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evident
Original paper
2010NEJMGastroenterology/Hepatology

Early TIPS

Early use of TIPS in patients with cirrhosis and variceal bleeding

RCTVariceal bleeding

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Overview

In high-risk cirrhosis with acute variceal bleeding, early covered TIPS reduced treatment failure and death versus drugs plus band ligation.

Clinical takeaway

For Child-Pugh C, or Child-Pugh B with persistent bleeding at endoscopy, place a covered TIPS early rather than reserving it for rescue after drugs and banding fail.

Key result

Rebleeding or failure to control bleeding occurred in 1 of 32 with early TIPS versus 14 of 31 with pharmacotherapy-EBL (P=0.001). 1-year actuarial survival, also reported, was 86% versus 61% (P<0.001).

Practice impact

Use early covered TIPS in high-risk acute variceal bleeding instead of waiting for rescue TIPS.

Evidence

Study design

Randomized trial of early polytetrafluoroethylene-covered TIPS versus continued vasoactive-drug therapy followed by a beta-blocker and long-term endoscopic band ligation, with TIPS reserved for rescue.

Enrollment

63

Follow-up

Median follow-up of 16 months.

Geography

Not listed

Clinical question

Does early TIPS reduce treatment failure and death compared with pharmacotherapy plus endoscopic band ligation in high-risk cirrhosis with acute variceal bleeding?

Population

  • 63 patients with cirrhosis and acute variceal bleeding already treated with vasoactive drugs plus endoscopic therapy, randomized within 24 hours after admission.
  • The trial targeted patients at high risk for treatment failure: Child-Pugh class C, or class B with persistent bleeding at endoscopy.

Intervention

Polytetrafluoroethylene-covered stent within 72 hours after randomization (early-TIPS group, 32 patients).

Comparator

Continuation of vasoactive-drug therapy, then after 3 to 5 days propranolol or nadolol plus long-term endoscopic band ligation, with TIPS if needed as rescue therapy (31 patients).

Primary outcome

Lead reported outcome (the abstract does not label a primary end point): rebleeding or failure to control bleeding.

The lead reported composite of rebleeding or failure to control bleeding occurred in 1 of 32 patients with early TIPS versus 14 of 31 with pharmacotherapy-EBL (P=0.001). No effect estimate or confidence interval was reported.

p=0.001

Key results

  • During a median follow-up of 16 months, rebleeding or failure to control bleeding occurred in 14 patients in the pharmacotherapy-EBL group versus 1 patient in the early-TIPS group (P=0.001).
  • The 1-year actuarial probability of remaining free of this composite end point was 50% with pharmacotherapy-EBL versus 97% with early TIPS (P<0.001).
  • Sixteen patients died (12 with pharmacotherapy-EBL and 4 with early TIPS; P=0.01). One-year actuarial survival was 61% versus 86% (P<0.001).
  • Seven patients in the pharmacotherapy-EBL group received rescue TIPS, and four of them died. ICU days and the percentage of time in the hospital during follow-up were higher with pharmacotherapy-EBL.

Harms

  • No significant differences were observed between the two treatment groups with respect to serious adverse events.

Clinical Use

Practice impact

  • In high-risk acute variceal bleeding, use a covered TIPS early rather than as rescue after drugs and banding fail.

Applicability

  • Most applicable to cirrhosis with acute variceal bleeding already treated with vasoactive drugs plus endoscopy, especially Child-Pugh C or Child-Pugh B with persistent bleeding at endoscopy.

Limitations

  • Only 63 patients were randomized.
  • No hazard ratio or confidence interval was reported for the composite end point or death.
  • Rescue TIPS was allowed in the pharmacotherapy-EBL group, so the comparison is early TIPS versus a strategy that includes delayed rescue TIPS.

Common misinterpretations

  • This is not a trial of TIPS for all variceal bleeding; the population was selected for high risk of treatment failure.
  • Early TIPS is not the same as rescue TIPS after failure of drugs and banding.

Related evidence

Villanueva UGIB transfusion trial - Later TrialSort SBP albumin trial - Same Disease

Citation

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;362(25):2370-2379. doi:10.1056/NEJMoa0910102

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.