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Mechanisms of Efficacy: Safety Concerns and Early Results.

Coronary and peripheral atherosclerotic diseases affect more than 15 million patients in the United States alone. Over the last three decades significant progress has been made in the management of these patients using medical, surgical, and percutaneous therapies. However, there remains a significant population of patients who are not optimal candidates for surgical or percutaneous revascularization. These patients continue to suffer from the debilitating symptoms of their disease and remain at risk for myocardial events, limb loss, or death. It was this clinical need, coupled with the advances in the understanding of angiogenesis, that has led to efforts to develop angiogenic therapies for patients with peripheral and myocardial ischemia. In general, these conditions are characterized by local hypovascularity, and the approach to treatment is focused on stimulating neovascularization, ie, therapeutic angiogenesis.