Abstract
CARVEDILOL PLUS NUCS TO PREVENT THE PROGRESSION OF ESOPHAGEAL VARICES IN VIROLOGICAL SUPPRESSED HBV-CIRRHOSIS PATIENTS: A RANDOMISED, OPEN-LABEL TRIAL.
Background:
Portal hypertension progression can be relieved after controlling the etiology of liver cirrhosis. Whether beta-blockers could additionally enhance the effects during treatment, particularly for mild esophageal varices (EVs), was unclear. This study aims to assess the efficacy of add-on carvedilol to delay EVs progression during anti-HBV treatment in HBV-related cirrhosis.
Methods: This randomised controlled trial enrolled patients with HBV-related cirrhosis and mild/moderate EVs. The participants were randomly assigned to receive NUCs or carvedilol 12.5 mg plus NUCs (1:1 allocation ratio). The primary endpoint was the progression rate of EVs at 2 years of follow-up (NCT 03736265).
Results:
Totals of 238 patients (mild EVs, 77.3%) were randomised into 119 NUCs and 119 carvedilol plus NUCs (CARV combination group). Among them, 205 patients (86.1%) completed paired endoscopies. EVs progression rate was 15.5% (16/103) in NUCs group and 12.7% (13/102) in CARV combination group (RR = 0.80, 95%CI 0.36-1.77, p = 0.59). Subgroup analysis on moderate EVs showed CARV combination group had a more favorable effect in promoting EVs regression (43.5% vs. 13.1%, p = 0.03) than NUCs alone, but not in mild cases (p = 0.50). The incidence of liver-related events (decompensation, hepatocellular carcinoma, or death/liver transplantation) within 2 years was similar between the two groups (11.2% vs. 10.4%, p = 0.88).
Conclusion:
In virological suppressed HBV-cirrhosis patients, the added carvedilol strategy was non-inferior to NUCs monotherapy to prevent progression in esophageal varices. However, the carvedilol-added approach might improve the outcome for patients with moderate varices.