The addition of cardiac resynchronization therapy to treatment with a basic implantable cardioverter-defibrillator reduced hospitalization and death rates among patients with heart failure, data from the RAFT trial indicate.
Anthony S. L. Tang, MD, of the University of Ottawa Heart Institute and colleagues from Australia, Canada, Europe and the United States, enrolled 1,798 patients who had New York Heart Association class II or III heart failure. They aimed to determine whether there were specific benefits to adding CRT to patients already fitted with an ICD in one of the largest-ever medical device trials.
All patients had left ventricular systolic dysfunction and a wide QRS complex, and were assigned to treatment with either an ICD (n=904) or both an ICD and CRT (n=894).
After a 40-month follow-up period, the researchers determined that fewer patients in the ICD-CRT group died (186 vs. 236; HR=0.75; 95% CI: 0.62-0.91; P=.003) or were hospitalized (174 vs. 236; HR=0.68; 95% CI: 0.56-0.83; P<.001) compared to those in the ICD-only group.
“Until now there has been no evidence that CRT offers survival benefit beyond that provided by an ICD,” the researchers wrote.
Yet despite these benefits, more patients in the ICD-CRT group experienced device-related adverse events 30 days after implantation compared to those who had an ICD alone (124 vs. 58; P<.001).
“Left ventricular lead dislodgement and an increased rate of infection remain significant problems,” the researchers wrote. They added that the adverse events observed in the ICD-CRT group “did not have substantial long-term consequences,” but might result in longer hospitalization.
“In the past decade, we have come a long way with combine pharmacological and device therapies that reduce the probability of heart failure and death in at-risk patients with cardiac disease,” Arthur J. Moss, MD, of the University of Rochester School of Medicine and Dentistry in New York, wrote in an accompanying editorial. “We can say that recent findings documenting the use of CRT in preventing heart failure in minimally symptomatic patients are indeed breathtaking. “
RAFT results were published online first in the New England Journal of Medicine and coincided with the release of the analysis at the American Heart Association 2010 Scientific Sessions in Chicago.