ABSTRACT

One approach to achieving therapeutic angiogenesis in the myocardium also deserves mention with regard to the applicability of FGF-2 treatment. An interesting double-blind, placebo-controlled, randomized clinical trial tested the safety and efficacy of a sustained-release FGF-2 formulation (heparin alginate microspheres) delivered at the time of coronary artery bypass surgery to regions of ‘‘viable’’ myocardium where the coronary artery vessels were too small for arterial bypass grafting. A small number of patients were assigned in a 1:1:1 ratio to receive placebo, or 10 or 100 mg of FGF-2 pellets. The study focused on nuclear perfusion imaging, and patients treated with 100 mg of FGF-2 reportedly had less angina and a significant reduction in stress perfusion defects (19 vs. 9.1%, P< 0.01) at 3 months compared to the other groups (51). The long-term effects of FGF-2 persisted through 32.26.8 months of follow-up (52). While this specific approach of pharmacologic administration is not well suited for large-scale clinical trials that will be necessary for approval of the drug by regulatory agencies, these findings support the concept of therapeutic angiogenesis in a placebo-controlled trial and the findings highlight the potential utility of prolonged exposure of a growth factor.