Insights from angiogenesis trials using fibroblast growth factor for advanced arteriosclerotic disease.

The aim of therapeutic angiogenesis in cardiovascular disease states is to improve myocardial and peripheral extremity perfusion and function within ischemic regions that are not amenable to traditional modes of revascularization. Substantial "proof of concept," efficacy, and safety data have emerged from numerous animal models and clinical trials that fibroblast growth factor (FGF), when administered by various delivery strategies, has a therapeutic angiogenic capacity. This initial excitement has been replaced by cautious optimism in the wake of results from larger, randomized, double-blinded placebo-controlled trials of both FGF gene and protein administration. A greater understanding of the profound placebo effect, careful patient selection, and improved endpoint assessment are factors that need to be addressed in this rapidly evolving era of molecular therapeutics.