Dou-Sheng Bai1, Bing-Lan Xia2, Chi Zhang1, Jing Ye3, Jian-Jun Qian1, Sheng-Jie Jin1, Guo-Qing Jiang4. 1. Departments of Hepatobiliary Surgery, Clinical Medical College, Yangzhou University, 98 West Nantong Rd, Yangzhou, Jiangsu, 225000, China. 2. Departments of Ultrasound, Clinical Medical College, Yangzhou University, 98 West Nantong Rd, Yangzhou, Jiangsu, 225000, China. 3. Department of Medical Imaging, Clinical Medical College, Yangzhou University, 98 West Nantong Rd, Yangzhou, Jiangsu, 225000, China. 4. Departments of Hepatobiliary Surgery, Clinical Medical College, Yangzhou University, 98 West Nantong Rd, Yangzhou, Jiangsu, 225000, China. Electronic address: jgqing2003@hotmail.com.
Abstract
INTRODUCTION:Portal vein system thrombosis (PVST) is a common, potentially life-threatening complication after splenectomy. The optimal recognized anticoagulation drugs for preventing PVST in cirrhotic patients after splenectomy remain unclear. The aim of this study is to evaluate the safety and efficacy of warfarin in preventing PVST after laparoscopic splenectomy and azygoportal disconnection (LSD). METHODS: In this randomized controlled single-center study, 80 cirrhotic patients who underwent LSD were randomly assigned to 2 years of treatment with either warfarin (n = 40) or aspirin (n = 40). The primary outcome was prevention of PVST. Sonographers and radiologists who assessed outcomes were blinded to group assignments. Intention-to-treat analysis was performed. RESULTS: During the first year, excluding two patients withdrawing from the study, 15 of the 39 warfarin-treated patients (38.5%) and five of the 39 aspirin-treated patients (12.8%) did not develop PVST (P = 0.010). The incidence of PVST in the first 2 postoperative years was significantly lower in the warfarin group than in the aspirin group (F = 7.360, P = 0.008). The warfarin group in paired within-group comparisons had significantly greater improvements in total bilirubin and albumin levels at baseline versus at 6 months postoperatively and in creatinine levels at baseline versus at 12, 18, and 24 months postoperatively respectively (all P < 0.05). In contrast, those paired comparisons of the aspirin group showed no significant differences (all P > 0.05). CONCLUSIONS:Warfarin therapy was safe and effective and significantly reduced the risk of PVST after LSD, compared with aspirin treatment. Warfarin treatment was associated with better liver function protection and renal function improvement than aspirin treatment.
RCT Entities:
INTRODUCTION: Portal vein system thrombosis (PVST) is a common, potentially life-threatening complication after splenectomy. The optimal recognized anticoagulation drugs for preventing PVST in cirrhotic patients after splenectomy remain unclear. The aim of this study is to evaluate the safety and efficacy of warfarin in preventing PVST after laparoscopic splenectomy and azygoportal disconnection (LSD). METHODS: In this randomized controlled single-center study, 80 cirrhotic patients who underwent LSD were randomly assigned to 2 years of treatment with either warfarin (n = 40) or aspirin (n = 40). The primary outcome was prevention of PVST. Sonographers and radiologists who assessed outcomes were blinded to group assignments. Intention-to-treat analysis was performed. RESULTS: During the first year, excluding two patients withdrawing from the study, 15 of the 39 warfarin-treated patients (38.5%) and five of the 39 aspirin-treated patients (12.8%) did not develop PVST (P = 0.010). The incidence of PVST in the first 2 postoperative years was significantly lower in the warfarin group than in the aspirin group (F = 7.360, P = 0.008). The warfarin group in paired within-group comparisons had significantly greater improvements in total bilirubin and albumin levels at baseline versus at 6 months postoperatively and in creatinine levels at baseline versus at 12, 18, and 24 months postoperatively respectively (all P < 0.05). In contrast, those paired comparisons of the aspirin group showed no significant differences (all P > 0.05). CONCLUSIONS:Warfarin therapy was safe and effective and significantly reduced the risk of PVST after LSD, compared with aspirin treatment. Warfarin treatment was associated with better liver function protection and renal function improvement than aspirin treatment.