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J Hepatol. 2014 May;60(5):962-8. doi: 10.1016/j.jhep.2014.01.015. Epub 2014 Jan 27.

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

Author information

1
Service d'Hépato-Gastroentérologie, Hôpital Trousseau, CHRU Tours, France. Electronic address: jm.perarnau@chu-tours.fr.
2
INSERM, CIC 202, Tours, France; CHRU de Tours, Tours, France.
3
Service d'Hépato-Gastroentérologie, Hôpital Trousseau, CHRU Tours, France; Université François-Rabelais de Tours, PRES Centre-Val de Loire Université, Tours, France.
4
Service d'Hépato-Gastroentérologie, Hôpital Trousseau, CHRU Tours, France.
5
Service d'Hépato-Gastroentérologie, Hôpital de la Conception, Marseille, France.
6
Service d'Hépato-Gastroentérologie, Hôpital Paul Brousse, Paris, France.
7
Service d'Hépato-Gastroentérologie, CHRU Dijon, France.
8
Institut National de la Santé et de la Recherche Médicale (INSERM), U1065, Team 8, "Hepatic Complications in Obesity", Nice F-06204, Cedex 3, France; Centre Hospitalier Universitaire of Nice, Digestive Center, Nice F-06202, Cedex 3, France; University of Nice-Sophia-Antipolis, Faculty of Medecine, Nice F-06107, Cedex 2, France.
9
Service d'Hépato-Gastroentérologie, CHRU Poitiers, France.
10
Service d'Hépato-Gastroentérologie, CHRU Bordeaux, France.
11
Service d'Hépato-Gastroentérologie, CHRU Clermont-Ferrand, France.
12
Service d'Hépato-Gastroentérologie, CHRU Caen, France.
13
Service d'Hépato-Gastroentérologie, CHRU Nantes, France.
14
Service d'Echographie Hôpital Trousseau, CHRU Tours, France.
15
Service d'information médicale, épidémiologie et économie de la santé, CHRU Bretonneau, Tours, France.
16
INSERM, CIC 202, Tours, France; CHRU de Tours, Tours, France; Université François-Rabelais de Tours, PRES Centre-Val de Loire Université, Tours, France.

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.

KEYWORDS:

Ascites; Cirrhosis; Hepatic encephalopathy; Hydrothorax; Portal hypertension; Stent dysfunction; Variceal bleeding prevention

PMID:
24480619
DOI:
10.1016/j.jhep.2014.01.015
[Indexed for MEDLINE]

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