New ACCLAIM trial data show that Celacade anti-inflammatory technology reduces risk of cardiovascular hospitalization or death for a major subgroup of patients with chronic heart failure, according to a presentation at the annual World Congress of Cardiology.

The international ACCLAIM trial studied 2,408 patients with chronic heart failure at 175 clinical centers. Patients had New York Heart Association (NYHA) Class II, III, or IV heart failure with a left ventricular ejection fraction (LVEF) of 30 percent or less and had been hospitalized or received intravenous drug therapy for heart failure within the previous 12 months. Alternatively, patients could have Class III/IV heart failure with an ejection fraction of less than 25 percent. The primary endpoint was first cardiovascular hospitalization or death.

Patients in the ACCLAIM trial were already receiving optimal standard-of-care therapy for heart failure, which at baseline included diuretics (94 percent), angiotensin converting enzyme inhibitors (94 percent), beta blockers (87 percent), automatic implantable cardioverter defibrillators (26 percent), and use of cardiac resynchronization therapy (10.5 percent).

The placebo (1,204 patients) and Celacade (1,204 patients) groups were balanced for all important baseline characteristics, including demographics, left ventricular ejection fraction, NYHA classification, concomitant medical conditions, medications, and device therapies.

Researchers found that Celacade reduced risk for the primary endpoint by 31 percent for over half of all patients, the combined subgroup of Class III/IV patients with no history of myocardial infarction and all Class II patients (total, 1305 patients, 391 events).

"The ACCLAIM results provide compelling evidence that Celacade significantly reduces the risk of death and cardiovascular hospitalization in an important group of heart failure patients that remain underserved by available therapies," stated Guillermo Torre-Amione, MD, PhD, presenter and Principal Investigator for the U.S. arm of the ACCLAIM trial.

"These findings are consistent with the role that chronic inflammation plays in the development and progression of heart failure and are particularly impressive in the large subgroup of NYHA Class III/IV patients who had not experienced a prior heart attack and in all NYHA Class II patients. These results provide a strong basis for targeting Celacade's novel anti-inflammatory mechanism in this large and well-defined patient population."

As previously reported, the difference in time to death or first cardiovascular hospitalization (the primary endpoint) for the intent-to-treat study population was not statistically significant, although risk reduction directionally favored the Celacade group.

The new findings showed that Celacade significantly reduced the risk of death or first cardiovascular hospitalization by 26 percent in patients with non-ischemic heart failure as indicated by no prior history of myocardial infarction at baseline (919 patients, 243 events). It reduced risk for the same primary endpoint by 39 percent for patients with Class II failure at baseline (689 patients, 216 events).

In addition, an exploratory analysis based on pre-specified subgroups, which comprised 72 percent of the patient population and excluded only patients in NYHA Class III/IV with a history of myocardial infarction and ejection fraction equal to or below the median (23 percent), showed that Celacade reduced risk by 21 percent (1,746 patients, 560 events).

"The consistency and strength of the risk reductions seen across a number of large subgroups in ACCLAIM is very compelling, particularly considering that the patients in this trial were receiving the best standard of care of any heart failure trial I have seen published to date," said James Young, MD, Chairman, The Cleveland Clinic Foundation, and Chairman of the Steering Committee for the ACCLAIM trial.

"Of particular interest is the strong finding in the combined subgroup of patients with non-ischemic cardiomyopathy and those with NYHA Class II symptoms regardless of etiology - results that will now drive the commercial development of Celacade. Based on these findings, we now see an opportunity to benefit a large and rapidly growing segment of the heart failure population, where the risk of mortality and morbidity remains unacceptably high."