Department of Hepatology, Royal Infirmary of Edinburgh, Edinburgh, UK.
Liver Unit, Queen Elizabeth Hospital, Birmingham, UK.
Aliment Pharmacol Ther. 2021 Feb;53(4):531-539. doi: 10.1111/apt.16189. Epub 2020 Dec 9.
Primary prophylaxis of variceal haemorrhage with non-selective beta blockers (NSBB) or variceal band ligation (VBL) is now standard of care in patients with cirrhosis with portal hypertension. NSBB, and particularly carvedilol, may be associated with improved survival.
To assess mortality in a cohort of patients previously randomised to either carvedilol or VBL.
We retrospectively analysed 152 patients recruited to a multi-centre randomised controlled trial between 7 April 2000 and 24 June 2006 designed to assess the efficacy of VBL versus carvedilol in preventing first variceal bleed. We used electronic records to undertake long-term follow-up (up to 20 years) with the primary outcome of all-cause mortality and secondary end points of liver-related mortality and decompensation events (ascites, encephalopathy, variceal bleeding).
We included 152 patients in analysis with baseline characteristics well matched between the carvedilol (n = 77) and VBL (n = 75) groups. In the intention-to-treat analysis, carvedilol offered a significant survival advantage with median survival of 7.8 years compared to 4.2 years in the VBL group (P = 0.03). This survival benefit was maintained in per-protocol analysis when patients who crossed between treatment arms were excluded (P = 0.02). Transplant-free survival, liver-related mortality and decompensation events were similar in both groups.
These data suggest that carvedilol offers a significant survival benefit for patients with cirrhosis and portal hypertension. The difference in all-cause and liver-related mortality suggests that this survival benefit may not be entirely liver-related. Prospective, studies are required to confirm these important findings.
非选择性β受体阻滞剂(NSBB)或套扎治疗(VBL)预防静脉曲张出血已成为肝硬化伴门静脉高压患者的标准治疗方法。NSBB,特别是卡维地洛,可能与改善生存率相关。
评估曾随机分配至卡维地洛或 VBL 治疗的患者队列的死亡率。
我们回顾性分析了 2000 年 4 月 7 日至 2006 年 6 月 24 日期间入组的多中心随机对照试验的 152 例患者,该试验旨在评估 VBL 与卡维地洛预防首次静脉曲张出血的疗效。我们使用电子病历进行长期随访(最长 20 年),主要终点为全因死亡率,次要终点为与肝脏相关的死亡率和失代偿事件(腹水、脑病、静脉曲张出血)。
我们纳入了 152 例患者进行分析,卡维地洛组(n=77)和 VBL 组(n=75)的基线特征匹配良好。意向治疗分析显示,卡维地洛治疗组的中位生存时间为 7.8 年,VBL 治疗组为 4.2 年(P=0.03),卡维地洛治疗组具有显著的生存优势。当排除治疗组之间交叉的患者后,在方案分析中也观察到了这种生存获益(P=0.02)。两组之间无移植生存率、与肝脏相关的死亡率和失代偿事件相似。
这些数据表明,卡维地洛为肝硬化伴门静脉高压患者提供了显著的生存获益。全因和肝脏相关死亡率的差异表明,这种生存获益可能不完全与肝脏相关。需要前瞻性研究来证实这些重要发现。