Long-term effects of surgical angiogenic therapy with fibroblast growth factor 2 protein.
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 microg or 100 microg) 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-microg 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 Cardiovascular Society angina class improved at late follow-up from baseline in all groups (P < or = .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.
Ruel
Marc
M
Department of Surgery, Medicine, Angiogenesis Research Center, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA 02215, USA.
Laham
Roger J
RJ
Parker
J Anthony
JA
Post
Mark J
MJ
Ware
J Anthony
JA
Simons
Michael
M
Sellke
Frank W
FW
D001026:Coronary Artery Bypass; D004311:Double-Blind Method; D005260:Female; D016222:Fibroblast Growth Factor 2 / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006321:Heart / Q000000981:diagnostic imaging; D006801:Humans; D008297:Male; D008875:Middle Aged; D017256:Technetium Tc 99m Sestamibi; D013794:Thallium Radioisotopes; D013997:Time Factors; D015899:Tomography, Emission-Computed, Single-Photon
D013794:Thallium Radioisotopes; D016222:Fibroblast Growth Factor 2; D017256:Technetium Tc 99m Sestamibi