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

ABSTRACT: 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.

SUBMITTER: Yao W

PROVIDER: S-EPMC8056059 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:The gut microbiome is an essential component of the intestinal mucosal barrier, critical in regulating intestinal permeability. Microbiome dysbiosis and intestinal permeability changes are commonly encountered conditions in patients with cirrhosis and are closely related to its development and further complications. However, alterations in the gut microbiome and intestinal permeability in chronic hepatitis B virus (HBV) patients with cirrhotic portal hypertension after undergoing a splenectomy plus pericardial devascularization (SPD) have not been investigated. This study recruited 22 patients who were measured against themselves on the study parameters before and after an SPD, along with 20 healthy controls. Methodologically, fecal samples were collected for gut microbiome analysis by 16S ribosomal DNA sequencing, and peripheral blood samples were obtained to examine the liver function and intestinal permeability. This study showed that the community structure of the gut microbiomes in patients before the SPD exhibited obvious differences from those in the healthy control group. They also exhibited a decreased bacterial community richness, increased intestinal permeability, and enhanced inflammation compared with the healthy controls. These issues were further aggravated two weeks after the SPD. There was also evidence of significantly higher abundances of Streptococcaceae, Enterobacteriaceae, and Enterococcaceae than those in the healthy control group. However, 12 months after the surgery, 12 of the 16 patient-associated genera recovered, of which 10 reached normal levels. Additionally, the microbiome diversity increased; the bacterial composition was back to a level similar to the healthy controls. Liver function, intestinal permeability, and inflammation levels all improved compared with preoperative levels. Furthermore, correlation analyses indicated that the five recovered bacterial taxa and the Shannon diversity index were correlated with several improved clinical indicators. Altogether, the improvements in the liver function and intestinal permeability in HBV-related cirrhotic patients may be related to the restoration of the gut microbiome after an SPD.

Project description:ObjectiveSplenectomy is one crucial solution for hypersplenism with portal hypertension. However, portal vein system thrombosis (PVST) caused by hemodynamic changes affects the prognosis of patients. We analyze the changes in portal vein hemodynamics following splenectomy for Wilson's disease combined with portal hypertension and the influencing factors that lead to PVST.MethodsA retrospective cohort study was conducted, in which 237 Wilson's disease patients with hypersplenism underwent splenectomy. The hemodynamic indices of the portal vein were monitored before surgery and on the 1st, 7th, and 14th days around surgery. The patients were divided into PVST and non-PVST groups. The clinical factors were identified by univariate and multivariate logistic regression. The Logit P was calculated according to the logistic regression prediction model, and the ROC curve for each independent factor was plotted.ResultsThe portal vein velocity, flow, and inner diameter showed a downward trend around surgery, with statistically significant differences between each time point (P < 0.01). The PVST incidence rate was 55.7%. Univariate analysis revealed that the platelet (PLT) levels on the postoperative 3rd and 7th days (P = 0.001; P < 0.001), D-dimer (D-D) on the postoperative 7th and 14th days (P = 0.002; P < 0.001), preoperative portal vein velocity, flow, diameter (P < 0.001), and splenic vein diameter (P < 0.001) were all statistically and significantly different between the two groups. Multivariate logistic regression revealed a significant increase in PLT on the postoperative 7th day (OR = 1.043, 95% CI, 1.027-1.060, P < 0.001) and D-D on the postoperative 14th day (OR = 1.846, 95% CI, 1.400-2.435, P < 0.001). Preoperative portal and splenic vein diameters (OR = 1.565, 95% CI, 1.213-2.019, P = 0.001; OR = 1.671, 95% CI, 1.305-2.140, P < 0.001) were the risk factors for PVST. However, preoperative portal vein velocity and flow (OR = 0.578, 95% CI, 0.409-0.818, P = 0.002; OR = 0.987, 95% CI, 0.975-0.990, P = 0.046) were protective factors for PVST. Logit P was calculated using a logistic regression prediction model with a cut-off value of -0.32 and an area under receiver operating characteristic curve of 0.952 with 88.61% accuracy.ConclusionsSplenectomy relieves portal hypertension by reducing the hemodynamics index. PVST is linked to multiple factors, including preoperative portal vein diameter, velocity, flow, and splenic vein diameter, especially PLT on the postoperative 7th day and D-D on the postoperative 14th day. The predictive model is accurate in predicting PVST.

Project description:ObjectiveSplenectomy is a vital treatment method for hypersplenism with portal hypertension. However, portal venous system thrombosis (PVST) is a serious problem after splenectomy. Therefore, constructing an effective visual risk prediction model is important for preventing, diagnosing, and treating early PVST in hepatolenticular degeneration (HLD) surgical patients.MethodsBetween January 2016 and December 2021, 309 HLD patients were selected. The data were split into a development set (215 cases from January 2016 to December 2019) and a validation set (94 cases from January 2019 to December 2021). Patients' clinical characteristics and laboratory examinations were obtained from electronic medical record system, and PVST was diagnosed using Doppler ultrasound. Univariate and multivariate logistic regression analyses were used to establish the prediction model by variables filtered by LASSO regression, and a nomogram was drawn. The area under the curve (AUC) of receiver operating characteristic (ROC) curve and Hosmer-Lemeshow goodness-of-fit test were used to evaluate the differentiation and calibration of the model. Clinical net benefit was evaluated by using decision curve analysis (DCA). The 36-month survival of PVST was studied as well.ResultsSeven predictive variables were screened out using LASSO regression analysis, including grade, POD14D-dimer (Postoperative day 14 D-dimer), POD7PLT (Postoperative day 7 platelet), PVD (portal vein diameter), PVV (portal vein velocity), PVF (portal vein flow), and SVD (splenic vein diameter). Multivariate logistic regression analysis revealed that all seven predictive variables had predictive values (P < 0.05). According to the prediction variables, the diagnosis model and predictive nomogram of PVST cases were constructed. The AUC under the ROC curve obtained from the prediction model was 0.812 (95% CI: 0.756-0.869) in the development set and 0.839 (95% CI: 0.756-0.921) in the validation set. Hosmer-Lemeshow goodness-of-fit test fitted well (P = 0.858 for development set; P = 0.137 for validation set). The nomogram model was found to be clinically useful by DCA. The 36-month survival rate of three sites of PVST was significantly different from that of one (P = 0.047) and two sites (P = 0.023).ConclusionThe proposed nomogram-based prediction model can predict postoperative PVST. Meanwhile, an earlier intervention should be performed on three sites of PVST.

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

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