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Background: Bleeding from esophageal varices is one of the most frequent and deadly complications of liver cirrhosis, with six-week mortality rates as high as 30%. The estimation of portal pressure by means of hepatic venous pressure gradient (HVPG) measurement remains the single most accurate predictor of bleeding in individual patients. An increasing number of studies have reported a greater reduction of HVPG using carvedilol compared to the current standard of care, propranolol; however, there are still no clinical trials comparing carvedilol to propranolol head-to-head for the prophylaxis of variceal bleeding.
Aims: To compare carvedilol versus propranolol for the prevention of a first variceal bleed (primary prophylaxis) in patients with cirrhosis and esophageal varices.
Methods: This is a proposed design and protocol for a multicenter, randomized, active-controlled, double-blind, parallel group, phase III superiority trial, including a total of 452 patients with cirrhosis and esophageal varices that are at high risk of bleeding.
Potential impact of the study: In view of the encouraging results obtained with carvedilol in prior studies, we believe a trial comparing propranolol to carvedilol in terms of clinical outcomes is necessary to clearly establish whether carvedilol should become the treatment of choice for the primary prohylaxis of variceal bleeding. If this trial is successfully conducted, results can be expected to have a substantial impact on clinical practice and future research directions.