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Gastroenterology. 2015 Sep;149(3):660-8.e1. doi: 10.1053/j.gastro.2015.05.011. Epub 2015 May 16.

Prevention of Rebleeding From Esophageal Varices in Patients With Cirrhosis Receiving Small-Diameter Stents Versus Hemodynamically Controlled Medical Therapy.

Author information

1
Department of Internal Medicine I, University of Bonn, Bonn, Germany. Electronic address: sauerbruch@uni-bonn.de.
2
Department of Internal Medicine I, University of Bonn, Bonn, Germany; Institute of Clinical Chemistry and Clinical Pharmacology, University of Bonn, Bonn, Germany.
3
Department of Internal Medicine I, University of Ulm, Ulm, Germany; Department of Internal Medicine I, University of Halle, Halle, Germany.
4
Department of Internal Medicine I, University of Halle, Halle, Germany.
5
Department of Internal Medicine II, University of Freiburg, Freiburg, Germany.
6
Department of Internal Medicine I, University of Regensburg, Regensburg, Germany; Department of Visceral Surgery and Medicine, University of Bern, Bern, Switzerland.
7
Klinikum Ludwigsburg, Ludwigsburg, Germany.
8
Department of Gastroenterology, University of Leipzig, Leipzig, Germany.
9
Department of Internal Medicine III, University of Aachen, Aachen, Germany.
10
Department of Hepatology and Gastroenterology, Charité-Universitätsmedizin Berlin, Berlin, Germany.
11
Institute for Medical Biometry, Informatics and Epidemiology, University of Bonn, Bonn, Germany.
12
Department of Internal Medicine I, University of Bonn, Bonn, Germany.
13
Department of Internal Medicine I, University of Bonn, Bonn, Germany; Department of Internal Medicine II, Saarland University, Homburg, Germany.
14
Department of Internal Medicine I, University of Bonn, Bonn, Germany; Medizinische Klinik, Helios Klinikum Siegburg, Siegburg, Germany.

Abstract

BACKGROUND & AIMS:

Patients with cirrhosis and variceal hemorrhage have a high risk of rebleeding. We performed a prospective randomized trial to compare the prevention of rebleeding in patients given a 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 cirrhosis (92% Child class A or B, 70% alcoholic) treated at 10 medical centers in Germany. Patients were assigned randomly more than 5 days after variceal hemorrhage to groups given a small covered transjugular intrahepatic portosystemic stent-shunt (TIPS) (8 mm; 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 an adequate reduction in HVPG (responders) remained on the drugs whereas nonresponders underwent only variceal band ligation. The study was closed 10 months after the last patient was assigned to a group. The primary end point was variceal rebleeding. Survival, safety (adverse events), and quality of life (based on the Short Form-36 health survey) were secondary outcome measures.

RESULTS:

A significantly smaller proportion of patients in the TIPS group had rebleeding within 2 years (7%) than in the medical group (26%) (P = .002). A slightly higher proportion of patients in the TIPS group experienced adverse events, including encephalopathy (18% vs 8% for medical treatment; P = .05). Rebleeding occurred in 6 of 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 nonresponders who received variceal band ligation (31%) (P = .06). Fifteen patients from the medical group (16%) underwent TIPS placement during follow-up evaluation, mainly for refractory ascites. Survival time and quality of life did not differ between both randomized groups.

CONCLUSIONS:

Placement of a small-diameter, covered TIPS was straightforward and prevented variceal rebleeding in patients with Child A or B cirrhosis more effectively than drugs, which often required step-by-step therapy. However, TIPS did not increase survival time or quality of life and produced slightly more adverse events. Clinical Trial no: ISRCTN 16334693.

KEYWORDS:

Advanced Liver Disease; HVPG; Nonselective β-Blocker; TIPS

PMID:
25989386
DOI:
10.1053/j.gastro.2015.05.011
[Indexed for MEDLINE]
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