Covered transjugular intrahepatic portosystemic stent shunt versus optimezed medical treatment for the secondary prevention of variceal bleeding in cirrhosis

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Patients with liver cirrhosis frequently develop dilated venous collaterals in the esophagus, i.e. esophageal varices. Bleeding from such varices is one of the major causes of death in these patients. After an initial hemorrhage, rebleeding is frequent (70 - 80 %). Thus, rebleeding prophylaxis is mandatory. Each of the current therapeutic options for these patients (endoscopic ligation of varices, drug treatment aimed at lowering the blood pressure inside the varices, and the insertion of a decompressive uncovered metal stent between the hepatic vein and a branch of the portal vein (TIPS)) carries major disadvantages. The present randomized, controlled, multicenter trial compares two regimens for rebleeding prophylaxis: the insertion of a newly developed, covered TIPS-stent (group A) and a hemodynamically monitored optimized medical treatment (drug treatment with propranolol plus isosorbide-5-mononitrate which will be replaced by endoscopic ligation of varices in case of an insufficient reduction of the portal pressure) (group B). Presumably, a small diameter covered TIPS induces sufficient portal pressure reduction for rebleeding prevention, but carries a much lower risk of typical problems after TIPS insertion (liver failure, hepatic encephalopathy, TIPS dysfunction). Page 4 of 14 This study evaluates the hypothesis that these advantages translate into a lower rebleeding rate (primary endpoint) when compared with optimized standard treatment.