Upper GI bleed: varices: TIPS prevented more rebleeds than sclerotherapy but caused more encephalopathy.

Clinical bottom line (level 1b)

  1. Patients with a recent bleed from oesophageal varices who had a transjugular intrahepatic portosystemic shunt inserted compared with having a course of sclerotherapy were less likely to rebleed (NNT = 4 at 19 months)
  2. However more patients given TIPS developed encephalopathy (NNH = 3 at 19 months)
  3. There was no clear effect on mortality.
  4. There was no clear difference in the number of treatment failures or complications.
Merli et al: Hepatology 1998; 27: 48-53
Expires October 2002

The study

Unblinded ?concealed randomised trial with intention-to-treat
Setting: 2 acute hospitals, Italy

81 patients (aged mean 59, 72% male) with cirrhosis and active or recent upper GI bleeding from oesophageal varices (confirmed on endoscopy)

Excluded if
  • haemodynamically stable
  • complete portal vein thrombosis
  • previous episode of chronic recurrent hepatic encephalopathy
  • advanced hepatocellular carcinoma
  • previous multiple sessions of endoscopic sclerotherapy
  • on-going pharmacological prophylaxis of rebleeding
  • severe cardiovascular contraindications
  • concomitant morbid conditions with a life expectancy of <1 year
  • bleed >24 weeks ago

Note:
  • Patients were stratified before randomisation based on the time between bleeding and randomisation.

Control Group: (n = 43, 43 analysed): endoscopic sclerotherapy weekly until varices were eradicated
Experimental Group: (n = 38, 38 analysed): transjugular intrahepatic portosystemic shunt (TIPS). Patients had subcutaneous heparin for one month after, unless they had a severe coagulopathy.

100% followed for 19 days
Outcome notes:
  • Rebleeding : haematemesis or melaena occurring 24 hours after haemodynamic stabilisation.
  • Complications : TIPS - pulmonary embolism, cardiac arrest, intrahepatic haematoma, haemolysis; sclerotherapy - oesophageal ulcer or stenosis, aspiration pneumonia, embolic stroke

The evidence

Outcome Time to outcome CEREERRRR
(95% CI)		ARR
(95% CI)		NNT
(95% CI)
Rebleeding 19 months 22
(51.2%)		 9
(23.7%)		 54%
(12% to 76%)		 27.5%
(7.33% to 47.6%)		 4
(2 to 14)
Death 19 months 8
(18.6%)		 9
(23.7%)		 -27%
(-197% to 45%)		 -5.08%
(-22.9% to 12.8%)		 -20
(NNT = 4 to infinity;
NNH = 8 to infinity)
Treatment failures: uncontrolled bleeding at any time, and inability to insert, dilate or replace stent for TIPS. 19 months 12
(27.9%)		 7
(18.4%)		 34%
(-50% to 71%)		 9.49%
(-8.73% to 27.7%)		 11
(NNT = 11 to infinity;
NNH = 4 to infinity)
Moderate or severe hepatic encephalopathy weeks 10
(23.3%)		 21
(55.26%)		 -138%
(-339% to -29%)		 -32.01%
(-52.24% to -11.8%)		 -3
(-8 to -2)
Complications weeks 6
(14.0%)		 4
(10.5%)		 25%
(-147% to 77%)		 3.43%
(-10.8% to 17.66%)		 29
(NNT = 9 to infinity;
NNH = 6 to infinity)

Comments

  1. Patients were randomised in blocks of four.

Citation

  1. Merli M, Salerno F, Riggio O, et al: transjugular Intrahepatic portosystemic shunt versus endoscopic sclerotherapy for the prevention of variceal bleeding in cirrhosis: a randomized multicenter trial. Hepatology 1998; 27: 48-53
Contributor: Chris Ball and Musab Hayatli, October 1999
Reviewer:

Clinical Question.
Patient recent oesophageal variceal bleed
Intervention or Exposure transjugular intrahepatic portosystemic shunt (TIPS)
Comparison sclerotherapy
Outcome rebleeding, death, treatment failure, encephalopathy