Original article
Pancreas, biliary tract, and liver
Multicenter External Validation of Risk Stratification Criteria for Patients With Variceal Bleeding

https://doi.org/10.1016/j.cgh.2017.04.042Get rights and content

Background & Aims

Early placement of a transjugular intrahepatic portosystemic shunts (TIPS) is considered the treatment of choice for patients with acute variceal bleeding (AVB) and cirrhosis who have a high risk of death (Child–Pugh class B with active bleeding at endoscopy or Child–Pugh class C). It has been proposed that patients of Child–Pugh class B, even with active bleeding, should not be considered high risk. Alternative criteria have been proposed for identification of high-risk patients, such as Child–Pugh class C with plasma level of creatinine of 1 mg/dL or more (ChildC-C1) and a model for end-stage liver disease (MELD) score of 19 or more. We analyzed outcomes of a large cohort of patients with AVB who received the standard of care at different centers to validate these systems of risk stratification.

Methods

We performed an observational study of 915 patients with liver cirrhosis and AVB who received standard treatment (drugs, antibiotics, and endoscopic ligation, with TIPS as the rescue treatment), over different time periods between 2006 and 2014 in Canada and Europe. All patients were followed until day 42 (week 6) after index AVB or death. Child–Pugh and MELD scores were calculated at time of hospital admission. The primary outcome was mortality 6 weeks after index AVB among patients who met the early TIPS criteria (Child–Pugh class B with active bleeding at endoscopy or Child–Pugh class C), MELD19 criteria (patients with MELD scores of 19 or more), and ChildC-C1 criteria.

Results

Among 915 patients with AVB, 18% died within 6 weeks. Among the 523 patients who met the early TIPS criteria, 17% died within 6 weeks. All 3 rules discriminated patients at high risk of death from those with low risk: 28.3% of the patients classified as high risk by the early TIPS criteria died whereas only 7.0% of patients classified as low risk died; 46.0% of patients classified as high risk by the MELD19 criteria died vs 8.1% of patients classified as low risk; 51.9% of patients classified as high risk by the ChildC-C1 criteria died compared with 10.9% of patients classified as low risk. Mortality was significantly lower among patients with Child–Pugh class B (11.7%) than with Child–Pugh class C (35.6%) (P ≤ .001). Mortality was similar between patients with Child–Pugh class B cirrhosis with or without active bleeding (11.7%). Patients with Child–Pugh class A cirrhosis or MELD scores of 11 or less had low mortality (2%–4%), patients with Child–Pugh class B cirrhosis or MELD scores of 12 to 18 had intermediate mortality (10%–12%), and patients with Child–Pugh class C cirrhosis or MELD scores of 19 or more had high mortality (22%–46%).

Conclusions

Patients with Child–Pugh class B cirrhosis and AVB who receive standard therapy, regardless of the presence of active bleeding, have 3-fold lower mortality than patients with Child–Pugh C cirrhosis and might not need TIPS. Patients with Child–Pugh class C and/or MELD scores of 19 or more should be considered at high risk of death. These findings might help refine criteria for early TIPS.

Section snippets

Study Design and Data Collection

The study was conceived as an observational, multicenter, international, validation cohort study based on the analysis of previously collected clinical data from patients from the participating centers. The study cohort was assembled by pooling already collected individual data from published studies on the prognosis of 4 different groups from Canada (Alberta University, Edmonton), Italy (Ospedalle Cardarelli, Naples), and Spain (Hospital Universitari Bellvitge and Hospital Universitari Vall

Patients and Treatments

A total of 915 patients fulfilled the inclusion criteria. The main outcome (6-week mortality) was not available in 11 patients. The remaining 904 patients were included for evaluation (288 from Naples, 269 from Alberta, 215 from Bellvitge-Barcelona, and 132 from Vall d’Hebron-Barcelona). Baseline characteristics of patients and therapies for the whole cohort are detailed in Supplementary Table 3. For a description of the patients from each individual center see Supplementary Table 4.

Thus,

Discussion

The efficacy and safety of the early TIPS approach for high-risk patients with AVB was shown clearly in the original early TIPS trials8 and has been confirmed afterward.9, 16 However, the definition of high-risk patients in this setting is still a matter of debate. More specifically, the consideration of Child–Pugh B patients as high risk has been questioned.10, 11, 14 As a consequence, several alternatives to the original early TIPS criteria have been proposed. Among these, the ChildC-C1 rule

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Conflicts of interest The authors disclose no conflicts.

Funding Irene Conejo is a PhD student at the Universitat Autònoma de Barcelona, Barcelona, Spain and is supported by Hospital Universitari Vall d'Hebron. Salvador Augustin is a recipient of a Juan Rodés grant from the Instituto de Salud Carlos III and Joan Genescà is a recipient of a Research Intensification grant from the Instituto de Salud Carlos III, Madrid, Spain. This study was partially funded by grants PI13/01289, PI14/00331, PI15/00066 and PI17/00310 from the Instituto de Salud Carlos III, and co-financed by the European Regional Development Fund/European Social Fund (ERDF/ESF, “Investing in your future”). The Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd) is supported by the Instituto de Salud Carlos III.

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