Reuters Health Information (2010-06-23): Early use of TIPS controls variceal bleeding in severe cirrhosis
Early use of TIPS controls variceal bleeding in severe cirrhosis
Last Updated: 2010-06-23 17:24:12 -0400 (Reuters Health)
NEW YORK (Reuters Health) - In patients with severe cirrhosis and acute variceal bleeding, employ transjugular intrahepatic portosystemic shunts (TIPS) early instead of waiting to see whether pharmacotherapy will work, a randomized trial suggests.
Some patients in the study received TIPS right away while others received it after medical therapy had failed. In the latter circumstance, TIPS was 100% effective at controlling bleeding, "but around 50% of patients died of liver failure," lead investigator Dr. Juan Carlos Garcia-Pagan told Reuters Health by e-mail.
Dr. Garcia-Pagan, from the University of Barcelona, Spain, and colleagues at nine European centers enrolled 63 patients with Child-Pugh class C disease or class B disease with active bleeding.
All the patients had endoscopic band ligation or injection sclerotherapy within 12 hours of admission along with vasoactive drugs, according to the study report, published online June 24th in the New England Journal of Medicine.
The authors randomly assigned 32 patients to undergo TIPS within 72 hours using a stent covered with extended polytetrafluoroethylene (e-PTFE). The 31 patients in the control group continued to receive vasoactive drug therapy, followed after several days by propranolol or nadolol and long term endoscopic band ligation. They could have TIPS as rescue therapy.
The primary endpoint -- rebleeding or failure to control bleeding -- occurred in 14 patients in the control group during a median follow-up of 16 months, compared with one patient in the early-TIPS group (p = 0.001). The number needed to treat to prevent this primary endpoint was 2.1.
Twelve patients in the control group and four in the early-TIPS group died within a year (p = 0.001). The number needed to treat to prevent one death was 4.0.
Out of the 14 patients in the control group with rebleeding or failure to control bleeding, 7 had TIPS as rescue therapy; 4 of these 7 died within 36 days. In another 5 of the 14, the severity of their liver disease precluded further treatment; they died as well. The nine who died had a mean Model for End Stage Liver Disease (MELD) score of 28 when they reached the primary endpoint. (The MELD score ranges from 6 to 40, with higher scores indicating more severe disease.) By comparison, at baseline -- when the intervention group had TIPS -- the mean MELD score was 19.
Worsening of liver failure appears to be the determinant of the poor outcome after rescue TIPS, senior author Dr. Jaime Bosch, also from the University of Barcelona, told Reuters Health. "Despite controlling the bleeding, the patient dies since he has deteriorated too much," he said. "'Treatment was a success, but the patient died,' what has been called 'Success Rate vs. Funeral Rate.'"
He continued, "Our findings suggest that patients with variceal bleeding and high risk indicators should be managed in centers that can provide emergency TIPS."
N Engl J Med 2010;362:2370-2379.