CORAL: Economics and QOL Core Laboratory

描述(由申请人提供)： 健康相关性和长期目标：动脉粥样硬化性肾动脉狭窄是一个常见的问题，对其诊断或治疗还没有明确的共识。可能存在肾缺血导致神经内分泌激活、高血压和肾功能不全的进展，可能导致动脉粥样硬化的加速、进一步的肾功能障碍、心肌梗死、中风和死亡。目前的提案测试了狭窄肾动脉的血运重建加最佳药物治疗与单纯最佳药物治疗相比是否与改善临床结果相关。 具体目标、设计和方法：肾动脉粥样硬化性病变(COALL)的心血管结局是一项随机临床试验，它将在心血管和肾脏的复合终点：心血管或肾死亡、心肌梗死、因充血性心力衰竭住院、中风、血清肌酐水平翻倍以及需要肾脏替代疗法方面，对比最佳药物治疗和支架治疗的效果。这一终点将由一个临床事件委员会裁决，该委员会负责治疗分配。次要终点1)评估与临床事件有关的机制；2)描述关键末端器官的不同疗效；3)从患者和卫生政策的角度确定支架置入术的价值，以生活质量和成本效益衡量；以及4)评估主要终点内与临床相关的治疗效果差异。入选的主要标准是动脉粥样硬化性肾狭窄(<60%)、收缩压差为20 mm Hg、使用2种或2种以上抗高血压药物的收缩期高血压(<155 mm Hg)。预计妇女将略微占多数，并将高度优先考虑少数族裔的招聘。大约2200名患者将接受基线评估，随机分组将在1080年进行。这项研究有90%的能力检测到主要终点风险降低28%。这份来自经济学和生活质量核心实验室的R01描述了额外的数据收集和分析，旨在确定肾动脉支架植入术对健康相关生活质量的益处，以及肾动脉支架植入术的成本效益，其依据是每获得一年质量调整的生命年的标准度量成本。

DESCRIPTION (provided by applicant): Health-relatedness and Long-term Objectives: Atherosclerotic renal artery stenosis is a common problem for which there is no clear consensus on diagnosis or therapy. There likely exists a progression wherein renal ischemia leads to neuroendocdne activation, hypertension, and renal insufficiency potentially resulting in acceleration of therosclerosis, further renal dysfunction, myocardial infarction, stroke and death. The current proposal tests whether revascularization of a stenotic renal artery plus optimum medical therapy is associated with improved clinical outcomes when compared with optimum medical therapy alone. Specific Aims, Design and Methods: Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) is a randomized clinical trial that will contrast the effect of optimum medical therapy alone to stenting with optimum medical therapy, on a composite cardiovascular and renal endpoint: cardiovascular or renal death, myocardial infarction, hospitalization for congestive heart failure, stroke, doubling of serum creatinine level, and need for renal replacement therapy. This endpoint will be adjudicated by a clinical events committee masked to treatment assignment. The secondary endpoints 1) evaluate the mechanisms linked to clinical events; 2) describe differential effectiveness in critical end-organs; 3) determine the value of stenting from the patient and the health policy perspectives, measured as quality of life and cost effectiveness; and 4) evaluate for clinically relevant differences in treatment effectiveness within the primary endpoint. The primary entry criteria are an atherosclerotic renal stenosis >=60% with a 20 mmHg systolic pressure gradient and systolic hypertension >155 mmHg on 2 or more anti-hypertensive medications. A slight predominance of women is expected, and high priority will be placed on minority recruitment. Approximately 2200 patients will undergo a baseline evaluation with randomization occurring in 1080. The study has 90% power to detect a 28% reduction in primary endpoint hazard rate. This R01, from the economics and quality of life core laboratory, describes the additional data collection and analyses that are proposed to determine the benefits of renal artery stenting on health-related quality of life and the cost-effectiveness of renal artery stenting in terms of a standard metric-cost per quality-adjusted year of life gained.