Original ResearchClinical—LiverEnoxaparin Prevents Portal Vein Thrombosis and Liver Decompensation in Patients With Advanced Cirrhosis
Section snippets
Study Design and Participants
Between April 2008 and November 2010, all consecutive patients seen at a tertiary referral liver unit (Azienda Ospedaliero-Universitaria, Modena) and satisfying predefined inclusion criteria were recruited. Eligible patients were 18 years and older and had cirrhosis of any etiology, a Child–Pugh score between B7 and C10, absence of ascites, spontaneous bacterial peritonitis (SBP), portal hypertensive bleeding or portosystemic encephalopathy for at least 3 months before enrollment, and no
Results
Supplementary Figure 1 shows the trial profile. A total of 396 patients with cirrhosis were screened for study eligibility: 326 patients were excluded (Supplementary Figure 1), and 70 patients were assigned randomly to the enoxaparin (n = 34) or control group (n = 36). All patients but 1 (withdrawn for thrombocytopenia) completed the treatment. The trial was completed as planned in November 2011. There were no missing values for the primary outcome. There were no significant differences in
Discussion
The results of this RCT in a cohort of patients with advanced cirrhosis showed that anticoagulant treatment with enoxaparin is safe and effective, significantly reducing risk of PVT development and liver decompensation, markedly improving liver function and Child–Pugh score, and increasing overall survival. Our findings are consistent with data showing that successful PVT recanalization is accompanied by improvement of the Child–Pugh score.23
It is plausible that PVT prevention has a protective
Acknowledgments
E.V., M.L., R.C., B.L., V.B., R.V., A.K., M.D.B., E.T., and A.F. on behalf of the Research Network “Women_in_Hepatology.”
The corresponding author had full access to all of the data and takes full responsibility for the veracity of the data and statistical analysis.
References (33)
- et al.
Risk factors and clinical presentation of portal vein thrombosis in patients with liver cirrhosis
J Hepatol
(2004) - et al.
Portal vein thrombosis: a predictable milestone in cirrhosis?
J Hepatol
(2009) - et al.
Portal hypertension: diagnosis and treatment
J Hepatol
(1995) Portal vein thrombosis, revisited
Dig Liver Dis
(2010)- et al.
Thrombotic risk factors in patients with liver cirrhosis: correlation with MELD scoring system and portal vein thrombosis development
J Hepatol
(2009) - et al.
Current outcome of portal vein thrombosis in adultsRisk and benefit of anticoagulant therapy
Gastroenterology
(2001) - et al.
Increased intestinal permeability to macromolecules and endotoxemia in patients with chronic alcohol abuse in different stages of alcohol-induced liver disease
J Hepatol
(2000) - et al.
Alterations in colonic mucosal vessels in patients with cirrhosis and noncirrhotic portal hypertension
Hum Pathol
(1998) Bacterial translocation from the gastrointestinal tract
Trends Microbiol
(1995)- et al.
Patients with acute or chronic liver failure display ‘sepsis-like' immune paralysis
J Hepatol
(2005)
Low molecular weight heparin downregulates tissue factor expression and activity by modulating growth factor receptor-mediated induction of nuclear factor-κB
Biochim Biophys Acta
An accompanying genetic severe deficiency of tissue factor protects mice with a protein C deficiency from lethal endotoxemia
Blood
Rebalanced hemostasis in patients with liver disease: evidence and clinical consequences
Blood
Thrombosis and intimal thickening in the portal system in cirrhosis of the liver
J Pathol Bacteriol
Systematic review: portal vein thrombosis in cirrhosis
Aliment Pharmacol Ther
Portal vein thrombosis in liver cirrhosis
Intern Emerg Med
Cited by (581)
Gut-liver axis: Pathophysiological concepts and medical perspective in chronic liver diseases
2024, Seminars in ImmunologyEvolving portal hypertension through Baveno VII recommendations
2024, Annals of HepatologyManaging a Prospective Liver Transplant Recipient on the Waiting List
2024, Journal of Clinical and Experimental HepatologyA major research gap: The use of anticoagulants in cirrhosis
2023, Journal of HepatologyThe prothrombotic tendency of metabolic-associated fatty liver disease
2023, Journal of Thrombosis and Haemostasis
This article has an accompanying continuing medical education activity on page e17. Learning Objective: Upon completion of this exam, successful learners will be able to correctly identify patients with cirrhosis who should be considered for prophylactic anticoagulation, to formulate a correct surveillance protocol, to select the appropriate treatment schedule, and to prevent PVT.
Conflicts of interest The authors disclose no conflicts.
Funding This study was independently designed and was not supported by any pharmaceutical company. The National Health System provided enoxaparin. This study adheres to the standards of accountability, access to data, and control of publications of the International Committee of Medical Journal Editors.33 The study protocol was approved by the Ethics Committee of Azienda Ospedaliero-Universitaria, Modena (ISRCTN32383354, EudraCT 2007-007890-22).