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Early TIPS improves outcomes in cirrhotic patients with acute variceal bleeding

Clinical Question:
Does the earlier use of a transjugular intrahepatic portosystemic shunt improve the prognosis in patients with severe cirrhosis and acute variceal bleeding?

Bottom Line:
In patients with advanced cirrhosis and acute variceal bleeding, the early use of a transjugular intrahepatic portosystemic shunt (TIPS) prevents rebleeding, as well as uncontrolled bleeding, and reduces mortality without increasing the frequency or severity of hepatic encephalopathy. (LOE = 1b)

Garcia-Pagan JC, Caca K, Bureau C, et al, for the Early TIPS (Transjugular Intrahepatic Portosystemic Shunt) Cooperative Study Group. Early use of TIPS in patients with cirrhosis and variceal bleeding. N Engl J Med 2010;362(25):2370-2379.  [PMID:20573925]

Study Design:
Randomized controlled trial (nonblinded)

Industry + govt


Inpatient (any location) with outpatient follow-up

In this multicenter trial, investigators enrolled cirrhotic patients with acute esophageal variceal bleeding who were being treated with vasoactive drugs (terlipressin, somatostatin, or octreotide) and endoscopic therapy. All patients had either Child-Pugh class C cirrhosis or class B disease with active bleeding at diagnostic endoscopy. Those with renal failure, hepatocellular carcinoma, portal vein thrombosis, a Child-Pugh score greater than 13, or previous portosystemic shunt use were excluded. Using concealed allocation, 32 of 63 enrolled patients were randomized to receive early TIPS within 72 hours after diagnostic endoscopy. The remaining 31 patients received standard therapy (n = 31), which consisted of the continuation of vasoactive drugs for up to 5 days, followed by treatment with either propranolol up to 160 mg twice daily or nadolol up to 240 mg daily, the addition of isosorbide-5-mononitrate up to 20 mg twice daily, and endoscopic band ligation every 10 days to 14 days until varices were eradicated. In the standard therapy group, TIPS was only performed for rescue therapy as needed. The majority of patients in the study had alcoholic cirrhosis and the 2 groups had similar baseline characteristics. Analysis was by intention to treat. After a median follow-up of 16 months, the primary composite outcome of rebleeding or failure to control bleeding occurred in 14 patients in the standard therapy group as compared with only 1 patient in the early TIPS group (P < .001). At 1 year, the probability of remaining free of this end point was higher in the early TIPS group (97% vs 50% in the standard therapy group; P = .001). You would need to treat 2 patients with early TIPS to prevent one episode of rebleeding or uncontrolled bleeding (number needed to treat [NNT] = 2.1; 95% CI, 1.4-4.0). In addition, the 1-year survival rate was higher in the early TIPS group (86% vs 61%; P = .001; NNT = 4; 2.1-50). There were no significant differences in adverse events between the 2 groups, including frequency and severity of hepatic encephalopathy and development of new or worsening ascites.


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