Comparison of endoscopic variceal ligation and nadolol plus isosorbide-5-mononitrate in the prevention of first variceal bleeding in cirrhotic patients.

Background: Both drug therapy and banding ligation are widely used in the prevention of first variceal bleeding. This study compared the efficacy and safety of band ligation vs. combination of beta-blocker and nitrate for the prevention of first bleeding in patients with cirrhosis and high-risk esophageal varices.

Methods: A total of 61 patients with cirrhosis with moderate or severe esophageal varices associated with red color signs but without history of variceal bleeding were randomized to band ligation (30 patients) or treatment with nadolol plus isosorbide-5-mononitrate (ISMN) (31 patients). In the ligation group, multiband ligator with 4 elastic bands was applied during each session. Ligation was repeated at intervals of 4 weeks until variceal obliteration was achieved. In the combination group, the dose of nadolol was sufficient to reduce the pulse rate by 25%. ISMN 1 tablet 20 mg qd or bid was administered.

Results: Both groups were similar in baseline characteristics. In the ligation group, variceal obliteration was achieved in 24 patients (80%), at a mean of 3.2 +/- 0.9 ligation sessions and 11.7 +/- 3.2 elastic bands. In the combination group, the mean daily doses of nadolol and ISMN administered were 40 +/- 14 mg and 40 +/- 12 mg, respectively. During a median follow-up of approximately 23 months, 5 patients (17%) in the ligation group and 8 patients (26%) in the combination group had upper-gastrointestinal bleeding (p = 0.53). Esophageal variceal bleeding occurred in 3 patients (10%) in the ligation group and 6 (19%) in the combination group (p = 0.42). By multivariate Cox analysis, presence of ascites was the only factor predictive of variceal bleeding. Minor complications were noted in 5 patients (17%) in the ligation group and 3 (10%) in the combination group (p = 0.47). Eight patients in the ligation group and 6 in the combination group died (p = 0.49). One (3%) patient in the ligation group and 3 (10%) in the combination group died of uncontrollable variceal bleeding.

Conclusion: Our preliminary results suggest that endoscopic variceal ligation is similar to the combination of nadolol plus ISMN with regard to effectiveness and safety in the prevention of first variceal bleeding in patients with cirrhosis.