OBJECTIVES 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 small 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 virologically suppressed HBV compensated cirrhosis patients with small/medium 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. RESULTS Totals of 238 patients (small 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 = 0.79, 95% CI 0.36-1.75, P = 0.567). Subgroup analysis on medium EVs showed CARV combination group had a more favorable effect in promoting EVs regression (43.5% vs. 13.1%, P = 0.022) than NUCs alone, but not in small cases (P = 0.534). 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 = 0.881). CONCLUSIONS The overall results did not show statistically significant differences between the added carvedilol strategy and NUCs monotherapy in preventing EVs progression in virologically suppressed HBV-cirrhosis patients. However, the carvedilol-added approach might offer improved outcomes specifically for patients with medium EVs (NCT03736265).

中文翻译：

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卡维地洛加 NUC 用于治疗病毒学抑制下的代偿性 HBV 肝硬化患者：一项随机、开放标签试验。

目的 控制肝硬化的病因后，可以缓解门脉高压的进展。β受体阻滞剂是否可以额外增强治疗期间的效果，特别是对于小食管静脉曲张（EV），目前尚不清楚。本研究旨在评估在 HBV 相关肝硬化抗 HBV 治疗期间添加卡维地洛延迟 EV 进展的功效。方法 这项随机对照试验纳入了病毒学抑制的 HBV 代偿性肝硬化患者，其 EV 较小/中等。参与者被随机分配接受 NUC 或卡维地洛 12.5 mg 加 NUC（1:1 分配比例）。主要终点是随访 2 年时 EV 的进展率。结果 共有 238 名患者（小 EV，77.3%）被随机分为 119 名 NUC 和 119 名卡维地洛加 NUC（CARV 联合组）。其中，205名患者（86.1%）完成了配对内窥镜检查。NUCs 组的 EV 进展率为 15.5% (16/103)，CARV 联合组为 12.7% (13/102)（RR = 0.79，95% CI 0.36-1.75，P = 0.567）。对中型 EV 的亚组分析显示，CARV 联合组比单独使用 NUC 对促进 EV 消退有更有利的效果（43.5% vs. 13.1%，P = 0.022），但在小病例中则不然（P = 0.534）。两组之间 2 年内肝脏相关事件（失代偿、肝细胞癌或死亡/肝移植）的发生率相似（11.2% vs. 10.4%，P = 0.881）。结论 总体结果显示，在病毒学抑制的 HBV 肝硬化患者中，添加卡维地洛策略和 NUC 单一疗法在预防 EV 进展方面没有统计学上的显着差异。然而，添加卡维地洛的方法可能会特别针对中等 EV 患者提供改善的结果 (NCT03736265)。