title: Enoxaparin prevents portal vein thrombosis and liver decompensation in patients with advanced cirrhosis.
abstract: OBJECTIVE
  We performed a randomized controlled trial to evaluate the safety and efficacy of enoxaparin, a low-molecular-weight heparin, in preventing portal vein thrombosis (PVT) in patients with advanced cirrhosis.
  
  
  METHODS
  In a nonblinded, single-center study, 70 outpatients with cirrhosis (Child-Pugh classes B7-C10) with demonstrated patent portal veins and without hepatocellular carcinoma were assigned randomly to groups that were given enoxaparin (4000 IU/day, subcutaneously for 48 weeks; n = 34) or no treatment (controls, n = 36). Ultrasonography (every 3 months) and computed tomography (every 6 months) were performed to check the portal vein axis. The primary outcome was prevention of PVT. Radiologists and hepatologists that assessed outcomes were blinded to group assignments. Analysis was by intention to treat.
  
  
  RESULTS
  At 48 weeks, none of the patients in the enoxaparin group had developed PVT, compared with 6 of 36 (16.6%) controls (P = .025). At 96 weeks, no patient developed PVT in the enoxaparin group, compared with 10 of 36 (27.7%) controls (P = .001). At the end of the follow-up period, 8.8% of patients in the enoxaparin group and 27.7% of controls developed PVT (P = .048). The actuarial probability of PVT was lower in the enoxaparin group (P = .006). Liver decompensation was less frequent among patients given enoxaparin (11.7%) than controls (59.4%) (P < .0001); overall values were 38.2% vs 83.0%, respectively (P < .0001). The actuarial probability of liver decompensation was lower in the enoxaparin group (P < .0001). Eight patients in the enoxaparin group and 13 controls died. The actuarial probability of survival was higher in the enoxaparin group (P = .020). No relevant side effects or hemorrhagic events were reported.
  
