This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The hypothesis for the study is as follows: Intensive lipid modification with combination therapy will inhibit the progression of atherosclerosis and reduce the incidence of restenosis in femoral arteries following endovascular stenting by decreasing thrombosis and inflammation. In general, we will recruit a total of 120 patients with symptomatic femoral artery occlusive disease in one leg. These patients will be treated with endovascular stenting, and then randomized into two treatment groups: 1)standard of medical care including statin therapy;and 2) standard of medical care with intensive lipid modification using a statin plus ezetimibe and extended release niacin to increase HDL (>40) and decrease LDL (<80) and TG (<150). Specifically, we will follow these patients for 2 years and study the following specific aims: 1. To determine the effect of intensive lipid modification therapy on progression of atherosclerosis and restenosis of femoral arteries using high resolution MRI image technology to exam both the stented femoral artery for in-stent restenosis and the contralateral fermoral artery for progression of atherosclerosis. 2. To determine the effect of intensive lipid modification therapy on the clinically applicable hemodynamic measurements, clinical symptoms, reduction in systemic major cardiovascular events and the general quality of life of patients following PTA revascularization and stenting by assessment with Duplex ultrasound, segmental limb pressure, segmental pulse volume recording, ankle brachial indicies, treadmill walking distance, absolute claudication and quality of life questionnaires. 3. To determine the effect of intensive lipid modification therapy on lipoproteins, inflammation, and relationship to PAD progression, restenosis, and clinical events. 4. To determine the effect of intensive lipid modification therapy on thrombosis, and relationship to PAD progression, restenosis and clinical events. The association of these blood tests with clinical outcome and femoral artery image will be determined.
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