Efficacy and safety of edoxaban following danaparoid sodium administration for treatment of portal vein thrombosis in patients with cirrhosis

Abstract

Aim: To evaluate the efficacy and safety of edoxaban in comparison with warfarin for treatment of portal vein thrombosis (PVT) following danaparoid sodium administration in patients with cirrhosis.

Methods: 64 cirrhotic patients with PVT treated initially for 2 weeks by danaparoid sodium were enrolled retrospectively. In all patients, either edoxaban (n = 34) or warfarin (n = 30) were administrated then later. The efficacy and safety of edoxaban were compared to those of warfarin for up to 6 months. PVT volume was measured by dynamic CT at baseline and at 2 weeks, 1, 3 and 6 months.

Results: Significant differences in clinical characteristics of patients were not found between both groups. Edoxaban intakes reduced volume of PVT from 1.72 cm³ at 2 weeks to 0.44 cm³ at 6 months, and prevented exacerbation of PVT at 6 months after treatment with danaparoid sodium (p = 0.008). Warfarin intakes, however, resulted in increase of PVT volume from 1.37 cm³ at 2 weeks to 2.65 cm³ at 6 months, despite that prothrombin time international normalized ratio (INR) of 1.5 or more was maintained in 57% of patients (p = 0.005). Multivariate regression analysis identified edoxaban therapy as a single significant and independent determinant contributing PVT reduction at 6 months (p<0.001). Gastrointestinal bleeding occurred in 4 of 34 (12%) patients in the edoxaban group, while 2 of 30 (7%) in the warfarin group (p = 0.485).

Conclusion: Edoxaban intakes following danaparoid sodium administration were effective and merit consideration as one of therapeutic options for PVT in cirrhotic patients.