One trial was presented at the American College of Cardiology scientific session in March of 2003. This multinational study, however, involved only 80 patients. Patients with end-stage refractory angina with severe ischemic heart disease not amenable to all forms of revascularization therapy were randomized. Patients with recent myocardial infarction or proliferative retinopathy were excluded.
Direct myocardial injections of gene therapy with phVEGF-A165 (vascular growth factor) were tested. Ten myocardial injections of a plasmid solution was the therapy. After three months’ follow up using various tests there was an increase in blood flow and new vessels observed. Angina symptoms showed a modest improve¬ment. The improvement in myocardial perfusion observed needs further studies for confirmation. The investigators agreed that there was a large placebo effect. No major adverse effects were noted in the short-term study.
B. Study in Patients with Disabling Intermittent Claudication
Regional angiogenesis with vascular endothelial growth factor in peripheral arterial disease (RAVE) is a phase to randomized double-blind controlled trial in patients with disabling intermittent claudication. This well-conducted study showed no improvement in claudication and other parameters after 26 weeks of therapy. This is the largest such trial to date and follow up indicates no significant differences in treatment versus placebo.

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