Early TIPS improves outcomes in cirrhosis with variceal bleeding

Last Updated: 2019-06-11

By Will Boggs MD

NEW YORK (Reuters Health) - Early use of transjugular intrahepatic portosystemic shunts (TIPS) improves outcomes and should become the standard of care in patients with advanced cirrhosis and acute variceal bleeding, researchers from China say.

"Among patients with advanced cirrhosis (Child-Pugh class B or C) and acute variceal bleeding, early TIPS is superior to drugs plus endoscopic treatment in improving transplantation-free survival," said Dr. Guohong Han from Xijing Hospital, Fourth Military Medical University, in Xi'an.

"Our results, observed in patients of Asian ethnicity with cirrhosis of viral etiology, are consistent with those of earlier European trials where most patients had alcoholic liver cirrhosis, suggesting that ethnicity and etiology of cirrhosis did not obviously influence the results," he told Reuters Health by email.

In the 10% to 20% of patients with acute variceal bleeding who experience treatment failure with the current standard of care (vasoactive drugs, prophylactic antibiotics, and endoscopic therapy), TIPS placement results in hemostasis in 90% to 100% of patients, but six-week mortality can be as high as 55%.

Dr. Han and colleagues evaluated whether early TIPS (within 72 hours after hospital admission) improves transplantation-free survival, compared with the standard care, in their open-label, randomized trial of 132 patients with advanced cirrhosis and acute variceal bleeding.

In the early TIPS group, the mean portacaval pressure gradient decreased from 24.4 mm Hg before TIPS to 8.3 mm Hg immediately after TIPS, with only 11 patients (13%) having a pressure gradient greater than 12 mm Hg.

During follow-up (median, 24.0 months in both groups), 15 patients (18%) in the early TIPS group and 15 patients (33%) in the control group died, and 2% of patients in each group received a liver transplant.

Actuarial transplantation-free survival was significantly higher in the early TIPS group than in the control group at six weeks (99% vs. 84%, respectively), at one year (86% vs. 73%) and at two years (79% vs. 64%).

Early TIPS was the only independent predictor of improved all-cause mortality or transplantation, while Model for End-Stage Liver Disease (MELD) score was an independent predictor of worse all-cause mortality or transplantation, the researchers report in The Lancet Gastroenterology and Hepatology, online May 29.

The actuarial probability of remaining free from uncontrolled bleeding or rebleeding was significantly higher in the early TIPS group than in the control group at one year and at two years, as was the actuarial probability of remaining free from new or worsening ascites.

Serious and nonserious adverse events occurred in a similar proportion of patients in the two treatment groups.

It remains unclear which patients would benefit most from early TIPS. "However," Dr. Han said, "our previous large multicenter observational study showed that the survival benefit provided by early TIPS was modified by the baseline risk profile, and patients with a higher MELD score or Child-Pugh score benefited the most from early TIPS."

"There is now no doubt about the benefit of pre-emptive TIPS in patients with Child-Pugh C disease," write Dr. Dominique Thabut and Dr. Marika Rudler from AP-HP, Groupe Hospitalier Pitie-Salpetriere-Charles Foix and Sorbonne Universites, in Paris, in a linked editorial. "The beneficial effects of pre-emptive TIPS on ascites should push us to consider this approach in all patients, in the absence of contraindication."

"The greatest remaining concern is the applicability of TIPS in general practice, even in China," they conclude. "Hepatologists must work together to perform well-designed studies in expert centers to accumulate sufficient evidence to refine the criteria for pre-emptive TIPS and to standardize indications, procedures, and follow-up, to fully convince the general medical community."

SOURCE: https://bit.ly/2I9b5Mv and https://bit.ly/2XC3Lyp

Lancet Gastroenterol Hepatol 2019.