article209

Early TIPS

"Early Use of TIPS in Patients with Cirrhosis and Variceal Bleeding".

The New England Journal of Medicine. 2010. 362:2370-2379.
PubMed • Full text • PDF

1 Clinical Question
2 Bottom Line
3 Major Points
4 Guidelines
5 Design
6 Population
6.1 Inclusion Criteria
6.2 Exclusion Criteria
6.3 Baseline Characteristics
7 Interventions
8 Outcomes
8.1 Primary Outcome
8.2 Secondary Outcomes
9 Funding
10 Further Reading

Clinical Question

In patients with Child-Pugh class C cirrhosis or class B with persistent endoscopic bleeding, does early use of TIPS with e-PTFE–covered stents improve outcomes compared to standard therapy with vasoactive drugs plus endoscopic therapy?

Bottom Line

In patients with cirrhosis and acute variceal bleeding at high risk for treatment failure, early use of TIPS with e-PTFE–covered stents significantly reduces treatment failure and mortality with no increase in risk of hepatic encephalopathy.

Major Points

The study investigated whether early initiation of TIPS improves outcomes in patients with cirrhosis and variceal bleeding who are at high risk for failure of standard treatment, which consists of vasoactive drugs and endoscopic band ligation. The results showed a significant reduction in rebleeding and mortality rates among patients receiving TIPS.

Guidelines

As of August 2017, guidelines have not been published that reflect the results of this trial.

Design

Multicenter, randomized, controlled trial
N=63 patients with cirrhosis and acute variceal bleeding
Pharmacotherapy-EBL group (n=31)
Early-TIPS group (n=32)
Setting: 9 European centers
Enrollment: May 2004 to March 2007
Primary follow-up: median 16 months
Analysis: Intention-to-treat

Population

Inclusion Criteria
Cirrhosis with acute esophageal variceal bleeding treated with vasoactive drugs, endoscopic treatment, and prophylactic antibiotics
Child–Pugh class C disease or class B with active bleeding at diagnostic endoscopy
Exclusion Criteria
Age >75, pregnancy, hepatocellular carcinoma outside Milano criteria, creatinine >3 mg/dL, Child–Pugh score >13, previous portosystemic shunt, bleeding from isolated gastric or ectopic varices, total portal-vein thrombosis, heart failure
Baseline Characteristics
No significant between-group differences at baseline

Interventions

Pharmacotherapy-EBL group: continuation of vasoactive-drug therapy followed by propranolol or nadolol and long-term EBL, using TIPS as rescue therapy if needed
Early-TIPS group: early use of TIPS within 72 hours with e-PTFE–covered stents

Outcomes

Primary Outcome
Failure to control bleeding or prevention of clinically significant variceal rebleeding within 1 year
Secondary Outcomes
Mortality at 6 weeks and 1 year
Development of liver-related complications
Number of days in intensive care and percentage of follow-up days spent in hospital

Funding

Partially funded by grants from multiple institutions including Instituto de Salud Carlos III (Spain), Ministerio de Educación y Ciencia (Spain), University Hospital Center of Toulouse, Fund for Scientific Research — Flanders, and an educational grant from Gore.