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Intramyocardial Injection of Genes with a Novel Percutaneous Technique: Initial Safety Data of the Euroinject One Study

Therapeutic angiogenesis with vascular endothelial growth factor proteins or genes encoding for the proteins is a new potential treatment for patients who cannot be treated with conventional coronary bypass surgery or balloon angioplasty. The Euroinject One study is a multicenter noncommercial randomized double-blind placebo-controlled study of the therapy with the gene encoding for VEGF-A165. The study is designed to include 80 patients with severe coronary artery disease and a reversible defect on myocardial stress scintigraphy. It is planned that 40 patients will receive the VEGF-A165 plasmid and 40 patients the placebo plasmid without the gene encoding for VEGF-A165. The injection catheter is entered percutaneously into the left ventricle. Guided by electromechanical mapping with a NOGA system 10 intramyocardial injections of plasmid are given around and within the tissue area with reversible ischemia. The injections are monitored carefully regarding predefined variables to ensure injections of the genes into the ischemic myocardium. The primary endpoint are changes of reversible myocardial ischemia on stress myocardial scintigraphy. The safety data from the first 10 patients demonstrated that the percutaneous intracardial injection of genes seems safe and can be performed without complications.