The GAVAPROSEC trial - J of Hepatology - Jan.26

The GAVAPROSEC trial provides critical randomized evidence addressing the management of acute gastric variceal bleeding (GVB) in patients with cirrhosis. Gastric variceal bleeding, particularly from fundal gastric varices (GOV2) or isolated gastric varices (IGV1), is a severe and life-threatening complication of portal hypertension, associated with high rebleeding rates and mortality. Despite guidelines recommending endoscopic glue injection for acute hemostasis, the optimal strategy for secondary prophylaxis has remained unclear due to limited robust evidence.

The trial investigated the role of pre-emptive transjugular intrahepatic portosystemic shunt (TIPS) placement within 72 hours after stabilization in patients with acute gastric variceal bleeding. The results demonstrated that pre-emptive TIPS significantly improved rebleeding-free survival compared to standard strategies, which often involve glue obliteration combined with non-selective beta blockers. Importantly, the study found no increase in the incidence of hepatic encephalopathy, a common concern with TIPS procedures. Although no definitive overall survival benefit was observed, the high crossover rate to TIPS in the control group likely diluted the statistical power to detect a survival advantage.

The findings of the GAVAPROSEC trial emphasize the limitations of glue-based strategies, which are associated with high rebleeding rates and depend on technical expertise that may not be uniformly available. By contrast, pre-emptive TIPS offers a more effective approach to secondary prophylaxis in this high-risk population. The trial's results support the consideration of pre-emptive TIPS as a first-line strategy after initial stabilization of gastric variceal bleeding, provided that patient selection and local expertise are carefully considered.

In conclusion, the GAVAPROSEC trial represents a significant advancement in the management of acute gastric variceal bleeding. It provides strong evidence supporting the use of pre-emptive TIPS to improve clinical outcomes, particularly rebleeding-free survival, in a population with historically poor prognoses. This trial is likely to influence future guidelines and clinical practice, offering a more standardized approach to this challenging condition.