Expanded abstractCitationGarcía-Pagán JC, Caca K, Bureau C, Laleman W, Appenrodt B, Luca A, Abraldes JG, Nevens F, Vinel JP, Mössner J, Bosch J; Early TIPS (Transjugular Intrahepatic Portosystemic Shunt) Cooperative Study Group: Early use of TIPS in patients with cirrhosis and variceal bleeding. N Engl J Med 2010, 362:2370-2379.BackgroundPatients with Child-Pugh class C or class B cirrhosis and persistent bleeding at endoscopy are at high risk for treatment failure and a poor prognosis. This study evaluated the early use of a transjugular intra hepatic portosystemic shunt (TIPS) in such patients.MethodsObjectiveThe study was conducted to determine whether early treatment with extended polytetrafluoroethylene (e-PTFE) can improve outcomes in patients who have cirrhosis and acute variceal bleeding and who are at high risk for treatment failure and death.DesignThe study was a randomized clinical trial.SettingThe study was conducted at nine European centers.SubjectsEligible patients had cirrhosis with acute esophageal variceal bleeding. Patients had Child-Pugh class C disease (a score of 10 to 13) or class B disease (a score of 7 to 9) but with active bleeding at diagnostic endoscopy.InterventionsEndoscopic band ligation (EBL) or endoscopic injection sclerotherapy was applied at the time of diagnostic endoscopy in all patients and was performed within 12 hours after admission while the patients were already receiving vasoactive drugs.Pharmacotherapy-EBL group: Treatment with vasoactive drugs was continued until patients were free of bleeding for at least 24 hours and preferably up to 5 days, at which point treatment with a non-selective beta-blocker and, subsequently, oral nitrate therapy was started.Early-TIPS group: TIPS was performed within 72 hours after diagnostic endoscopy (or, if possible, within the first 24 hours), and vasoactive drugs were administered until then.OutcomesThe primary end-point of the study was a composite outcome of failure to control acute bleeding or failure to prevent clinically significant variceal re-bleeding within 1 year after enrollment. Secondary end-points included mortality at 6 weeks and at 1 year.ResultsDuring a median follow-up of 16 months, re-bleeding or failure to control bleeding occurred in 14 patients in the pharmacotherapy-EBL group and in one patient in the early-TIPS group (P = 0.001). The 1-year actuarial probabilities of remaining free of this composite endpoint were 50% in the pharmacotherapy-EBL group and 97% in the early-TIPS group (P <0.001). Sixteen patients died (12 in the pharmacotherapy-EBL group and four in the early-TIPS group; P = 0.01). The 1-year actuarial survival rates were 61% in the pharmacotherapy-EBL group and 86% in the early-TIPS group (P <0.001). Seven patients in the pharmacotherapy-EBL group received TIPS as rescue therapy, but four died. The number of days in the intensive care unit and the percentage of time in the hospital during follow-up were significantly higher in the pharmacotherapy-EBL group than in the early-TIPS group. No significant differences with respect to serious adverse events were observed between the two treatment groups.ConclusionsIn the cirrhosis patients who were hospitalized for acute variceal bleeding and were at high risk for treatment failure, the early use of TIPS was associated with significant reductions in treatment failure and in mortality.