hyptertension
Article first published online: 24 APR 2009
Copyright © 2009 American Association for the Study of Liver Diseases
Volume 50, Issue 3, pages 825–833, September 2009
How to Cite
Tripathi, D., Ferguson, J. W., Kochar, N., Leithead, J. A., Therapondos, G., Mcavoy, N. C., Stanley, A. J., Forrest, E. H., Hislop, W. S., Mills, P. R. and Hayes, P. C. (2009), Randomized controlled trial of carvedilol versus variceal band ligation for the prevention of the first variceal bleed. Hepatology, 50: 825–833. doi: 10.1002/hep.23045
Potential conflicts of interest: Nothing to report.
The trial described in this work has been registered under the following trial number: ISRCTN26269039. The trial can be accessed at http://www.controlled-trials.com/ISRCTN26269039.
- Issue published online: 27 AUG 2009
- Article first published online: 24 APR 2009
- Accepted manuscript online: 24 APR 2009 12:00AM EST
- Manuscript Accepted: 16 APR 2009
- Manuscript Received: 4 AUG 2008
- University of Edinburgh
Current therapy for preventing the first variceal bleed includes beta-blocker and variceal band ligation (VBL). VBL has lower bleeding rates, with no differences in survival, whereas beta-blocker therapy can be limited by side effects. Carvedilol, a non-cardioselective vasodilating beta-blocker, is more effective in reducing portal pressure than propranolol; however, there have been no clinical studies assessing the efficacy of carvedilol in primary prophylaxis. The goal of this study was to compare carvedilol and VBL for the prevention of the first variceal bleed in a randomized controlled multicenter trial. One hundred fifty-two cirrhotic patients from five different centers with grade II or larger esophageal varices were randomized to either carvedilol 12.5 mg once daily or VBL performed every 2 weeks until eradication using a multibander device. Seventy-seven patients were randomized to carvedilol and 75 to VBL. Baseline characteristics did not differ between the groups (alcoholic liver disease, 73%; median Child-Pugh score, 8; median age, 54 years; median follow-up, 20 months). On intention-to-treat analysis, carvedilol had lower rates of the first variceal bleed (10% versus 23%; relative hazard 0.41; 95% confidence interval 0.19-0.96 [P = 0.04]), with no significant differences in overall mortality (35% versus 37%, P = 0.71), and bleeding-related mortality (3% versus 1%, P = 0.26). Six patients in the VBL group bled as a result of banding ulcers. Per-protocol analysis revealed no significant differences in the outcomes. Conclusion: Carvedilol is effective in preventing the first variceal bleed. Carvedilol is an option for primary prophylaxis in patients with high-risk esophageal varices. (HEPATOLOGY 2009.)