Researchers at the University of Colorado Health Sciences Center today announced the findings of a large-scale clinical trial for patients with late-stage heart failure. Results showed that cardiac resynchronization therapy (CRT) from implantable pacemaker-like devices or CRT combined with an implantable defibrillator (CRT-D), when used in addition to optimal drug therapy, reduced significantly the mortality and first hospitalization rate when compared to drug therapy alone. CRT-D also substantially lowered mortality.
The findings of this landmark Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure (COMPANION) trial, sponsored by Guidant, will be published in the May 20 issue of the New England Journal of Medicine.
"COMPANION demonstrates for the first time that significantly improved patient outcomes can be achieved with cardiac resynchronization therapy, over and above optimal drug therapy," said Dr. Michael R. Bristow, COMPANION study co-chairman, co-director of the University of Colorado Cardiovascular Institute, and professor and head of the Division of Cardiology at CU-Health Sciences Center.
While previous clinical studies have shown CRT and CRT-D therapies improve quality of life and exercise performance levels, results of the COMPANION Trial show clinically significant reductions in both hospitalizations and mortality in chronic heart failure patients.
"Many of these patients have optimized every drug therapy available," Bristow said. "Despite the development of excellent medical therapy during the past 15 years, heart failure continues to have serious consequences, including high rates of hospitalization, substantial mortality, and poor patient quality of life. The results of COMPANION, which indicate decreases in hospitalizations and deaths for heart failure patients, are incredibly important in as much as the results were obtained when added to the best medical therapy available."
The COMPANION trial, which began in 2000, involved a 1.5-year follow up of more than 1,500 individuals in chronic heart failure who were on randomized treatments. All patients had advanced heart failure, and on average, were age 67.
Those patients who received CRT plus optimal drug therapy during the study had a 19 percent decrease in combined all-cause mortality or first all-cause hospitalizations, compared to patients treated with drug therapy alone.
Subjects who received CRT-D plus drug therapy during that time had a 20 percent decrease in all cause mortality or hospitalizations as compared to those with drug therapy alone, and they also had a highly statistically significant, 36 percent decrease in mortality.
The trial concluded that in patients with advanced heart failure, CRT or CRT-D decreases the combined risk of death from any cause or first hospitalization, and that CRT-D significantly reduces mortality.
According to the American Heart Association, more than 5 million Americans suffer from chronic heart failure, and more than 250,000 die each year. Nearly one million new cases of heart failure are diagnosed annually worldwide, making it the most rapidly growing cardiovascular disorder.