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

Sauerbruch, Tilman; Mengel, Martin; Dollinger, Matthias; Zipprich, Alexander; Rössle, Martin; Panther, Elisabeth; Wiest, Reiner; Caca, Karel; Hoffmeister, Albrecht; Lutz, Holger; Schoo, Rüdiger; Lorenzen, Henning; Trebicka, Jonel; Appenrodt, Beate; Schepke, Michael; Fimmers, Rolf (2015). Prevention of Rebleeding From Esophageal Varices in Patients With Cirrhosis Receiving Small-Diameter Stents Versus Hemodynamically Controlled Medical Therapy. Gastroenterology, 149(3), pp. 660-668. Elsevier 10.1053/j.gastro.2015.05.011

[img]
Preview
Text
1-s2.0-S0016508515006836-main.pdf - Published Version
Available under License Publisher holds Copyright.

Download (1MB) | Preview

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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Gastro-intestinal, Liver and Lung Disorders (DMLL) > Clinic of Visceral Surgery and Medicine > Gastroenterology

UniBE Contributor:

Wiest, Reiner

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0016-5085

Publisher:

Elsevier

Language:

English

Submitter:

Lilian Karin Smith-Wirth

Date Deposited:

04 Apr 2016 13:42

Last Modified:

07 Apr 2016 10:15

Publisher DOI:

10.1053/j.gastro.2015.05.011

PubMed ID:

25989386

Uncontrolled Keywords:

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

BORIS DOI:

10.7892/boris.77751

URI:

https://boris.unibe.ch/id/eprint/77751

Actions (login required)

Edit item Edit item
Provide Feedback