Upper GI bleed: varices: TIPS increased rehospitalisation without reducing rebleeding or death

Clinical bottom line (level 1b)

  1. Patients with cirrhosis and a recent bleed from oesophageal varices who had a transjugular intrahepatic portosystemic shunt (TIPS) inserted compared with sclerotherapy were not clearly less likely to rebleed, develop hepatic encephalopathy or die.
  2. Patients who had TIPS compared with sclerotherapy were more likely to be rehospitalised (NNH = 2 at 2.7 years) .
Sanyal et al: Annals of Internal Medicine 1997; 126: 849-857
Expires October 2002

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: university hospital, USA

80 patients (aged mean 50, 66% male) with cirrhosis and an acute variceal haemorrhage roughly 10 days previously (defined as coffee-ground vomit, red blood or melaena, and a fall in Hb of at least 2 g/dl, and confirmed on endoscopy) who were now clinically stable

Excluded if
  • portal vein thrombosis
  • hepatoma on ultrasound
  • end-stage cancer or systemic diseases limiting life span to < 1 year
  • pregnancy
  • history of non-compliance with treatment


    • Note:
  • Beta-blockers were discontinued before study entry.

Control Group: (n = 39, 39 analysed): sclerotherapy every 2 to 3 weeks until varices were obliterated. Patients were then endoscoped / followed every 3 to 6 months.
Experimental Group: (n = 41, 41 analysed): transjugular intrahepatic portosystemic shunt (TIPS)

96% followed for 2.7 years mean

The evidence

Outcome Time to outcome CEREERRRR
(95% CI)		ARR
(95% CI)		NNT
(95% CI)
death 2.7 years 7
(18.0%)		 12
(29.3%)		 -63%
(-270% to 28%)		 -11.3%
(-29.7% to 7.09%)		 -9
(NNT = 3 to infinity;
NNH = 14 to infinity)
rebleeding 2.7 years 10
(25.6%)		 10
(24.4%)		 5%
(-100% to 55%)		 1.25%
(-17.7% to 20.2%)		 80
(NNT = 6 to infinity;
NNH = 5 to infinity)
hepatic encephalopathy 2.7 years 5
(12.8%)		 12
(29.3%)		 -130%
(-490% to 11%)		 -16.5%
(-33.9% to 0.99%)		 -6
(NNT = 3 to infinity;
NNH = 100 to infinity)

  • Rehospitalisatoin was not clearly different overall between the two groups (data not given), although rehospitalisation secondary to encephalopathy was greater in the TIPS group (NNH=2; 95% CI 2 to 4)

    • Comments

    1. TIPS is not recommended on the basis of current data for the secondary prevention of variceal bleeding, because of its worse cost/benefit profile compared to other treatments. TIPS should be used primarily as a salvage therapy when endoscopic therapy failed.

    Citation

    1. Sanyal AJ, Freedman AM, Luketic VA, et al: Transjugular intrahepatic portosystemic shunts compared with endoscopic sclerotherapy for the prevention of recurrent variceal haemorrhage: a randomized, controlled trial. Annals of Internal Medicine 1997; 126: 849-857
    Contributor: Chris Ball and Musab Hayatli, October 1999
    Reviewer: Horand Meier

    Clinical Question.
    Patient cirrhosis and recent bleed from oesophageal varices
    Intervention or Exposure TIPS
    Comparison sclerotherapy
    Outcome death, rehospitalisation, encephalopathy