Jacob Korula, MD
Is early treatment with transjugular intrahepatic portosystemic shunts (TIPS) better than drug therapy plus endoscopic band ligation (DT-EBL) in high-risk patients with cirrhosis and variceal bleeding?
Randomized controlled trial (RCT). Current Controlled Trials ISRCTN58150114.
≤ 2 years (median 16 mo).
9 centers in Europe.
63 patients ≤ 75 years of age (mean age 51 y, 70% men) who had cirrhosis (Child-Pugh class C disease or class B disease with bleeding at diagnostic endoscopy) and acute esophageal variceal bleeding, and were treated with vasoactive drugs, endoscopic treatment (EBL or endoscopic injection sclerotherapy), and prophylactic antibiotics. Exclusion criteria included hepatocellular carcinoma not meeting transplant criteria, creatinine level > 3 mg/dL (265 µmol/L), previous endoscopic plus pharmacologic treatment to prevent bleeding, previous portosystemic shunt, isolated gastric or ectopic varices bleeding, total portal vein thrombosis, heart failure, and pregnancy.
TIPS using a covered stent, performed ≤ 72 hours after diagnostic endoscopy, and dilated to 8 to 10 mm based on portal-pressure gradient (n = 32); or continued use of vasoactive drugs until bleeding stopped for ≥ 24 hours, followed by propranolol (maximum 160 mg twice daily) or nadolol (maximum 240 mg/d), isosorbide-5-mononitrate (maximum 20 mg twice daily), elective EBL every 10 to 14 days, and proton pump inhibitors until variceal bleeding was eradicated (DT-EBL group, n = 31).
Composite bleeding endpoint (failure to control acute bleeding or prevent clinically significant variceal rebleeding at 1 y). Other outcomes included death and complications.
89% (intention-to-treat analysis).
Early use of TIPS reduced rebleeding or failure to control bleeding and mortality more than DT-EBL (Table). Groups did not differ for hepatic encephalopathy (Table) or other complications.
In patients with cirrhosis and acute variceal bleeding, early use of transjugular intrahepatic portosystemic shunts reduced rebleeding and mortality more than drug treatment plus endoscopic band ligation.
Transjugular intrahepatic portosystemic shunt (TIPS) vs drug therapy plus endoscopic band ligation (DT-EBL) in high-risk patients with cirrhosis and variceal bleeding†
†Abbreviations defined in Glossary. RRR, NNT, CI, and P values (chi-square test) calculated from data in article.
‡Treatment failure at 5 d (3% vs 13%, P = 0.20) or clinically significant rebleeding at 1 y (0% vs 32%, P < 0.001).
Korula J. Early use of transjugular intrahepatic portosystemic shunts improved outcomes in patients with cirrhosis and variceal bleeding. Ann Intern Med. ;153:JC4–6. doi: 10.7326/0003-4819-153-8-201010190-02006
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Published: Ann Intern Med. 2010;153(8):JC4-6.
Gastroenterology/Hepatology, Liver Disease.
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