Xarelto boosts survival for portal hypertension in cirrhosis without hike in bleeding risk
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Xarelto improved portal hypertension complication-free survival in patients with cirrhosis and moderate liver dysfunction without an increase in major bleeding events, according to data presented at the EASL Congress.
“Observational studies and a non-double-blind, non-placebo randomized study suggested that anticoagulation decreases the probability of developing portal hypertension complications and improves survival in patients with cirrhosis,” Angela Puente Sanchez, MD, a clinical practitioner at the Marqués de Valdecilla University Hospital in Spain, said during the presentation. “A recent individual patient data meta-analysis in patients with cirrhosis and [portal venous thrombosis] suggests that anticoagulation improves survival independently of achieving recanalization of thrombosis.”
She continued: “Our study’s hypothesis is rivaroxaban [Xarelto, Janssen/Bayer], an anticoagulant drug that inhibits thrombin generation by blocking Xa activity and could prevent [hepatic stellate cell] activation, may be a safe and effective drug in preventing complications of cirrhosis.”
In a multicenter, randomized, double-blind clinical trial, Sanchez and colleagues assigned 90 patients (median age, 58.1 years; 82.2% men) with cirrhosis, portal hypertension and moderate liver disfunction (Child-Pugh score, 7 to 10) to rivaroxaban 10 mg per day (n = 41) or placebo (n = 49) for 24 months.
The primary composite endpoint was patient survival without liver transplantation or development of complications from portal hypertension. Secondary endpoints included the effect of rivaroxaban on transplant-free survival, individual complications from portal hypertension, development of portal vein thrombosis and safety with regard to bleeding complications and hepatotoxicity.
Of 90 patients included in the intention-to-treat analysis, 34 achieved the primary endpoint, 23 in the placebo group and 11 in the rivaroxaban group.
The cumulative probability of the primary endpoint in patients given placebo at 1 and 2 years was 40.1% and 60.9%, respectively, and 21.6% and 33.2% in those treated with rivaroxaban. After adjusting for Child-Pugh score, researchers reported this difference was statistically significant (HR = 0.466; 95% CI, 0.222–0.98).
Of 78 patients included in per-protocol analysis, 41 patients were treated with placebo and 37 were treated with rivaroxaban. The researchers determined that 69% of patients treated with rivaroxaban achieved the primary endpoint vs. 41% treated with placebo (P =.051)
Sanchez and colleagues also assessed 66 patients with Child-Pugh B7 in a separate sub-analysis and reported nearly 80% of patients treated with rivaroxaban were free of liver decompensation at 24 months compared with 47% of those treated with placebo.
In total, 31 non-portal hypertension bleeding events were noted in 24 patients; however, there was no difference in major bleeding events between treatment arms, with researchers reporting two in the placebo group and six in the rivaroxaban group. There was one death in the placebo group due to major bleeding.
“Our study supports that in patients with cirrhosis and moderate hepatic impairment, treatment with rivaroxaban would improve [portal hypertension] complication-free survival without significantly increasing bleeding effects,” Sanchez said.
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Sanchez AP, et al. Abstract GS- 003: Rivaroxaban improves survival and decompensation in cirrhotic patients with moderate liver dysfunction: Double-blind, placebo-controlled trial. Presented at: EASL Congress; June 21-24, 2023; Vienna (hybrid meeting).
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