SEATTLE — Immune modulation therapy for patients with chronic heart failure did not reduce deaths or hospitalizations but was helpful in two subsets of patients in a 2,426-patient trial, Dr. Guillermo Torre-Amione reported.
Prespecified subgroup analyses found fewer deaths or hospitalizations with Celacade immune modulation therapy than with placebo in patients with New York Heart Association (NYHA) class II heart failure and in patients with class III-IV heart failure but no history of MI, he said at the annual meeting of the Heart Failure Society of America.
The randomized, double-blind, placebo-controlled Advanced Chronic Heart Failure Clinical Assessment of Immune Modulation Therapy (ACCLAIM) trial showed that the Celacade technology was safe and well tolerated and “helpful in heart failure from nonischemic etiology, and in patients with ischemic etiology who have not yet reached more advanced disease stages,” said Dr. Torre-Amione, medical director at the Methodist DeBakey Heart Center, Houston, and his associates.
Dr. Torre-Amione has received honoraria and research funding from Vasogen Inc., which funded the trial and owns the experimental Celacade technology.
Celacade therapy targets the chronic inflammation associated with cardiovascular disease. Samples of whole blood taken from patients randomized to Celacade therapy were subjected to oxidative stress and returned to patients via intramuscular injection. The oxidative stress induces cell apoptosis and triggers other reactions that increase production of anti-inflammatory cytokines and regulatory T cells that help reduce chronic inflammation, the investigators said.
Outpatient treatment with the 10-mL blood samples took place on days 1, 2, and 14, then every 30 days for 22 weeks or longer during June 2003-November 2005. All patients were on standard medications for heart failure, as tolerated. The mean follow-up in the study was 10 months.
There was no significant difference at 600 days between the Celacade and placebo groups in the primary combined end point of death from any cause or hospitalization for cardiovascular reasons. Quality-of-life scores were significantly better in the Celacade group than in placebo patients in preplanned analyses of secondary end points. The number of serious adverse events was similar between groups, as was the number of patients with more than one serious adverse event.
Among 900 patients with no prior MI, however, there were 26% fewer deaths or cardiovascular hospitalizations with Celacade compared with placebo, and patients fared better on secondary end points with Celacade as well, Dr. Torre-Amione said.
Among 700 patients with NYHA class II heart failure, there were 29% fewer deaths or cardiovascular hospitalizations with Celacade compared with placebo.
In a separate analysis of a combined group of 1,300 patients (about half of all patients in the study) with either class II heart failure or class III-IV but no history of MI, there were 165 deaths or heart failure hospitalizations in the Celacade group, compared with 226 in the placebo group, a highly statistically significant difference. In addition, the Celacade group had fewer mean days in the hospital for heart failure or for any cause, he said.
The study took place in 177 centers in North America, Europe, and Israel. Patients predominantly were white males and had a mean age of 64 years. All had a baseline ejection fraction of 30% or less and prior hospitalization (or outpatient treatment with IV medication) for heart failure within the previous 12 months. Sixty-two percent of patients had a history of MI.