"Anticipant"-TIPS After a First Portal-hypertension-related Complication in Cirrhosis

TIPS is now well-validated in patients with: refractory variceal bleeding (VB), failure of VB secondary prophylaxis, recurrent/refractory ascites and in patients with acute VB at high risk of recurrence (pre-emptive TIPS). Further decompensation (FD) in cirrhosis represents a prognostic stage associated with an even higher mortality than that associated with the first decompensation. The Baveno VII conference defined FD as a second portal hypertension (PH)-driven decompensating event (ascites, VB, or hepatic encephalopathy) and/or jaundice, or development of spontaneous bacterial peritonitis and/or hepatorenal syndrome. In the above validated indications of TIPS, the present team has coordinated an IPD meta-analysis including 3924 patients that showed that the cumulative incidence of FD was 0.45 (0.41-0.49) in the TIPS group vs. 0.63 (0.60-0.66) in a in a standard of care (SOC) group (p\<0.0001). The 2-year cumulative survival was higher with TIPS than with SOC (0.71 vs 0.63; p=0.0001). Finally, one small retrospective study including 27 patients showed that "anticipant TIPS", performed after a first VB or a significant episode of ascites, improved 1-year survival in comparison to conventional TIPS (i.e after recurrence): 82% vs 40%. Patients will be randomly allocated to TIPS or SOC (diuretics and large volume paracentesis LVP when needed in patients with ascites or non-selective betablocker + band ligation in patients with variceal bleeding). Patients will be followed at one month and every three months within two years, thereafter.