Background: Emergency treatment of bleeding esophageal varices (BEV) in cirrhosis is of paramount importance because of the resultant high mortality rate. Emergency therapy today consists mainly of endoscopic and pharmacologic measures, with use of transjugular intrahepatic portosystemic shunt (TIPS) when bleeding is not controlled. Surgical portosystemic shunt has been relegated to last resort salvage when all other measures fail. Regrettably, no randomized controlled trials have been reported in which TIPS and surgical portosystemic shunt were compared in unselected patients with acute BEV, with long-term follow-up. This is a report of a long-term prospective randomized controlled trial (RCT) that compared TIPS with emergency portacaval shunt (EPCS) in patients with cirrhosis and acute BEV.
Study design: A total of 154 unselected, consecutive cirrhotic patients ("all comers") with acute BEV were randomized to TIPS (n = 78) or EPCS (n = 76), and the two treatments were compared with regard to effect on survival, control of bleeding, portal-systemic encephalopathy (PSE), and disability. Diagnostic workup was completed within 6 h and TIPS or EPCS was initiated within 24 h. Regular follow-up was accomplished in 100 % of patients and lasted for 5 to 10 years in 85 % and 3 to 4.5 years in the remainder. This report focuses on control of bleeding and survival.
Results: The clinical characteristics of the two groups were similar, and the distribution of Child classes A, B, and C was almost identical. TIPS was successful in controlling BEV for 30 days in 80 % of patients but achieved long-term control of BEV in only 22 %. In contrast, EPCS controlled BEV immediately in all patients and permanently in 97 % (p < 0.001). TIPS patients required almost twice as many units of blood transfusion as EPCS patients. Survival rate at all time intervals and in all Child classes was significantly greater following EPCS than after TIPS (p < 0.001). Median survival was over 10 years following EPCS, compared to 1.99 years following TIPS. Stenosis or occlusion of TIPS was demonstrated in 84 % of patients who survived 21 days, 63 % of whom underwent TIPS revision, which failed in 80 %. In contrast, EPCS remained permanently patent in 97 % of patients. Recurrent PSE was threefold more frequent following TIPS than after EPCS (61 versus 21 %).
Conclusions: EPCS was uniformly effective in the treatment of BEV, while TIPS was disappointing. EPCS accomplished long-term survival while TIPS resulted in a survival rate that was less than one fifth that of EPCS. The results of this RCT in unselected, consecutive patients justify the use of EPCS as a first-line emergency treatment of BEV in cirrhosis (clinicaltrials.gov #NCT00734227).