EFFECT OF LIPID MODIFICATION ON PERIPHERAL ARTERIAL DISEASE AFTER ENDOVASCULA

这个子项目是许多利用资源的研究子项目之一 由NIH/NCRR资助的中心拨款提供。子项目的主要支持 而子项目的主要调查员可能是由其他来源提供的， 包括其它NIH来源。 列出的子项目总成本可能 代表子项目使用的中心基础设施的估计数量， 而不是由NCRR赠款提供给子项目或子项目工作人员的直接资金。 I.假设 本研究的假设如下：强化脂质修饰与联合治疗将通过减少血栓形成和炎症来抑制动脉粥样硬化的进展，并降低血管内支架植入术后股动脉再狭窄的发生率。 二.具体目标 总体而言，我们将招募120例单侧下肢有症状性股动脉闭塞性疾病的患者。 这些患者将接受血管内支架植入术治疗，然后随机分为两个治疗组：1）标准医疗护理，包括他汀类药物治疗;和2）标准医疗护理，使用他汀类药物+依折麦布和烟酸缓释剂强化调脂，以升高HDL（40）并降低LDL（80）和TG（150）。 具体而言，我们将对这些患者进行为期2年的随访，并研究以下具体目标： 1. 使用高分辨率MRI成像技术检查支架置入股动脉的支架内再狭窄和对侧股动脉的动脉粥样硬化进展，以确定强化脂质修饰治疗对动脉粥样硬化进展和股动脉再狭窄的影响。 2.通过双功超声、节段性肢体压力、节段性脉搏容积记录、踝肱指数、踏车行走距离、绝对跛行和 生活质量问卷。 3.确定强化脂质修饰治疗对脂蛋白、炎症的影响以及与PAD进展、再狭窄和临床事件的关系。 4.确定强化脂质修饰治疗对血栓形成的影响，以及与PAD进展、再狭窄和临床事件的关系。 将确定这些血液检查与临床结局和股动脉影像的相关性。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. I. HYPOTHESIS 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. II. SPECIFIC AIMS 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.