By: M. ALEXANDER OTTO, Internal Medicine News Digital Network
SAN FRANCISCO – The anticoagulant enoxaparin appears to prevent portal vein thrombosis in patients with advanced cirrhosis, based on a small Italian study presented at the annual meeting of the American Association for the Study of Liver Diseases.
In this trial, 6 of 36 patients (17%) randomized to placebo developed partial or complete portal vein thrombosis (PVT) within a year, whereas none of the 34 patients (0%) randomized to 4,000 IU daily of the low-molecular-weight heparin developed PVT.
The analysis indicated that enoxaparin had a significant protective effect (HR 0.218; 95% CI, 0.048-0.994, P = .049) in these patients with advanced cirrhosis.
At enrollment, none of the patients had PVT. The treatment and placebo groups had no significant differences in terms of biochemical or demographic factors at the outset of the trial, which was the first to prospectively investigate whether anticoagulation prevents PVT.
At the meeting, lead investigator Dr. Erica Villa, professor of gastroenterology at the University of Modena and Reggio Emilia in Modena, Italy, said that the results need to be confirmed in larger studies.
All of the subjects had cirrhosis classified as Child-Pugh B7 to C10. The mean age in both groups was 57 years, and the mean MELD (Model for End-Stage Liver Disease) score was approximately 14. Men made up more than 60% of both arms.
Enoxaparin appeared to provide significant protection against decompensation – defined as new-onset ascites, hepatic encephalopathy, or variceal bleeding – and death. Four enoxaparin patients (12%) decompensated during treatment, whereas 22 (61%) in the placebo arm decompensated. The difference persisted even after treatment with enoxaparin ended at 12 months.
Similarly, although 10 patients died in the enoxaparin group – 4 from sepsis, 2 from progressive liver failure, 3 from hepatocellular carcinoma, and 1 from variceal bleeding – 16 died in the placebo group. These deaths were due to sepsis in seven patients, progressive liver failure in another seven, hepatocellular carcinoma in one, and variceal bleeding in one.
There were no hemorrhagic or other treatment-related adverse events in the enoxaparin group, although asymptomatic thrombocytopenia led to the withdrawal of one patient 3 months into the trial. Three enoxaparin patients had liver transplants while on the drug, and Dr. Villa noted that they did not need extra blood transfusions.
Dr. Villa said she had no disclosures. She said the study was funded internally, and not by a company that makes enoxaparin.
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A Possible Sea Change in Cirrhosis Treatment
Enoxaparin "could certainly become a treatment for people who are at high risk for portal vein thrombosis. We don’t know enough about this; there may be side effects just like with other drugs, but [the findings are] exciting," said Dr. Jake Liang.
If this approach holds up to additional testing, it would signal "a sea change" in the treatment of advanced cirrhosis. "We treat thousands of people with cirrhosis; this would advocate that you should put them on this very expensive medicine" even if there’s no evidence of PVT, said Dr. Willscott Naugler.
Dr. Naugler is assistant professor of medicine at Oregon Health and Science University in Portland. Dr. Liang is president of the American Association for the Study of Liver Diseases and chief of the liver diseases branch of the National Institute of Diabetes and Digestive and Kidney Diseases
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