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 mug or 100 mug) 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-mug 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 less than or equal to .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 I 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.