Efficacy and Safety of Carvedilol in Cirrhosis Patients With New-Onset Uncomplicated Ascites Without High-Risk Esophageal Varices (CARVE-AS Trial)

作者：Rahul Khajuria, Ankur Jindal, Manoj Kumar, Vinod Arora, Ashish Kumar Vyas, Guresh Kumar, Shiv Kumar Sarin · 发表于：The American Journal of Gastroenterology · 年份：2025 · DOI：10.14309/ajg.0000000000003650 · 被引用次数：5 · 研究领域：Liver Disease and Transplantation、Venous Thromboembolism Diagnosis and Management、Liver Disease Diagnosis and Treatment

INTRODUCTION: Carvedilol is effective in the prevention of bleeding in patients with cirrhosis and high-risk varices. Although it reduces drivers of clinical decompensation (portal pressure, systemic inflammation, and bacterial translocation), the data on its use for prevention of ascites-related complications are limited. METHODS: In this open-label randomized control tria, patients having uncomplicated new-onset ascites with no or low-risk esophageal varices were randomized (n = 104) to receive carvedilol (group A, n = 52) or no carvedilol (group B, n = 52) in addition to standard treatment. The composite primary outcome was incidence of any ascites-related complications, namely, spontaneous bacterial peritonitis, hepatorenal syndrome acute kidney injury, refractory ascites, or severe hyponatremia at 1 year. The secondary outcomes included need for paracentesis, change in hepatic venous pressure gradient, Child-Turcotte-Pugh, and Model for End-Stage Liver Disease score and mortality at 1 year. RESULTS: The baseline characteristics were comparable between the groups, with metabolic dysfunction-associated steatotic liver disease as the commonest etiology (overall 41.3%) followed by alcohol-associated liver disease (21.2%). Patients in group A compared with group B had lower incidence of complicated ascites (38.5% vs 67.3%; P = 0.03), mainly related to reduced incidence of acute kidney injury (AKI) (34.6% vs 63.4%, P = 0.003), refractory ascites, and spontaneous bacterial peri...