Primary prophylaxis of gastric variceal bleeding comparing cyanoacrylate injection and beta-blockers: a randomized controlled trial

Abstract

Background & aims: Gastric variceal bleeding is severe and is associated with high mortality. We compared the efficacy of cyanoacrylate injection and beta-blockers in primary prophylaxis of gastric variceal bleeding.

Methods: Cirrhotics with large gastroesophageal varices type 2 with eradicated esophageal varices or large isolated gastric varix type 1, who had never bled from gastric varix, were randomised to cyanoacrylate injection (Group I, n=30), beta-blockers (Group II, n=29) or no treatment (Group III, n=30). Primary end-points were bleeding from gastric varix or death.

Results: The actuarial probability of bleeding from gastric varices over a median follow-up of 26 months was 13% in Group I, 28% in Group II (p=0.039), and 45% in Group III (p=0.003). The actuarial probability of survival was higher in the cyanoacrylate compared to the no-treatment group (90% vs. 72%, p=0.048). The median hepatic venous pressure gradient (HVPG) was increased in Group I (14-15 mm Hg, p=0.001) and III (14-16 mm Hg, p=0.001) but decreased in Group II (14 to 12 mm Hg, p=0.001) during follow-up. Size of gastric varix >20 mm, a MELD score ≥17, and presence of portal hypertensive gastropathy predicted 'high risk' of first bleeding from gastric varices.

Conclusions: Primary prophylaxis is recommended in patients with large and high risk gastric varices to reduce the risk of first bleeding and mortality. Cyanoacrylate injection is more effective than beta-blocker therapy in preventing first gastric variceal bleeding.

Trial registration: ClinicalTrials.gov NCT00905996.