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种常见的疾病，目前对其诊断或治疗尚无明确的共识。可能存在一种进展，其中肾缺血导致神经内分泌激活、高血压和肾功能不全，可能导致治疗加速、进一步肾功能不全、心肌梗死、中风和死亡。目前的建议测试狭窄肾动脉血运重建加最佳药物治疗是否与改善的临床结果相比，最佳的药物治疗。 特定目的、设计和方法：肾动脉粥样硬化病变的心血管结局（CORAL）是一项随机临床试验，将比较单独最佳药物治疗与支架植入联合最佳药物治疗对心血管和肾脏复合终点的影响：心血管或肾脏死亡、心肌梗死、充血性心力衰竭住院、中风、血清肌酐水平加倍，需要肾脏替代治疗该终点将由对治疗分配设盲的临床事件委员会裁定。次要终点1）评价与临床事件相关的机制; 2）描述关键终末器官的差异有效性; 3）从患者和卫生政策角度确定支架植入术的价值，衡量为生活质量和成本效益; 4）评价主要终点内治疗有效性的临床相关差异。主要入选标准为动脉粥样硬化性肾狭窄≥ 60%，收缩压梯度20 mmHg，使用2种或2种以上抗高血压药物时收缩期高血压>155 mmHg。预计妇女略占优势，将高度优先考虑征聘少数族裔。约2200例患者将接受基线评价，其中1080例患者随机分组。该研究有90%的把握度检测到主要终点风险率降低28%。本R 01来自经济学和生活质量核心实验室，描述了拟定用于确定肾动脉支架植入术对健康相关生活质量的受益以及肾动脉支架植入术的成本-效果（根据获得的每质量调整生命年的标准度量成本）的额外数据收集和分析。

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.