This individual patient data meta-analysis evaluates endovascular interventions versus endoscopic cyanoacrylate injection for patients with cirrhosis and gastric variceal hemorrhage. The analysis included 1240 patients and assessed all-cause rebleeding as the primary outcome along with overall survival, ascites, and hepatic encephalopathy as secondary outcomes. Follow-up duration was not reported.
Endovascular interventions including balloon-occluded retrograde transvenous obliteration and transjugular intrahepatic portosystemic shunt significantly reduced rebleeding compared to endoscopic cyanoacrylate injection. The subdistribution hazard ratio for rebleeding with balloon-occluded retrograde transvenous obliteration versus endoscopic cyanoacrylate injection was 0.15 with a 95% CI of 0.05-0.43 and a P value of .004. For transjugular intrahepatic portosystemic shunt versus endoscopic cyanoacrylate injection, the subdistribution hazard ratio was 0.49 with a 95% CI of 0.27-0.89 and a P value of .019.
However, endovascular interventions carry specific safety risks. Balloon-occluded retrograde transvenous obliteration increased the risk of new-onset or worsening of pre-existing ascites with a subdistribution hazard ratio of 3.54 and a 95% CI of 1.31-9.55 (P = .013). Transjugular intrahepatic portosystemic shunt increased the risk of hepatic encephalopathy with a subdistribution hazard ratio of 8.84 and a 95% CI of 2.0-39.11 (P = .004). Survival benefit was not reported.
The authors highlight limitations including limited long-term outcome data, inconsistencies in reported trial outcomes, and significant heterogeneity in results particularly regarding transjugular intrahepatic portosystemic shunt. Funding or conflicts were not reported.
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BACKGROUND & AIMS: There is no consensus on the optimal modality of secondary prophylaxis for gastric variceal (GV) bleeding in patients with cirrhosis.
METHODS: Observational studies and randomized controlled trials (RCTs) comparing endovascular interventions-balloon-occluded retrograde transvenous obliteration (BRTO) and transjugular intrahepatic portosystemic shunt (TIPS)-with endoscopic cyanoacrylate injection (ECI) were considered for the aggregate data meta-analysis. Individual patient data were collected from RCTs to perform an individual patient data meta-analysis in a propensity score-matched cohort. The primary outcome was comparison of the rates of all-cause rebleeding between ECI, BRTO, and TIPS. Secondary outcomes included overall survival, ascites, and hepatic encephalopathy.
RESULTS: Fifteen studies (11 observational and 4 RCTs) comprising 1240 patients (ECI: 377, BRTO: 575, and TIPS: 288) were included in the aggregate data meta-analysis. In the individual patient data meta-analysis, both BRTO (subdistribution hazard ratio [sHR], 0.15; 95% confidence interval [CI], 0.05-0.43; P = .004) and TIPS (sHR, 0.49; 95% CI, 0.27-0.89; P = .019) significantly reduced all-cause rebleeding compared with ECI, without survival benefit. BRTO was associated with a higher risk of new-onset or worsening of pre-existing ascites (sHR, 3.54; 95% CI, 1.31-9.55; P = .013); TIPS increased the risk of hepatic encephalopathy (sHR, 8.84; 95% CI, 2.0-39.11; P = .004) compared with ECI. Benefit in rebleeding reduction was most pronounced among patients with Child-Pugh class B cirrhosis. The analysis revealed limited long-term outcome data, inconsistencies in reported trial outcomes, and significant heterogeneity in results, particularly regarding TIPS.
CONCLUSIONS: Endovascular interventions (BRTO and TIPS) are superior to ECI for reducing all-cause rebleeding in patients with cirrhosis and gastric variceal hemorrhage. Larger studies with standardized end points and long-term outcomes are needed to clarify survival benefit and optimize treatment selection.