(Circulation. 1999;100:1865-1871.)
© 1999 American Heart Association, Inc.
Clinical Investigation and Reports |
Local Perivascular Delivery of Basic Fibroblast Growth Factor in Patients Undergoing Coronary Bypass Surgery
Results of a Phase I Randomized, Double-Blind, Placebo-Controlled Trial
From the Angiogenesis Research Center (R.J.L., J.D.P., M.S.) and Interventional Cardiology Section (R.J.L.), Department of Medicine, and Department of Surgery (F.W.S.), Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, Mass; Massachusetts Institute of Technology (E.R.E.), Cambridge, Mass; and Departments of Medicine (J.A.W., D.L.B.) and Cardiothoracic Surgery (J.P.G.), Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, NY.
Correspondence to Michael Simons, MD, Angiogenesis Research Center, Harvard Medical School, Beth Israel Deaconess Medical Center, 330 Brookline Ave, Boston, MA 02215. E-mail msimons{at}bidmc.harvard.edu
Background—Angiogenesis is a promising treatment strategy for patients who are not candidates for standard revascularization, because it promotes the growth of new blood vessels in ischemic myocardium.
Methods and Results—We conducted a randomized, double-blind, placebo-controlled study of basic fibroblast growth factor (bFGF; 10 or 100 µg versus placebo) delivered via sustained-release heparin-alginate microcapsules implanted in ischemic and viable but ungraftable myocardial territories in patients undergoing CABG. Twenty-four patients were randomized to 10 µg of bFGF (n=8), 100 µg of bFGF (n=8), or placebo (n=8), in addition to undergoing CABG. There were 2 operative deaths and 3 Q-wave myocardial infarctions. There were no treatment-related adverse events, and there was no rise in serum bFGF levels. Clinical follow-up was available for all patients (16.0±6.8 months). Three control patients had recurrent angina, 2 of whom required repeat revascularization. One patient in the 10-µg bFGF group had angina, whereas all patients in the 100-µg bFGF group remained angina-free. Stress nuclear perfusion imaging at baseline and 3 months after CABG showed a trend toward worsening of the defect size in the placebo group (20.7±3.7% to 23.8±5.7%, P=0.06), no significant change in the 10-µg bFGF group, and significant improvement in the 100-µg bFGF group (19.2±5.0% to 9.1±5.9%, P=0.01). Magnetic resonance assessment of the target ischemic zone in a subset of patients showed a trend toward a reduction in the target ischemic area in the 100-µg bFGF group (10.7±3.9% to 3.7±6.3%, P=0.06).
Conclusions—This study of bFGF in patients undergoing CABG demonstrates the safety and feasibility of this mode of therapy in patients with viable myocardium that cannot be adequately revascularized.
Key Words: heart diseases • angiogenesis • growth substances • myocardium
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