Covered vs. uncovered stents for transjugular intrahepatic portosystemic shunt: a randomized controlled trial.
OBJECTIVE
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.
Service d'Hépato-Gastroentérologie, Hôpital Trousseau, CHRU Tours, France. Electronic address: jm.perarnau@chu-tours.fr.
Jean Marc
JM
Perarnau
INSERM, CIC 202, Tours, France; CHRU de Tours, Tours, France.
Amélie
A
Le Gouge
Service d'Hépato-Gastroentérologie, Hôpital Trousseau, CHRU Tours, France; Université François-Rabelais de Tours, PRES Centre-Val de Loire Université, Tours, France.
Charlotte
C
Nicolas
Service d'Hépato-Gastroentérologie, Hôpital Trousseau, CHRU Tours, France.
Louis
L
d'Alteroche
Service d'Hépato-Gastroentérologie, Hôpital de la Conception, Marseille, France.
Patrick
P
Borentain
Service d'Hépato-Gastroentérologie, Hôpital Paul Brousse, Paris, France.
Faouzi
F
Saliba
Service d'Hépato-Gastroentérologie, CHRU Dijon, France.
Anne
A
Minello
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.
Rodolphe
R
Anty
Service d'Hépato-Gastroentérologie, CHRU Poitiers, France.
Carine
C
Chagneau-Derrode
Service d'Hépato-Gastroentérologie, CHRU Bordeaux, France.
Pierre Henri
PH
Bernard
Service d'Hépato-Gastroentérologie, CHRU Clermont-Ferrand, France.
Armand
A
Abergel
Service d'Hépato-Gastroentérologie, CHRU Caen, France.
Isabelle
I
Ollivier-Hourmand
Service d'Hépato-Gastroentérologie, CHRU Nantes, France.
Jérome
J
Gournay
Service d'Echographie Hôpital Trousseau, CHRU Tours, France.
Jean
J
Ayoub
Service d'information médicale, épidémiologie et économie de la santé, CHRU Bretonneau, Tours, France.
Christophe
C
Gaborit
Service d'information médicale, épidémiologie et économie de la santé, CHRU Bretonneau, Tours, France.
Emmanuel
E
Rusch
INSERM, CIC 202, Tours, France; CHRU de Tours, Tours, France; Université François-Rabelais de Tours, PRES Centre-Val de Loire Université, Tours, France.
Bruno
B
Giraudeau
D000368:Aged; D001201:Ascites / Q000209:etiology / Q000601:surgery; D006528:Carcinoma, Hepatocellular / Q000209:etiology; D004932:Esophageal and Gastric Varices / Q000209:etiology / Q000601:surgery*; D005260:Female; D006501:Hepatic Encephalopathy / Q000209:etiology; D006801:Humans; D006975:Hypertension, Portal / Q000150:complications / Q000601:surgery; D053208:Kaplan-Meier Estimate; D008113:Liver Neoplasms / Q000209:etiology; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D019168:Portasystemic Shunt, Transjugular Intrahepatic / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D012008:Recurrence; D016037:Single-Blind Method; D015607:Stents / Q000009:adverse effects; D016896:Treatment Outcome
Ascites; Cirrhosis; Hepatic encephalopathy; Hydrothorax; Portal hypertension; Stent dysfunction; Variceal bleeding prevention