Background & Aims:
A previous individual patient data meta-analysis (IPD-MA) showed that compared with drugs+endoscopy, placement of transjugular portosystemic shunt within 72 hrs of admission (preemptive TIPS: p-TIPS) increases the survival of high-risk patients (Child-Pugh B+active bleeding and Child-Pugh C<14points) with cirrhosis and acute variceal bleeding (AVB). However, previous IPD-MA was not a two-stage MA, did not take into consideration the potential risk of selection bias of observational studies, and did not include the most recent RCT. We performed an updated and revised IPD-MA to reassess the efficacy of p-TIPS addressing all previous issues.
Approach & Results:
We included all studies from the previous IPD-MA and searched for other possible eligible publications until September 2022. We performed a two-stage IPD-MA of data from 8 studies (4 RCTs and 4 observational). In addition, we performed a sensitivity analysis excluding those patients dying up to the first 72 hours after admission, in the Drugs+Endoscopy arms of the 4 observational studies. The primary endpoint was the effects of p-TIPS versus Drugs+Endoscopy on 1-year survival.
We identified 1389 patients (342 p-TIPS and 1047 Drugs+Endoscopy). The two-stage IPD-MA, showed that p-TIPS significantly reduced the mortality in overall population, HR=0·43, 95% CI 0·32-0·60, p<0·001. This effect was observed in both subgroups of Child-Pugh patients. The sensitivity analysis, confirmed the survival benefit of p-TIPS.
Conclusions:
The updated two-stage IPD-MA confirms the significant survival advantage of p-TIPS in high-risk patients with cirrhosis and AVB. As a result, we recommend p-TIPS as the preferred first-choice treatment for these patients.