Covered vs. uncovered stents for transjugular intrahepatic portosystemic shunt: a randomized controlled trial.

Abstract

BACKGROUND & AIMS:

The first studies comparing covered stents (CS) and bare stents (BS) to achieve Transjugular Intrahepatic Portosystemic Shunt (TIPS) were in favor of CS, but only one randomized study has been performed. Our aim was to compare the primary patency of TIPS performed with CS and BS.

METHODS:

The study was planned as a multicenter, pragmatic (with centers different in size and experience), randomized, single-blinded (with blinding of patients only), parallel group trial. The primary endpoint was TIPS dysfunction defined as either a portocaval gradient ⩾12mmHg, or a stent lumen stenosis ⩾50%. A transjugular angiography with portosystemic pressure gradient measurement was scheduled every 6months after TIPS insertion.

RESULTS:

137 patients were randomized: 66 to receive CS, and 71 BS. Patients who were found to have a hepato-cellular carcinoma, or whose procedure was cancelled were excluded, giving a sample of 129 patients (62 vs. 67). Median follow-up for CS and BS were 23.6 and 21.8months, respectively. Compared to BS, the risk of TIPS dysfunction with CS was 0.60 95% CI [0.38-0.96], (p=0.032). The 2-year rate of shunt dysfunction was 44.0% for CS vs. 63.6% for BS. Early post TIPS complications (22.4% vs. 34.9%), risk of hepatic encephalopathy (0.89 [0.53-1.49]) and 2-year survival (70% vs. 67.5%) did not differ in the two groups. The 2-year cost/patient was 20k€ [15.9-27.5] for CS vs. 23.4k€ [18-37] for BS (p=0.52).

CONCLUSIONS:

CS provided a significant 39% reduction in dysfunction compared to BS. We did not observe any significant difference with regard to hepatic encephalopathy or death.

• Authors: Jean Marc Perarnau, Amélie Le Gouge, Charlotte Nicolas, Louis d'Alteroche, Patrick Borentain, Faouzi Saliba, Anne Minello, Rodolphe Anty, Carine Chagneau-Derrode, Pierre Henri Bernard, Armand Abergel, Isabelle Ollivier-Hourmand, Jérome Gournay, Jean Ayoub, Christophe Gaborit, Emmanuel Rusch, Bruno Giraudeau, STIC-TIPS group
• Journal: Journal of hepatology (J Hepatol) Vol. 60 Issue 5 Pg. 962-8 (May 2014) ISSN: 1600-0641 [Electronic] Netherlands
• PMID: 24480619 (Publication Type: Journal Article, Multicenter Study, Pragmatic Clinical Trial, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2014 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

Topics

• Aged
• Ascites (etiology, surgery)
• Carcinoma, Hepatocellular (etiology)
• Esophageal and Gastric Varices (etiology, surgery)
• Female
• Hepatic Encephalopathy (etiology)
• Humans
• Hypertension, Portal (complications, surgery)
• Kaplan-Meier Estimate
• Liver Neoplasms (etiology)
• Liver Transplantation
• Male
• Middle Aged
• Portasystemic Shunt, Transjugular Intrahepatic (adverse effects, instrumentation, methods)
• Recurrence
• Single-Blind Method
• Stents (adverse effects)
• Treatment Outcome