The Efficacy of Therapeutic Angiogenesis Using basic Fibroblast Growth Factor in Patients with Coronary Artery Disease: A Double-Blind, Placebo-Controlled Study

Background and Objectives: Complete revascularization is not possible in up to 37% of patients with coronary artery disease (CAD). Therapeutic angiogenesis may be considered as an option in the management of these patients. The aim of the present study was to evaluate the effectiveness and safety of therapeutic angiogenesis using basic fibroblast growth factor in patients with CAD.   Methods: In this double-blind, placebo-controlled study, eighteen patients with a severe diffuse atherosclerotic disease along the left anterior descending (LAD) artery who were a CABG candidate with at least one graftable coronary artery and the presence of ischemia and viable areas along the LAD were enrolled. The patients were randomized into two groups to either undergo CABG and simultaneous FGF-2 therapy (bFGF group) or CABG without FGF-2 therapy (control group). During the CABG procedure in bFGF group, FGF-2/alginate-heparin-sepharose microcapsules, each contains 100 mcg FGF-2, were implanted in the subepicardial layer of the diffusely defective LAD territory via 2-3 mm stab incisions. Seven patients in each group were followed up for a period of 24 months.    Findings: The result of left ventricular evaluation with echocardiography and perfusion scans showed significant improvement in FGF-2-receiving group with no significant change in controls, 3 and 6 months after the intervention. New Yor; Heart Association (NYHA) class was significantly lower in the intervention group (1.43±0.535 vs. 2.57±.535, P = 0.002), In addition, intervention group remained free of angina 24 months after the intervention while three patients in the control group were hospitalized due to the acute chest pain.   Conclusions: Our study revealed that FGF-2 can improve the outcomes of patients with CAD undergoing CABG, without serious adverse effects. Considering other advantages associated with protein therapy our finding may help open novel avenues to safe and cost-effective therapy of the target patients.