(Circulation. 2001;103:e9030.)
© 2001 American Heart Association, Inc.
50th Annual Scientific Sessions of the American College of Cardiology
Angiogenesis Results Positive
Treatment with the angiogenesis-promoting fibroblast growth factor 2 (FGF-2), given intra-arterially, increased exercise tolerance in patients with intermittent claudication in a study presented by Robert J. Lederman, MD, of the National Heart, Lung and Blood Institute at the 50th Annual Scientific Sessions of the American College of Cardiology, March 18 through 21, 2001, in Orlando, Florida.
The study involved 190 patients who were randomized to 1 of the following 3 groups: a single 30-µg/kg dose of FGF-2, two 30-µg/kg doses of FGF-2 given 30 days apart, and placebo. The study, which was called the Therapeutic Angiogenesis with FGF-2 For Intermittent Claudication (TRAFFIC), measured the patient’s peak walking time at baseline and at 90 days. Dr Lederman was at the University of Michigan in Ann Arbor at the time that this study was done.
At 90 days, placebo patients increased their walking time
0.6 minutes, which is 
14% over baseline, indicating a strong
placebo effect in the trial. Patients who received a single dose of the
protein increased their walking time 1.77 minutes, which is a 34%
increase over baseline, and the double-dose group walked 1.54 minutes
longer, which is a 20% increase. Dr Lederman said the increase was
statistically significant for both treatment groups. "But double is
not better than single," he said, a result that was surprising.
However, the trial does prove the value of this agent in improving the
treadmill performance of these patients.
In contrast to Dr Lederman’s study, the Angiogenic Gene
Therapy Trial for Stable Angina