Early TIPS for variceal hemorrhage
Trial question
What is the role of early use of TIPS in patients with cirrhosis who are hospitalized for acute variceal bleeding and at high risk for treatment failure?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
30.0% female
70.0% male
N = 63
63 patients (19 female, 44 male)
Inclusion criteria: patients with cirrhosis and acute variceal bleeding who had been treated with vasoactive drugs plus endoscopic therapy
Key exclusion criteria: age > 75 years, pregnancy, HCC that did not meet the Milano criteria for transplantation, previous pharmacologic therapy combined with endoscopic treatment to prevent rebleeding, previous use of a portosystemic shunt or TIPS, bleeding from isolated gastric or ectopic varices, total portal vein thrombosis, and HF
Interventions
N=32 early TIPS implantation (treatment with a PTFE-covered stent within 72 hours after randomization)
N=31 vasoactive drugs and endoscopic band ligation (continuation of vasoactive-drug therapy, followed after 3 to 5 days by treatment with propranolol or nadolol and long-term endoscopic band ligation)
Primary outcome
Freedom from rebleeding or failure to control bleeding
97
50
97.0 %
72.8 %
48.5 %
24.3 %
0.0 %
Early TIPS
implantation
Vasoactive drugs and endoscopic band
ligation
Significant
increase ▲
NNT = 2
Significant increase in freedom from rebleeding or failure to control bleeding (97% vs. 50%; ARR 47, 95% CI 25 to 69)
Secondary outcomes
Significant increase in the rate of 1-year actuarial survival (86% vs. 61%; ARR 25, 95% CI 2 to 48)
Significant increase in days in the ICU (3.6 days vs. 8.6 days; AD 5 days, 95% CI 1.19 to 8.81)
Significant decrease in median time in hospital during follow-up (4% vs. 15%; RR 0.27, 95% CI 0.05 to 0.49)
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In patients with cirrhosis and acute variceal bleeding who had been treated with vasoactive drugs plus endoscopic therapy, early TIPS implantation was superior to vasoactive drugs and endoscopic band ligation with respect to freedom from rebleeding or failure to control bleeding.
Reference
Garcia-Pagan 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.
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