Predicting survival in patients with 'non-high-risk' acute variceal bleeding receiving β-blockers+ligation to prevent re-bleeding.

BACKGROUND&AIMS Pre-emptive transjugular intrahepatic portosystemic shunt (TIPS) is the treatment of choice in high-risk acute variceal bleeding (AVB; i.e., Child-Turcotte-Pugh [CTP] B8-9+active bleeding/C10-13). Nevertheless, 'non-high-risk' patients with poor outcomes remain despite the combination of non-selective beta-blockers (NSBB) and endoscopic variceal ligation (EVL) for secondary prophylaxis. We investigated prognostic factors for re-bleeding and mortality in 'non-high-risk' AVB to identify subgroups who may benefit from more potent treatments (i.e., TIPS) to prevent further decompensation and mortality. METHODS 2225 adults with cirrhosis and variceal bleeding were prospectively recruited at 34 centres between 2011-2015; for the purpose of this study, case definitions and information on prognostic indicators at index AVB and on day 5 were further refined in low-risk patients. 581 well-characterised low-risk patients without failure to control bleeding or TIPS contraindications who were managed by NSBB/EVL were finally included. Patients were followed for one year. RESULTS Overall, 90 patients (15%) re-bled and 70 (12%) patients died during follow-up. Using clinical routine data, no meaningful predictors of re-bleeding were identified. However, re-bleeding (included as a time-dependent co-variable) increased mortality, even after accounting for differences in patient characteristics (adjusted cause-specific hazard ratio:2.57[95%CI:1.43-4.62];p=0.002). A nomogram including CTP, creatinine, and sodium measured at baseline accurately (concordance: 0.752) stratified the risk of death. CONCLUSION The majority of 'non-high-risk' patients with AVB have an excellent outcome, if treated according to current recommendations. However, about one fifth of patients, i.e., those with CTP ≥8 and/or high creatinine levels or hyponatremia, have a considerable risk of death within 1 year of the index bleed. Future clinical trials should investigate whether elective TIPS placement reduces mortality in these patients