Ligation versus propranolol for the primary prophylaxis of variceal bleeding in cirrhosis

Hepatology. 2004 Jul;40(1):65-72. doi: 10.1002/hep.20284.

Abstract

In this randomized controlled multicenter trial, we compared endoscopic variceal banding ligation (VBL) with propranolol (PPL) for primary prophylaxis of variceal bleeding. One hundred fifty-two cirrhotic patients with 2 or more esophageal varices (diameter >5 mm) without prior bleeding were randomized to VBL (n = 75) or PPL (n = 77). The groups were well matched with respect to baseline characteristics (age 56 +/- 10 years, alcoholic etiology 51%, Child-Pugh score 7.2 +/- 1.8). The mean follow-up was 34 +/- 19 months. Data were analyzed on an intention-to-treat basis. Neither bleeding incidence nor mortality differed significantly between the 2 groups. Variceal bleeding occurred in 25% of the VBL group and in 29% of the PPL group. The actuarial risks of bleeding after 2 years were 20% (VBL) and 18% (PPL). Fatal bleeding was observed in 12% (VBL) and 10% (PPL). It was associated with the ligation procedure in 2 patients (2.6%). Overall mortality was 45% (VBL) and 43% (PPL) with the 2-year actuarial risks being 28% (VBL) and 22% (PPL). 25% of patients withdrew from PPL treatment, 16% due to side effects. In conclusion, VBL and PPL were similarly effective for primary prophylaxis of variceal bleeding. VBL should be offered to patients who are not candidates for long-term PPL treatment.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Actuarial Analysis
  • Adrenergic beta-Antagonists / adverse effects
  • Adrenergic beta-Antagonists / therapeutic use*
  • Esophageal and Gastric Varices / complications
  • Esophageal and Gastric Varices / drug therapy*
  • Esophageal and Gastric Varices / etiology
  • Esophageal and Gastric Varices / surgery*
  • Esophagus / surgery*
  • Female
  • Gastrointestinal Hemorrhage / epidemiology
  • Gastrointestinal Hemorrhage / mortality
  • Gastrointestinal Hemorrhage / prevention & control*
  • Humans
  • Incidence
  • Ligation / adverse effects
  • Liver Cirrhosis / complications*
  • Male
  • Middle Aged
  • Proportional Hazards Models
  • Propranolol / adverse effects
  • Propranolol / therapeutic use*
  • Treatment Outcome

Substances

  • Adrenergic beta-Antagonists
  • Propranolol