title: A randomized trial to assess whether portal pressure guided therapy to prevent variceal rebleeding improves survival in cirrhosis.
abstract: Monitoring the hemodynamic response of portal pressure (PP) to drug therapy accurately stratifies the risk of variceal rebleeding (VRB). We assessed whether guiding therapy with hepatic venous pressure gradient (HVPG) monitoring may improve survival by preventing VRB. Patients with cirrhosis with controlled variceal bleeding were randomized to an HVPG-guided therapy group (N = 84) or to a control group (N = 86). In both groups, HVPG and acute β-blocker response were evaluated at baseline and HVPG measurements were repeated at 2-4 weeks to determine chronic response. In the HVPG-guided group, acute responders were treated with nadolol and acute nonresponders with nadolol+nitrates. Chronic nonresponders received nadolol+prazosin and had a third HVPG study. Ligation sessions were repeated until response was achieved. The control group was treated with nadolol+nitrates+ligation. Between-group baseline characteristics were similar. During long-term follow-up (median of 24 months), mortality was lower in the HVPG-guided therapy group than in the control group (29% vs. 43%; hazard ratio [HR] = 0.59; 95% confidence interval [CI] = 0.35-0.99). Rebleeding occurred in 19% versus 31% of patients, respectively (HR = 0.53; 95% CI = 0.29-0.98), and further decompensation of cirrhosis occurred in 52% versus 72% (HR = 0.68; 95% CI = 0.46-0.99). The survival probability was higher with HVPG-guided therapy than in controls, both in acute (HR = 0.59; 95% CI = 0.32-1.08) and chronic nonresponders (HR = 0.48; 95% CI = 0.23-0.99). HVPG-guided patients had a greater reduction of HVPG and a lower final value than controls (P < 0.05).
  
  
  CONCLUSIONS
  HVPG monitoring, by stratifying risk and targeting therapy, improves the survival achieved with currently recommended treatment to prevent VRB using β-blockers and ligation. HVPG-guided therapy achieved a greater reduction in PP, which may have contributed to reduce the risk of rebleeding and of further decompensation of cirrhosis, thus contributing to a better survival. (Hepatology 2017;65:1693-1707).
authors.affiliation: Gastrointestinal Bleeding Unit, Department of Gastroenterology, Hospital de Sant Pau, Barcelona, Autonomous University, Barcelona, Spain.|Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Lleida, Spain.
authors.forename: Càndid
authors.initials: C
authors.lastname: Villanueva
authors.affiliation: Gastrointestinal Bleeding Unit, Department of Gastroenterology, Hospital de Sant Pau, Barcelona, Autonomous University, Barcelona, Spain.|Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Lleida, Spain.
authors.forename: Isabel
authors.initials: I
authors.lastname: Graupera
authors.affiliation: Departmant of Gastroenterology, Hospital Arnau de Vilanova, Lleida, Spain.
authors.forename: Carles
authors.initials: C
authors.lastname: Aracil
authors.affiliation: Gastrointestinal Bleeding Unit, Department of Gastroenterology, Hospital de Sant Pau, Barcelona, Autonomous University, Barcelona, Spain.
authors.forename: Edilmar
authors.initials: E
authors.lastname: Alvarado
authors.affiliation: Departmant of Gastroenterology, Hospital Arnau de Vilanova, Lleida, Spain.
authors.forename: Josep
authors.initials: J
authors.lastname: Miñana
authors.affiliation: Gastrointestinal Bleeding Unit, Department of Gastroenterology, Hospital de Sant Pau, Barcelona, Autonomous University, Barcelona, Spain.
authors.forename: Ángela
authors.initials: Á
authors.lastname: Puente
authors.affiliation: Gastrointestinal Bleeding Unit, Department of Gastroenterology, Hospital de Sant Pau, Barcelona, Autonomous University, Barcelona, Spain.
authors.forename: Virginia
authors.initials: V
authors.lastname: Hernandez-Gea
authors.affiliation: Gastrointestinal Bleeding Unit, Department of Gastroenterology, Hospital de Sant Pau, Barcelona, Autonomous University, Barcelona, Spain.
authors.forename: Alba
authors.initials: A
authors.lastname: Ardevol
authors.affiliation: Gastrointestinal Bleeding Unit, Department of Gastroenterology, Hospital de Sant Pau, Barcelona, Autonomous University, Barcelona, Spain.|Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Lleida, Spain.
authors.forename: Oana
authors.initials: O
authors.lastname: Pavel
authors.affiliation: Gastrointestinal Bleeding Unit, Department of Gastroenterology, Hospital de Sant Pau, Barcelona, Autonomous University, Barcelona, Spain.|Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Lleida, Spain.
authors.forename: Alan
authors.initials: A
authors.lastname: Colomo
authors.affiliation: Gastrointestinal Bleeding Unit, Department of Gastroenterology, Hospital de Sant Pau, Barcelona, Autonomous University, Barcelona, Spain.
authors.forename: Mar
authors.initials: M
authors.lastname: Concepción
authors.affiliation: Gastrointestinal Bleeding Unit, Department of Gastroenterology, Hospital de Sant Pau, Barcelona, Autonomous University, Barcelona, Spain.
authors.forename: María
authors.initials: M
authors.lastname: Poca
authors.affiliation: Gastrointestinal Bleeding Unit, Department of Gastroenterology, Hospital de Sant Pau, Barcelona, Autonomous University, Barcelona, Spain.
authors.forename: Xavier
authors.initials: X
authors.lastname: Torras
authors.affiliation: Departmant of Gastroenterology, Hospital Arnau de Vilanova, Lleida, Spain.
authors.forename: Josep M
authors.initials: JM
authors.lastname: Reñe
authors.affiliation: Gastrointestinal Bleeding Unit, Department of Gastroenterology, Hospital de Sant Pau, Barcelona, Autonomous University, Barcelona, Spain.|Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Lleida, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Guarner
mesh_terms: D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage*; D000368:Aged; D004359:Drug Therapy, Combination; D016099:Endoscopy, Gastrointestinal; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D006801:Humans; D006975:Hypertension, Portal / Q000150:complications / Q000188:drug therapy*; D007548:Isosorbide Dinitrate / Q000008:administration & dosage / Q000031:analogs & derivatives; D008103:Liver Cirrhosis / Q000150:complications* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D017082:Portal Pressure; D012008:Recurrence; D013030:Spain / Q000453:epidemiology
chemical_list: D000319:Adrenergic beta-Antagonists; D007548:Isosorbide Dinitrate; C030397:isosorbide-5-mononitrate