The largest ever study of IV iron supplementation in patients with heart failure failed to meet a new rigorous definition of significance, and the results were generally regarded as disappointing.
Another presentation at the ESC Congress reported a pooled meta-analysis of all the IV iron supplementation studies, including HEART-FID. This showed a significant reduction in one co-primary endpoint but not in the other , which is the more traditional and well-recognized endpoint in heart failure trials.HEART-FID lead investigator, Robert J.
"We need to look further into why there is that discrepancy," he said."This could be a statistical phenomenon or could be something to do with the frequency of re-dosing over the longer term." The primary outcome was a hierarchical composite of death within 12 months after randomization, hospitalizations for heart failure within 12 months after randomization, or change from baseline to 6 months in the 6-minute walk distance. The significance level was set at .01.
Repeated dosing of ferric carboxymaltose appeared to be safe, with an acceptable adverse-event profile in most patients. The number of patients with serious adverse events occurring during the treatment period was similar in the two groups .Designated discussant of the HEART-FID study at the ESC HOTLINE session, Scott Solomon, MD, Brigham and Women's Hospital, Boston, Massachusetts, described HEART-FID as"an extremely important and well-conducted trial.
"When we look at the traditional cardiovascular death/heart failure hospitalization endpoint, one of the hard endpoints that we care about most in heart failure, it's hard to argue that we are not disappointed," he commented.value of .01 threshold set for significance, which is based on new U.S. Food and Drug Administration regulatory standards, Solomon noted,"If they had used a standard=.
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