Rivaroxaban may prevent PHT-related complications in cirrhosis

Treatment with rivaroxaban appears to improve portal hypertension (PHT)-related complications without increasing the risk of major bleeding in patients with cirrhosis and moderate liver dysfunction, a study has shown.

Ninety patients were randomized to receive either rivaroxaban 10 mg daily (n=41) or placebo (n=49) for 24 months. The primary composite endpoint was the development of a PHT-related complication or death/liver transplantation, whichever occurred first. The investigators performed analyses using both modified intention-to-treat and per-protocol approaches.

Of these, 34 (11 in the rivaroxaban arm vs 23 in the placebo arm) developed a PHT-related complication, had liver transplantation, or died over a median follow-up of 10.1 months.

The cumulative probability of survival free from the primary endpoint was 54.4 percent at 1 year and 43.0 percent at 2 years in the placebo group compared with 78.7 percent and 67.1 percent, respectively, in the rivaroxaban group (log-rank p=0.058).

A post hoc analysis of patients with Child-Pugh B7 scores (n=55) revealed a potentially beneficial effect with rivaroxaban (hazard ratio [HR], 0.258, 95 percent confidence interval [CI], 0.074‒0.900).

The per-protocol analysis (37 rivaroxaban, 41 placebo) revealed the occurrence of the primary event in 19 patients in the placebo group and nine in the rivaroxaban group (46.3 percent vs 24.3 percent; HR, 0.463, 95 percent CI, 0.209‒1.024).

The rivaroxaban group had significantly higher non‒PHT-related bleeding events than the placebo group (36.6 percent vs 14.3 percent; relative risk, 2.56, 95 percent CI, 1.16‒5.67), but no significant between-group differences were noted in major bleeding events.