Table 2.
Randomised controlled trials on the use of TIPS for secondary prophylaxis of AVB.
| Author | Sample size; Intervention and comparator |
Main inclusion criteria | Main exclusion criteria | Safety | Efficacy |
|---|---|---|---|---|---|
| Escorsell et al.57 | 91 patients randomised 1:1; Uncovered 10 mm dilated to 8-10 mm vs. propranolol plus ISMN plus EVL |
Within 2 weeks of AVB controlled with vasoactive drugs plus endoscopy (preferably EVL); Child-Pugh B/C | Age <18/>75 years; HCC; Occlusive PVT; Previous TIPS; Chronic renal failure; Alcoholic hepatitis; Bilirubin >10 mg/dl; Prothrombin index <30%; PLT <20 G/L | 70% required TIPS revision; Increase in de novo PSE during follow-up in the TIPS group; Trend towards increase in hospital admissions due to PSE in the TIPS group |
Rebleeding at 2 years: 13% vs. 49%, favouring TIPS; Mortality at 2 years: 28% vs. 28% (n.s.); De novo or worsening of ascites: 7% vs. 21%, favouring TIPS; Similar quality of life |
| Sauer et al.58 | 85 patients randomised 1:1; Uncovered dilated to 8-12 mm vs. propranolol |
Within 3 days of control of AVB with vasoactive drugs plus endoscopy (sclerotherapy) | Gastric varices; Previous endoscopic or surgical therapies; PVT; Grade 3/4 HE; Severe extrahepatic comorbidities | 89% required TIPS revision; Increase in PSE during follow-up in the TIPS group |
Failure to control bleeding or all-cause rebleeding at 5 years: 31.1% vs. 38.9% (n.s.); Failure to control bleeding or rebleeding from varices at 5 years: 19.4% vs. 29.9% (n.s.); Mortality at 5 years: 24.1% vs. 17.8% (n.s.) |
| Sauerbruch et al.59 | 185 patients randomised 1:1; PFTE-covered 8 mm dilated to 8 mm vs. HVPG-guided therapy: propranolol plus ISMN or EVL monotherapy | Within 21 (56%) or after >21 days (44%) of AVB controlled with vasoactive drugs plus endoscopy (EVL) | Age <18/>75 years; Child-Pugh ≥12 points; MELD >30 points; Previous NSBB treatment; Previous TIPS; Bilirubin >3 mg/dl; Prothrombin index <30%; PLT <30 G/L | Increase in PSE during follow-up in the TIPS group | Rebleeding at 2 years: 7% vs. 26%, favouring TIPS - driven by stratum I; Mortality at 2 years: similar; Similar quality of life |
| Holster et al.62 | 72 patients randomised 1:1; PFTE-covered 10 mm dilated to 8-10 mm vs. propranolol plus EVL or cyanoacrylate |
At a median of 4 days after a first or second AVB controlled with vasoactive drugs plus endoscopy (EVL or cyanoacrylate) | Age <18/>75 years; Grade 3/4 HE; Heart failure NYHA III/IV; PVT; Previous TIPS; Advanced HCC; Child-Pugh >13 points; Sepsis and/or ACLF | Increase in PSE at 1 year in TIPS group, but during long-term follow-up, this difference diminished | Rebleeding: 0% vs. 29%, favouring TIPS; Mortality: 32% vs. 26% (n.s.) |
AVB, acute variceal bleeding; ACLF, acute-on-chronic liver failure; EVL, endoscopic variceal ligation; HCC, hepatocellular carcinoma; HE, hepatic encephalopathy; HVPG, hepatic venous pressure gradient; ISMN, isosorbide mononitrate; MELD, model for end-stage liver disease; NSBB, non-selective betablocker; PLT, platelet count; PFTE, polytetrafluoroethylene; PSE, portosystemic encephalopathy; PVT, portal vein thrombosis; RCT, randomised controlled trials; TIPS, transjugular intrahepatic portosystemic shunt.