Rivaroxaban May Improve Outcomes in Cirrhosis

TOPLINE:

Rivaroxaban improved portal hypertension-related complication-free survival in patients with cirrhosis and moderate liver dysfunction, without significantly increasing the risk for major bleeding events.

METHODOLOGY:

• Researchers conducted a randomised trial of 90 patients with cirrhosis, portal hypertension, and moderate liver dysfunction (on the basis of the Child-Pugh score) who were enrolled at 14 hospitals in Spain between May 2016 and October 2020 to assess the improvement in outcomes with rivaroxaban.
• Patients were randomly assigned to receive either 10 mg rivaroxaban daily (n = 41; median age, 58 years; 85.4% men) or matched placebo (n = 49; median age, 59 years; 79.6% men) for up to 24 months.
• The primary combined endpoint was the time to the first occurrence of any portal hypertension-related complication (including new-onset ascites, portal hypertensive gastrointestinal bleeding, and overt hepatic encephalopathy), death, portal vein thrombosis, hepatocellular carcinoma, or liver transplantation.
• The safety of rivaroxaban and the incidence of non-portal hypertension-related bleeding events were also assessed. The mean follow-up duration was 10.1 months.

TAKEAWAY:

• The primary combined endpoint occurred in 26.8% of patients in the rivaroxaban group vs 46.9% of those in the placebo group, with 1-year survival probabilities of 78.7% vs 54.4% and 2-year survival probabilities of 67.1% vs 43.0%.
• The risk of reaching the main endpoint was reduced in the rivaroxaban group (adjusted hazard ratio [HR], 0.418; 95% CI, 0.204-0.858).
• In a subgroup analysis, a significant effect of rivaroxaban vs placebo was observed in patients with a Child-Pugh B score of 7 points (n = 55; HR, 0.258; 95% CI, 0.074-0.900).
• The rivaroxaban group experienced bleeding events related to non-portal hypertension more frequently than the placebo group (relative risk, 2.56; 95% CI, 1.16-5.67); no differences in first or recurrent portal hypertension-related bleeding or other adverse events were observed between the two groups.

IN PRACTICE:

“Unfortunately, there was no clinical or biochemical parameter able to predict rivaroxaban levels obtained after 10 mg rivaroxaban and, if our data on the beneficial effects of rivaroxaban are confirmed, monitoring of rivaroxaban plasma levels would be required to reduce bleeding risk,” the authors of the study wrote.

SOURCE:

This study was led by Ángela Puente, PhD, Valdecilla Research Institute (IDIVAL), Marqués de Valdecilla University Hospital, Santander, Spain. It was published online on July 19, 2025, in the Journal of Hepatology.

LIMITATIONS:

The trial was underpowered to show statistical significance. The direct effect of rivaroxaban on portal pressure was not assessed. Alcohol consumption was tracked during follow-up visits through direct questioning, without using scales or biochemical markers.

DISCLOSURES:

This study was supported by grants from Instituto de Salud Carlos III and co-funded by the European Union. Support was also received from “Commissioner for Universities and Research from the Department of Economy and Knowledge” of the “Generalitat de Catalunya.” Some authors reported receiving grants from Instituto de Salud Carlos III. The authors declared having no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.