Background: Gene therapy is a new, experimental method of treatment in patients with coronary artery disease (CAD).
Aim: To determine the safety and efficacy of gene encoding vascular endothelial growth factor (VEGF165) administered directly into the myocardium as the single treatment or combined with coronary artery by-pass grafting (CABG).
Methods: VEGF gene transfer was performed in 22 patients (20 male, 2 female, ages from 48 to 73 years old). A 200 micro g of the plasmid encoding VEGF165 was injected into the ischaemic myocardium which could not be surgically revascularised in patients undergoing CABG (n=14), and 400 micro g - in patients without CABG (n=8). The value of ejection fraction (EF), myocardial perfusion, angiogram, ventriculography, and nitroglycerine consumption as well as quality of life were evaluated pre- and postoperatively.
Results: The majority of patients had no complications and no fatal outcome was observed. Two patients developed acute myocardial infarction. Left ventricular function values improved and the majority of patients were free from angina 6 months after surgery. Patients reported improved quality of life and a reduction in nitroglycerine usage. A reduction in the ischaemic defects detected by SPECT was also observed. In some patients angiography revealed improved collateral filling.
Conclusions: Direct myocardial administration of genes encoding VEGF165 can be an effective method of treatment in patients with chronic and advanced CAD either as a supplementary treatment or as a single therapy.