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J Thorac Cardiovasc Surg 2002;124:28-34
© 2002 The American Association for Thoracic Surgery
Cardiopulmonary Support and Physiology (CSP) |
From the Departments of Surgery,a Medicine (Angiogenesis Research Center),b and Radiology,c Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Mass; and the Department of Medicine,d Albert Einstein College of Medicine, Bronx, NY.
This work was funded in part by National Institutes of Health grants HL-53793 and HL-56993 (Dr Simons), HL-46716 (Dr Sellke), HL-63609 (Dr Laham), and M01-RR0132 (Dr Laham). Dr Ruel is supported by research fellowship awards from the Heart and Stroke Foundation of Canada in partnership with the Canadian Institutes of Health Research.
Read at the Eighty-first Annual Meeting of The American Association for Thoracic Surgery, San Diego, Calif, May 6-9, 2001.
Received for publication May 15, 2001. Revisions requested Aug 22, 2001; revisions received Oct 10, 2001. Accepted for publication Nov 20, 2001. Address for reprints: Frank W. Sellke, MD, Division of Cardiothoracic Surgery, Beth Israel Deaconess Medical Center, 110 Francis St, Boston, MA 02215 (E-mail: fsellke{at}caregroup.harvard.edu).
Objective: The long-term effects of surgical fibroblast growth factor 2 therapy are examined.
Methods: In a randomized, double-blind study, fibroblast growth factor 2 (10 µg or 100 µg) or placebo (n = 8 each) was delivered in the ungraftable myocardial territory of patients concomitantly undergoing coronary artery bypass grafting. Patients were followed up to 32.2 ± 6.8 months postoperatively with clinical assessment and nuclear perfusion imaging.
Results: Baseline patient characteristics were similar between the 3 groups. There were 2 late deaths, one of pancreatic cancer and one of undetermined cause (both in the 100-µg fibroblast growth factor 2 group). Two patients (both in the control group) underwent a total of 6 repeat cardiac catheterizations for recurrent coronary events. Mean Canadian Cardiovawcular Society angina class improved at late follow-up from baseline in all groups (P 
.02); however, patients treated with either dose of fibroblast growth factor 2 had significantly more freedom from angina recurrence than those treated with placebo (P = .03). Late nuclear perfusion scans revealed a persistent reversible or a new, fixed perfusion defect in the ungraftable territory of 4 of 5 patients who received placebo versus only 1 of 9 patients treated with fibroblast growth factor 2 (P = .02). The overall sum of left ventricular stress perfusion defect scores was also lower in fibroblast growth factor 2-treated patients than in control subjects (1.3 ± 1.4 vs 3.9 ± 2.1, respectively; P = .04). A trend toward a higher late left ventricular ejection fraction was noted in fibroblast growth factor 2-treated patients (55.1% ± 14.6% vs 44.3% ± 6.5%, fibroblast growth factor 2-treated patients versus control subjects; P = .12).
Conclusions: These data suggest that surgical angiogenic therapy with sustained-release fibroblast growth factor 2 may result in a prolonged myocardial revascularization effect that could translate into clinical benefit.
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