Background & Aims

Further decompensation represents a prognostic stage of cirrhosis associated with higher mortality compared with first decompensation. A transjugular intrahepatic portosystemic shunt (TIPS) is indicated to prevent variceal rebleeding and for refractory ascites, but its overall efficacy to prevent further decompensations is unknown. This study assessed the incidence of further decompensation and mortality after TIPS vs. standard of care (SOC).

Methods

Controlled studies assessing covered TIPS compared with SOC for the indication of refractory ascites and prevention of variceal rebleeding published from 2004 to 2020 were considered. We collected individual patient data (IPD) to perform an IPD meta-analysis and to compare the treatment effect in a propensity score (PS)-matched population. Primary outcome was the incidence of further decompensation and the secondary outcome was overall survival.

Results

In total, 3,949 individual patient data sets were extracted from 12 controlled studies and, after PS matching, 2,338 patients with similar characteristics (SOC = 1,749; TIPS = 589) were analysed. The 2-year cumulative incidence function of further decompensation in the PS-matched population was 0.48 (95% CI 0.43–0.52) in the TIPS group vs. 0.63 (95% CI 0.61–0.65) in the SOC group (stratified Gray’s test, p <0.0001), considering mortality and liver transplantation as competing events. The lower further decompensation rate with TIPS was confirmed by adjusted IPD meta-analysis (hazard ratio 0.44; 95% CI 0.37–0.54) and was consistent across TIPS indication subgroups. The 2-year cumulative survival probability was higher with TIPS than with SOC (0.71 vs. 0.63; p = 0.0001).

Conclusions

The use of TIPS for refractory ascites and for prevention of variceal rebleeding reduces the incidence of a further decompensation event compared with SOC and increases survival in highly selected patients.

Impact and implications

A further decompensation (new or worsening ascites, variceal bleeding or rebleeding, hepatic encephalopathy, jaundice, hepatorenal syndrome–acute kidney injury and spontaneous bacterial peritonitis) in patients with cirrhosis is associated with a poor prognosis. Besides the known role of TIPS in portal hypertension-related complications, this study shows that TIPS is also able to decrease the overall risk of a further decompensation and increase survival compared with standard of care. These results further support the role of TIPS in the management of patients with cirrhosis and portal hypertension-related complications.

中文翻译：

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在个体患者数据荟萃分析中，TIPS 可防止肝硬化和门脉高压患者进一步失代偿并提高生存率

背景与目标

与第一次失代偿相比，进一步失代偿代表了与更高死亡率相关的肝硬化预后阶段。经颈静脉肝内门体分流术（TIPS）可预防静脉曲张再出血和顽固性腹水，但其预防进一步失代偿的总体功效尚不清楚。这项研究评估了 TIPS与 TIPS后进一步失代偿和死亡率的发生率。护理标准（SOC）。

方法

考虑了 2004 年至 2020 年发表的对照研究，评估了 TIPS 与 SOC 在顽固性腹水适应症和预防静脉曲张再出血方面的比较。我们收集了个体患者数据 (IPD) 以进行 IPD 荟萃分析，并比较倾向评分 (PS) 匹配人群中的治疗效果。主要结局是进一步失代偿的发生率，次要结局是总生存率。

结果

总共从 12 项对照研究中提取了 3,949 名个体患者数据集，并在 PS 匹配后，分析了 2,338 名具有相似特征的患者 (SOC = 1,749；TIPS = 589)。PS 匹配人群中进一步失代偿的 2 年累积发生率函数在 TIPS 组中为 0.48（95% CI 0.43-0.52），而 SOC 组为 0.63 (95% CI 0.61–0.65)（分层格雷检验，p <0.0001），将死亡率和肝移植视为竞争事件。调整后的 IPD 荟萃分析证实了 TIPS 较低的进一步失代偿率（风险比 0.44；95% CI 0.37-0.54），并且在 TIPS 适应症亚组中是一致的。TIPS 的 2 年累积生存概率高于 SOC（0.71 vs 0.63；p  = 0.0001）。

结论

与 SOC 相比，使用 TIPS 治疗难治性腹水和预防静脉曲张再出血可降低进一步失代偿事件的发生率，并提高精心挑选的患者的生存率。

影响和影响

肝硬化患者的进一步失代偿（新发或恶化的腹水、静脉曲张出血或再出血、肝性脑病、黄疸、肝肾综合征 - 急性肾损伤和自发性细菌性腹膜炎）与不良预后相关。除了 TIPS 在门静脉高压相关并发症中的已知作用外，这项研究表明，与标准护理相比，TIPS 还能够降低进一步失代偿的总体风险并提高生存率。这些结果进一步支持了 TIPS 在治疗肝硬化和门脉高压相关并发症患者中的作用。