Randomized Controlled Trial of Carvedilol vs Variceal Band Ligation in the Primary Prophylaxis of Variceal Haemorrhage

Abstract

Purpose: To compare the efficacy of carvedilol with endoscopic variceal ligation (EVL) for primary prophylaxis of first variceal bleed. Methods: Randomized, controlled, multicenter trial was conducted in three tertiary care hospitals of Karachi over a period of 5 years. Cirrhotic patients with grade II or larger esophageal varices were allocated to Carvedilol 12.5 mg once daily or EVL performed every 2 weeks until eradication. First visit was 6 weeks after initiation of treatment and 3 monthly thereafter. End points were esophageal variceal bleeding, death and transplant. Analyses were made on intention to treat basis. Results: 200 patients were evaluated, out of which 81 patients were enrolled in carvedilol arm and 78 in EVL arm. Mean age of study participants was 47±12.4 years. 120 (75.47%) were males. 89.3% had viral hepatitis; mean Child-Pugh score was 8.63±1.8 and median follow-up was 11.5±7.8 months (range 1-24 months). Both the treatment groups were comparable regarding baseline characteristics. Outcome measures analyses revealed EVL had a trend towards lower variceal bleeding rates (2.5% vs. 3.7%) as well as overall mortality rates (14.1%vs 18.5%) which were, however, statistically not significant. Bleeding related mortality comparing EVL and carvedilol was also similar; 4.9% vs. 5.1%, respectively. No serious adverse events were recorded in either group. Conclusion: Carvedilol was found to be equally effective and safe compared to esophageal variceal ligation in preventing first bleed as well as mortality in patients with esophageal varices, who have not previously bled.