Carvedilol Associated with Ligation For The Prophylaxis of First Esophageal Variceal Bleeding: A Novel Approach of Long-Term Study
Author(s): Gin-Ho Lo, Jen-Hao Yeh, Hsueh-Chou Lai, Chi-I Chen, Chi-Ming Tai, Chih-Wen Lin, Hui- Chen Lin
The role of combining banding ligation with β-blockers in the prophylaxis of first esophageal variceal bleeding is unsettled. We conducted a trial to assess the value of carvedilol plus banding ligation in the prophylaxis of 1st bleeding.
Subjects and methods
Cirrhotic patients with high risk esophageal varices who have never bled were randomized to 2 groups. The Carvedilol group received regular carvedilol administration alone while Combination group received 3 sessions of banding ligation at 3 and 12 months interval additional to carvedilol administration. End points were first variceal bleeding and survival.
A total of 65 patients were enrolled, 34 patients in the Carvedilol group, and 31 patients in Combination group. Both groups were comparable in baseline data. The mean dose of carvedilol was similar in both groups. A mean of 2.7 session of banding ligation was performed in the Combination group. After a follow-up up to 9 years, 16 patients in the Carvedilol group encountered esophageal variceal bleeding while 3 patients in the Combination group bled (p<0.001, hazard ratio 5.52; confidence interval 2.19-13.9). Upper gastrointestinal bleeding was experienced in 21 patients and 6 patients in the Carvedilol group and Combination group, respectively. Adverse events were similar between both groups. There were 23 deaths (67%) in the Carvedilol group and 11 deaths (35%) in the Combination group (p= 0.03, hazard ratio 2.08; confidence interval 1.06-4.92).
Carvedilol combined with banding ligation proved more effective than carvedilol alone in the prevention of first esophageal v