  
  CONCLUSIONS
  In a small randomized controlled trial, a 12-month course of enoxaparin was safe and effective in preventing PVT in patients with cirrhosis and a Child-Pugh score of 7-10. Enoxaparin appeared to delay the occurrence of hepatic decompensation and to improve survival.
authors: Department of Gastroenterology, Azienda Ospedaliero-Universitaria and University of Modena and Reggio Emilia, Modena, Italy. Electronic address: erica.villa@unimore.it.
authors: Erica
authors: E
authors: Villa
authors: Sezione di Gastroenterologia, Dipartimento Biomedico di Medicina Interna e Specialistica, University of Palermo, Palermo, Italy.
authors: Calogero
authors: C
authors: Cammà
authors: Department of Haematology, Azienda Ospedaliero-Universitaria, Modena, Italy.
authors: Marco
authors: M
authors: Marietta
authors: Department of Gastroenterology, Azienda Ospedaliero-Universitaria and University of Modena and Reggio Emilia, Modena, Italy.
authors: Monica
authors: M
authors: Luongo
authors: Department of Gastroenterology, Azienda Ospedaliero-Universitaria and University of Modena and Reggio Emilia, Modena, Italy.
authors: Rosina
authors: R
authors: Critelli
authors: Department of Radiology, Azienda Ospedaliero-Universitaria, Modena, Italy.
authors: Stefano
authors: S
authors: Colopi
authors: Department of Radiology, Azienda Ospedaliero-Universitaria, Modena, Italy.
authors: Cristina
authors: C
authors: Tata
authors: Department of Gastroenterology, Azienda Ospedaliero-Universitaria and University of Modena and Reggio Emilia, Modena, Italy.
authors: Ramona
authors: R
authors: Zecchini
authors: Department of Gastroenterology, Azienda Ospedaliero-Universitaria and University of Modena and Reggio Emilia, Modena, Italy.
authors: Stefano
authors: S
authors: Gitto
authors: Sezione di Gastroenterologia, Dipartimento Biomedico di Medicina Interna e Specialistica, University of Palermo, Palermo, Italy.
authors: Salvatore
authors: S
authors: Petta
authors: Department of Gastroenterology, Azienda Ospedaliero-Universitaria and University of Modena and Reggio Emilia, Modena, Italy.
authors: Barbara
authors: B
authors: Lei
authors: Department of Gastroenterology, Azienda Ospedaliero-Universitaria and University of Modena and Reggio Emilia, Modena, Italy.
authors: Veronica
authors: V
authors: Bernabucci
authors: Department of Gastroenterology, Azienda Ospedaliero-Universitaria and University of Modena and Reggio Emilia, Modena, Italy.
authors: Ranka
authors: R
authors: Vukotic
authors: Department of Gastroenterology, Azienda Ospedaliero-Universitaria and University of Modena and Reggio Emilia, Modena, Italy.
authors: Nicola
authors: N
authors: De Maria
authors: Department of Gastroenterology, Azienda Ospedaliero-Universitaria and University of Modena and Reggio Emilia, Modena, Italy.
authors: Filippo
authors: F
authors: Schepis
authors: Department of Gastroenterology, Azienda Ospedaliero-Universitaria and University of Modena and Reggio Emilia, Modena, Italy.
authors: Aimilia
authors: A
authors: Karampatou
authors: Department of Radiology, Azienda Ospedaliero-Universitaria, Modena, Italy.
authors: Cristian
authors: C
authors: Caporali
authors: Haematology Laboratory, Azienda Ospedaliero-Universitaria, Modena, Italy.
authors: Luisa
authors: L
authors: Simoni
authors: Department of Gastroenterology, Azienda Ospedaliero-Universitaria and University of Modena and Reggio Emilia, Modena, Italy.
authors: Mariagrazia
authors: M
authors: Del Buono
authors: Department of Gastroenterology, Azienda Ospedaliero-Universitaria and University of Modena and Reggio Emilia, Modena, Italy.
authors: Beatrice
authors: B
authors: Zambotto
authors: Department of Gastroenterology, Azienda Ospedaliero-Universitaria and University of Modena and Reggio Emilia, Modena, Italy.
authors: Elena
authors: E
authors: Turola
authors: Azienda Santa Maria Nuova, Reggio Emilia, Italy.
authors: Giovanni
authors: G
authors: Fornaciari
authors: Azienda Santa Maria Nuova, Reggio Emilia, Italy.
authors: Susanna
authors: S
authors: Schianchi
authors: Department of Gastroenterology, Azienda Ospedaliero-Universitaria and University of Modena and Reggio Emilia, Modena, Italy.
authors: Anna
authors: A
authors: Ferrari
authors: Service d'Hépatologie, Hôpital Beaujon, APHP, Clichy, France; Université Paris-Diderot, Paris, France; INSERM U773-CRB3, Paris, France.
authors: Dominique
authors: D
authors: Valla
mesh_terms: D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000097:blood; D018988:Bacterial Translocation; D015415:Biomarkers / Q000097:blood; D004269:DNA, Bacterial / Q000097:blood*; D017984:Enoxaparin / Q000009:adverse effects / Q000627:therapeutic use*; D050556:Fatty Acid-Binding Proteins / Q000097:blood; D005260:Female; D006801:Humans; D015850:Interleukin-6 / Q000097:blood; D053208:Kaplan-Meier Estimate; D018950:Lipopolysaccharide Receptors / Q000097:blood; D008103:Liver Cirrhosis / Q000150:complications*; D017093:Liver Failure / Q000209:etiology / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D012082:Renal Veins; D018709:Statistics, Nonparametric; D013927:Thrombosis / Q000150:complications / Q000517:prevention & control*
chemical_list: D000925:Anticoagulants; D015415:Biomarkers; D004269:DNA, Bacterial; D017984:Enoxaparin; D050556:Fatty Acid-Binding Proteins; D015850:Interleukin-6; D018950:Lipopolysaccharide Receptors