Rivaroxaban versus low-molecular weight heparin plus warfarin prevents portal vein system thrombosis after splenectomy and pericardial devascularization: A randomized clinical trial / 西安交通大学学报(医学版)

ABSTRACT

【Objective】 To evaluate the safety and efficacy of rivaroxaban in preventing portal vein system thrombosis （PVST） in patients with liver cirrhosis after splenectomy and pericardial devascularization. 【Methods】 Totally 76 cirrhotic patients underwent splenectomy and pericardial devascularization were randomly assigned to rivaroxaban treatment group （n=38） or low-molecular weight heparin （LMWH） plus warfarin treatment group （n=38）. The experimental group was given rivaroxaban 10 mg orally， once a day， for 30 days. The control group was given subcutaneous injection of 5000 IU low molecular weight heparin （LMWH） twice a day for 5 days and warfarin （initial dose 2.5 mg） orally once a day for 30 days. Both groups were followed up for 1 year. We compared the two groups in the incidence of PVST， recovery of liver function and coagulation function， decompensation of liver function， incidence of liver cancer， and active bleeding. 【Results】 Totally 18 patients （47.4%） in rivaroxaban group developed PVST， compared with 29 patients （76.3%） in LMWH plus warfarin group （P=0.024）. The incidence of PVST during the first year after operation was significantly lower in rivaroxaban group than in LMWH plus warfarin group （F=7.852， P=0.007）. The intra-group comparisons versus baseline showed that the liver function improved from POD 21 to POM 1， and coagulation function improved from POM 2 in rivaroxaban group. In contrast， the liver function improved from POM 1 to POM 2， and coagulation function improved from POM 4 in LMWH plus warfarin group. The two groups did not significantly differ in liver function decompensation， incidence of liver cancer， or active bleeding （all P>0.05）. 【Conclusion】 The prophylactic use of rivaroxaban significantly decreases the incidence of PVST after splenectomy and pericardial devascularization in cirrhotic patients compared to LMWH plus warfarin treatment. Besides， rivaroxaban treatment is safe and effective and is associated with improved liver and coagulation functions than LMWH plus warfarin treatment.