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Gastroenterology in critical care · Variceal bleeding

Early TIPS randomised trial

Early use of TIPS in patients with cirrhosis and variceal bleeding

Early TIPS trial design and results
Design Randomised controlled trial
Treatment Early TIPS with a polytetrafluoroethylene-covered stent within 72 hours of randomisation, itself within 24 hours of admission
Control Pharmacotherapy plus endoscopic band ligation
Population 63 patients with cirrhosis hospitalised for acute variceal bleeding at high risk of treatment failure — Child-Pugh class C, or class B with persistent bleeding at endoscopy — all treated first with vasoactive drugs plus endoscopic therapy
Follow-up Median 16 months
Primary endpoint Failure to control bleeding or rebleeding
Result Rebleeding or failure to control bleeding occurred in 14 patients in the pharmacotherapy plus band ligation group versus 1 patient in the early TIPS group, with significant reductions in treatment failure and mortality.
Secondary endpoints Mortality, hepatic encephalopathy, transfusion requirement

In these patients with cirrhosis who were hospitalized for acute variceal bleeding and at high risk for treatment failure, the early use of TIPS was associated with significant reductions in treatment failure and in mortality.

The trial authors, in the published abstract

How it has aged

A dramatic effect in a small, carefully selected high-risk group, and the basis for pre-emptive TIPS in current guidelines. The selection criteria are doing enormous work, and the trial says nothing about lower-risk bleeders.

Publications

Early use of TIPS in patients with cirrhosis and variceal bleeding

García-Pagán JC, Caca K, Bureau C, et al. Early use of TIPS in patients with cirrhosis and variceal bleeding. N Engl J Med 2010 Jun 24;362(25):2370-9.

  • Rebleeding or failure to control bleeding in 1 versus 14 patients
  • Significant mortality reduction
  • Only 63 highly selected patients