Patients with cirrhosis in ChildPugh class C or those in class B who have persistent bleeding at endoscopy are at high risk

for treatment failure and a poor prognosis Even if they have undergone rescue treatment with a transjugular intrahepatic porto-systemic shunt (TIPS). This study evaluates the earlier use of TIPS in such patients.

Score
Ascites

1
None

2
Mild Mild 34-50

3
Moderate/severe

Encephalopathy None Bilirubin (mol/L) < 34

Marked > 50

Albumin (g/L)
PT(seconds> normal)

> 35
<4

28-35
4-6

< 28
>6

Child class & Survival

Class
1 year Child's A (< 7) Child's B (7-9) Child's C (10+) 82 62 42

% survival
5 years 45 20 20 10 years 25 7 0

Cirrhosis with acute variceal bleed having:

Child Class C (but score <13)
Child Class B (with active bleed on

diagnostic endoscopy)

Age >75 Pregnancy HCC Creatinine >3mg/dL Child score >13 or <7(A) previous pharmacotherapy &/or endoscopic treatment to prevent rebleeding previous TIPS Bleeding from isolated gastric or ectopic varices Total portal-vein thrombosis Heart failure.

Pts randomly assigned, w/in 24 hrs after admission Total 63 pts with cirrhosis & acute variceal bleeding who had been treated with vasoactive drugs + endoscopic therapy were selected Assigned to two groups

1st treated with TIPS w/in 72 hrs after randomization(early-TIPS arm, n=32) 2nd continued on vasoactive drug therapy, followed after 3 to 5 days by treatment with propranolol or nadolol & long-term endoscopic band ligation (EBL), with insertion of a TIPS if needed as rescue therapy (pharmacotherapyEBL arm, n=31)

Vasoactive drugs was continued until pts free of bleeding for at least 24 hrs & preferably up to 5 days Followed by nonselective beta-blocker (propranolol-max 160mg or nadolol-max 240mg) Later isosorbide-5-mononitrate added in incremental dose to a max. of 20mg BD

within 7 to 14 days after initial endoscopic treatment , second, elective session of EBL was performed. EBL sessions were then scheduled every 10 to 14 days until variceal eradication was achieved EBL sessions were performed with the use of multiband devices (6-Shooter Saeed Multi-Band Ligator, Cook, or Speedband SuperView Super 7)

PPIs given till variceal eradication was accomplished After eradication, endoscopic monitoring performed at 1-m, 6-m, & 12m intervals & then annually If varices reappeared, further EBL sessions were initiated

Treatment failure was defined as:

one severe rebleeding episode (i.e.,

requiring a transfusion of >2 units of blood) or two less severe rebleeding episodes,

With TIPS as rescue therapy when necessary

TIPS was performed within 72 hours after diagnostic endoscopy (or, when possible, w/in first 24 hrs) Vasoactive drugs administered until then TIPS revision was performed if there was clinical recurrence of portal hypertension or evidence of TIPS dysfunction on Doppler USG If TIPS dysfunction was confirmed, angioplasty was performed or another stent was placed

Patients were followed until death or liver transplantation up to a maximum of 2 yrs of follow-up or until the end of the study

End points of the study were

failure to control acute bleeding failure to prevent clinically significant

variceal re-bleeding within 1 year after enrollment Mortality at 1year

During a median follow-up of 16 months, rebleeding or failure to control bleeding occurred in 14 patients in the pharmacotherapyEBL group as compared with 1 patient in the early-TIPS group (P = 0.001) The 1-year actuarial probability of remaining free of this end point was 50% in the pharmacotherapyEBL group versus 97% in the early-TIPS group (P < 0.001)

Sixteen patients died- 12 in pharmacotherapyEBL group & 4 in the early-TIPS group- (P = 0.01) The 1-year actuarial survival was- 61% in the pharmacotherapyEBL group versus 86% in the early-TIPS group- (P < 0.001)

Number of days in the intensive care unit and the percentage of time in the hospital during follow-up were significantly higher in the pharmacotherapyEBL group than in the early-TIPS group

In these patients with cirrhosis who were hospitalized for acute variceal bleeding and at high risk for treatment failure, the early use of TIPS was associated with significant reductions in treatment failure and in mortality.