Prevention of Rebleeding from Esophageal Varices in Patients with Cirrhosis Receiving Small-diameter Stents vs Hemodynamically Controlled Medical Therapy. Sauerbruch T, Mengel M, Dollinger M, Zipprich A, Rössle M, Panther E, Wiest R, Caca K, Hoffmeister A, Lutz H, Schoo R, Lorenzen H, Trebicka J, Appenrodt B, Schepke M, Fimmers R; German Study Group for Prophylaxis of Variceal Rebleeding. Gastroenterology. 2015 May 16. [Epub ahead of print]
BACKGROUND: &Aims: Patients with liver cirrhosis and variceal hemorrhage have a high risk of rebleeding. We performed a prospective, randomized trial to compare prevention of rebleeding in patients given small-diameter covered stent vs those given hepatic venous pressure gradient (HVPG)-based medical therapy prophylaxis.
METHODS: We performed an open-label study of patients with liver cirrhosis (92% Child class A or B, 70% alcoholic) treated at 10 medical centers in Germany. Patients were randomly assigned more than 5 days after variceal hemorrhage to groups given a small intrahepatic stent shunt (cTIPS, 8mm; n=90), or medical reduction of portal pressure (propranolol and isosorbide-5-mononitrate; n=95). HVPG was determined at the time patients were assigned to groups (baseline) and 2 weeks later. In the medical group, patients with adequate reduction in HVPG (responders) remained on the drugs whereas non-responders underwent only variceal band ligation. The study was closed 10 months after the last patient was assigned to a group. The primary endpoint was variceal rebleeding. Survival, safety (adverse events), and quality of life (based on the SF-36 health survey) were secondary outcome measures.RESULTS: A significantly smaller proportion of patients in the TIPS group had rebleeding within 2 y (7%) than the medical group (26%) (P=.002). A slightly higher proportion of patients in the TIPS group had adverse events, including encephalopathy (18% vs 8% for medical treatment, P=.05). Rebleeding occurred in 6/23 patients (26%) receiving medical treatment before hemodynamic control was possible. Per-protocol analysis showed that rebleeding occurred in a smaller proportion of the 32 responders (18%) than in non-responders who received variceal band ligation (31%) (P=.06). Fifteen patients from the medical group (16%) underwent TIPS placement during follow-up, mainly for refractory ascites. Survival time and quality of life did not differ between both randomized groups.CONCLUSIONS: Placement of a small-diameter cTIPS was straightforward and prevented variceal rebleeding in patients with Child A or B cirrhosis more effectively than drugs, which often required a step-by-step therapy. However, TIPS did not increase survival time or quality of life and produced slightly more adverse events. Leggi l’articolo
