Stratifying risk in the prevention of recurrent variceal hemorrhage: Results of an individual patient meta-analysis.
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Endoscopic variceal ligation plus beta-blockers (EVL+BB) is currently recommended for variceal rebleeding prophylaxis, a recommendation that extends to all patients with cirrhosis with previous variceal bleeding irrespective of prognostic stage. Individualizing patient care is relevant and, in published studies on variceal rebleeding prophylaxis, there is a lack of information regarding response to therapy by prognostic stage. This study aimed at comparing EVL plus BB with monotherapy (EVL or BB) on all-source rebleeding and mortality in patients with cirrhosis and previous variceal bleeding stratified by cirrhosis severity (Child A vs. B/C) by means of individual time-to-event patient data meta-analysis (IPD) from randomized controlled trials. The study was IPD of 389 patients from 3 trials comparing EVL plus BB vs. BB and 416 patients from 4 trials comparing EVL plus BB vs. EVL. Compared with BB alone, EVL plus BB reduced overall rebleeding in Child A (incidence rate ratio 0.40; 95%CI 0.18-0.89; p=0.025), but not in Child B/C, without differences in mortality. The effect of EVL on rebleeding was different according to Child (p for interaction <0.001). Conversely, compared with EVL, EVL plus BB reduced rebleeding in both Child A and B/C, with a significant reduction in mortality in Child B/C (incidence rate ratio 0.46; 95%CI 0.25-0.85; p=0.013). CONCLUSION: Outcomes of therapies to prevent variceal rebleeding differ depending on cirrhosis severity. In patients with preserved liver function (Child A), combination therapy is recommended since it is more effective in preventing rebleeding, without modifying survival. In patients with advanced liver failure (Child B/C), EVL alone carries an increased risk of rebleeding and death as compared with combination therapy, underlining that BB is the key element of combination therapy. This article is protected by copyright. All rights reserved.