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| |  Fractionated Plasma Separation and Adsorption Provides Survival Benefits for Acute-on-Chronic Liver Failure: Presented at EASL 2010 By Chris Berrie VIENNA, Austria -- April 16, 2010 -- Significant survival benefits are seen in patients with acute-on-chronic liver failure receiving extracorporeal liver support therapy by fractionated plasma separation and adsorption (FPSA) combined with standard medical therapy (SMT) over SMT alone, researchers stated at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL 2010). This combined liver support system allows extracorporeal removal of protein-bound toxins by direct adsorption and removal of water-soluble toxins by haemodialysis, explained coprincipal investigator Kinan Rifai, MD, PhD, Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany, speaking here on April 15. Dr. Rifai presented the results of this prospective, randomised, controlled trial on behalf of the Prometheus European Liver Disease Outcome Study (HELIOS) Group The objective of the study was to compare patient survival with the addition of FPSA to SMT in patients with acute decompensation of chronic liver disease. Patients all had a high Model for End-Stage Liver Disease (MELD) score or hepatorenal syndrome type 1. "Furthermore, the patients [had to] present with a Child-Pugh score [CPS] of at least 10 points and a bilirubin of at least 5 mg/dL," added Dr. Rifai. Following stratification for hepatorenal syndrome, the patients were randomised to SMT alone over 90 days, or the same SMT with 21 days of FPSA. The primary outcome was patient survival on day 28 (treatment phase) and day 90 (follow-up phase). FPSA treatment was given in three 7-day treatment blocks, providing 8 to 11 treatments over 21 days, with each treatment lasting for 4 hours or more. At the preplanned interim analysis of the first 90 patients, there was no significant benefit over SMT for addition of FPSA for patient survival (65% vs 61%, respectively), and hence the study was terminated following the inclusion of 145 patients. This provided an intention-to-treat patient population of 68 subjects with SMT alone (mean age, 51 years; male, 65%) and 77 with SMT+FPSA (mean age, 50 years; male, 62%). The chronic liver disease was mainly due to alcohol abuse (65% vs 48%) and viral hepatitis (21% vs 20%). These patients showed similar average MELD scores (27 vs 28), CPS (12 vs 12), Sequential Organ Failure Assessment (SOFA) scores (10 vs 10), underlying comorbidities, and precipitating events. Patient survival for SMT or SMT+FPSA was not significantly different both at day 28 (63% vs 66%) and at day 90 (38% vs 47%). There was, however, a trend for improved survival benefit for patients who remained on maximum FPSA treatment until death (log rank P = .08). In a predefined subgroup analysis, patients with baseline MELD score over 30 appeared to show improved survival over SMT for addition of FPSA on day 28 (15%), which was significant on day 90 (39%; P = .02; log rank P = .0241). Furthermore, in another predefined subgroup analysis, similar benefits were seen for patients with hepatorenal syndrome type 1, although Dr. Rifai noted that these patients were all also treated with terlipressin. There was an apparent survival benefit in favour of FPSA addition on day 28 (23%) that was increased and significant on day 90 (36%; P = .04; log rank P = .0410). With the multivariate Cox model analysis, as well as a MELD score over 30 showing significant survival benefit (hazard ratio, 0.47; 95% confidence interval [CI], 0.22-0.99), Dr. Rifai noted, "The strongest independent risk factor regarding patient survival was the SOFA score, with a hazard ratio of 1.23 [95% CI, 1.13-1.33] per SOFA score unit." In the safety analysis, although there were large numbers of adverse events due to comorbidities and disease severity, there were no significant differences in the numbers and types seen across the 2 treatment groups. Funding for this study provided by Fresenius Medical Care. [Presentation title: Extracorporeal Liver Support by Fractionated Plasma Separation and Adsorption (Prometheus ) in Patients With Acute-on-Chronic Liver Failure (HELIOS Study): a Prospective Randomized Controlled Multicenter Study. Abstract 6]
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