Upper GI bleed: varices: TIPS reduced variceal rebleeding better than sclerotherapy.

Clinical bottom line (level 1b)

Patients with cirrhosis and severe bleeding from oesophageal varices who received TIPS compared with endoscopic sclerotherapy, were less likely to rebleed from their varices (NNT = 3 at 1.5 years) .
There was no clear effect on mortality or development of encephalopathy.

Cello et al: Annals of Internal Medicine 1997; 126: 858-865

Expires July 2003

The study

Unblinded ?concealed randomised trial with intention-to-treat
Setting: three teaching hospitals, USA

49 patients (aged range 34 to 73 years; mean 47, 73% male) cirrhosis and massive or submassive bleeding (systolic blood pressure <80 mmHg, or postural vital signs changes) from endoscopically-documented bleeding oesophageal varices (>1 cm diameter with cherry red spots, haematocystic spots or red wale sign)

Excluded if

prisoners
aged <18 or >75
refused blood products
gastric variceal bleeding
MI on ECG, or CVA within three months
pO2 <70 mmHg, pH <7.2, creatinine >221 ľ mol/l PTT >5s of control after FFP, bilirubin >7 mg/dl or platelets <50 x10 ⁹ /l
cancer
HIV, sepsis, pneumonia or peritonitis
alcoholic hepatitis, stage IV encephalopathy
thrombosis of portal, hepatic or inferior vena cava on doppler ultrasound

Control Group: (n = 25, 25 analysed): repeated sclerotherapy every 2 to 7 days in hospital, then weekly with ethanolamine oleate
Experimental Group: (n = 24, 24 analysed): transjugular intrahepatic portosystemic shunt inserted within 48 hours of randomisation (stent used, target portal to hepatic vein pressure gradient of 12 mmHg or less achieved in all cases). After stenting, persisting varices were occluded with embolisation coils.
All patients received endoscopic sclerotherapy at the initial session.
100% followed for 1.5 years
Outcome notes:

new or worsening encephalopathy : asterixis, disorientation, agitation, somnolence or coma

The evidence

Outcome	Time to outcome	CER	EER	RRR (95% CI)	ARR (95% CI)	NNT (95% CI)
death	30 days	4 (16.0%)	5 (20.8%)	-30% (-328% to 60%)	-4.83% (-26.5% to 16.9%)	-21 (NNT = 6 to infinity; NNH = 4 to infinity)
rebleed	1.5 years	12 (48.0%)	3 (12.5%)	74% (19% to 92%)	35.5% (11.9% to 59.1%)	3 (2 to 8)
new or worsening encephalopathy	1.5 years	11 (44.0%)	12 (50.0%)	-14% (-106% to 37%)	-6.00% (-33.9% to 21.9%)	-17 (NNT = 5 to infinity; NNH = 3 to infinity)
death	1.5 years	8 (32.0%)	8 (33.3%)	-4% (-133% to 53%)	-1.33% (-27.6% to 24.9%)	-75 (NNT = 4 to infinity; NNH = 4 to infinity)

Patients in the TIPS group had higher pre-treatment transfusion requirements and worse Pugh scores (9 v 7.8).

Six patients given sclerotherapy crossed to TIPS for control of bleeding. One TIPS patient crossed to sclerotherapy for technical failure.

18% of TIPS stents were occluded and required angioplasty.

Health care costs were similar (~$28, 000).

Comments

The study is too small to demonstrate any effect on mortality or encephalopathy.
Likewise, the study was not large enough to show any difference in the number of GI bleeds from any source, nor in transfusion requirements.
There was no difference in the incidence of encephalopathy, BUT this was not assessed blind and was based on clinical judgement alone. However, a review of six earlier studies shows significant reduction in variceal bleeding at the cost of increased encephalopathy without an improved survival.
TIPS is primarily used as a rescue therapy

Citation

Cello JP, et al: Endoscopic sclerotherapy compared with percutaneous transjugular intrahepatic portosystemic shunt after initial sclerotherapy in patients with acute variceal hemorrhage. A randomized, controlled trial. Annals of Internal Medicine 1997; 126: 858-865

Contributor: Alan Townsend, Sharon Straus and Chris Ball, July 2000
Reviewer: Zoltan Bodnar

_{Clinical Question.}

_Patient	_{cirrhosis and severe bleeding from oesophageal varices}
_{Intervention or Exposure}	_TIPS
_Comparison	_{sclerotherapy}
_Outcome	_{rebleeding and death}