Rivaroxaban versus low-molecular weight heparin plus warfarin prevents portal vein system thrombosis after splenectomy and pericardial devascularization: A randomized clinical trial.

This study aimed 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. 70 cirrhotic patients undergoing splenectomy and pericardial devascularization were randomly assigned to rivaroxaban treatment (n=35) or low-molecular weight heparin (LMWH) plus warfarin treatment (n=35) for 30 days in this randomized controlled trial. The primary endpoint is the PVST formation. Ultrasound doctors and radiologists were blinded to the randomization results. Both groups received routine outpatient inspection every month and were followed for one year. 17 patients (48.6 %) in rivaroxaban group developed PVST, compared with 27 patients (77.1 %) in LMWH plus warfarin group (P=0.025). The incidence of PVST during the first year postoperation was significantly lower in rivaroxaban group than in LMWH plus warfarin group (F=7.901, P=0.006). The intra-group comparisons versus baseline showed 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 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 was safe and effective and associated with better liver and coagulation functions improvement than LMWH plus warfarin treatment.