肾动脉支架植入术对动脉粥样硬化性肾动脉狭窄的生活质量影响：CORAL随机试验的结果。

IF 4.8 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

European Heart Journal - Quality of Care and Clinical Outcomes Pub Date : 2024-10-14 DOI:10.1093/ehjqcco/qcae087

Suzanne V Arnold, Kaijun Wang, Ajay J Kirtane, Elizabeth A Magnuson, Khaja M Chinnakondepalli, Christopher J Cooper, Lance D Dworkin, David J Cohen

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引用次数: 0

摘要

背景：肾动脉狭窄可能与难以控制的高血压有关，但肾动脉支架植入术尚未证明能改善临床疗效。肾动脉支架置入术后，替代降压药物可能会提高生活质量：我们在 CORAL 试验--动脉粥样硬化性肾动脉狭窄患者肾动脉支架置入术与药物治疗的多中心、随机、开放标签试验--中进行了一项预先指定的生活质量子研究。我们采用纵向增长曲线模型来比较不同治疗组在一段时间内的身体症状压力指数（PSDI）、SF-36 和 EQ-5D 评分。我们还试图验证高血压研究中的生活质量评估方法：在 906 名患者（平均年龄为 69.2 ± 9.1 岁，49.7% 为男性）中，降压药物副作用引起的症状频率和痛苦随时间的推移变化很小，治疗组之间没有显著差异。在 SF-36 及其分量表或 EQ-5D 方面，治疗组之间也没有明显的临床差异。在生活质量测量的内部验证中，PSDI与抗高血压药物的数量/类型有很好的相关性，而一般健康状况测量与晚期临床事件有相关性：在一项大型、多中心、随机临床试验中，我们发现在治疗动脉粥样硬化性肾动脉狭窄时，就疾病特异性或一般生活质量指标而言，常规肾动脉支架植入术与药物治疗相比没有明显优势。由于这些生活质量指标对患者很重要，而且与用药依从性有关，因此未来的降压治疗研究应考虑将这些生活质量指标作为次要结果。试验注册：ClinicalTrials.gov：NCT00081731。

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Quality of Life Effects of Renal Artery Stenting Versus Medical Therapy for Atherosclerotic Renal-Artery Stenosis: Results from the Randomized CORAL Trial.

Background: Renal-artery stenosis can be associated with difficult to control hypertension, although renal-artery stenting has not been shown to improve clinical outcomes. Alternative antihypertensive medications could potentially result in quality of life benefits with renal-artery stenting.

Methods: We performed a pre-specified quality of life sub-study of the CORAL trial-multicenter, randomized, open-label trial of renal-artery stenting versus medical therapy in patients with atherosclerotic renal-artery stenosis. Longitudinal growth curve models were used to compare the Physical Symptoms Distress Index (PSDI), SF-36, and EQ-5D scores over time between treatment groups. We also sought to validate the approach of assessing quality of life in hypertension studies.

Results: Among 906 patients (mean age 69.2 ± 9.1years, 49.7% men), symptom frequency and distress due to side effects from antihypertensive medications changed minimally over time, with no significant differences between treatment groups. There were also no clinically significant differences between treatment groups for the SF-36 and its subscales or the EQ-5D. In internal validation of the quality of life measures, the PSDI correlated well with number/type of antihypertensive medications, and generic health status measures correlated with late clinical events.

Conclusions: In a large, multicenter, randomized clinical trial, we found no significant benefit of routine renal-artery stenting over medical management for the treatment of atherosclerotic renal-artery stenosis in terms of disease-specific or generic quality of life measures. As these quality of life measures are important to patients and are associated with medication compliance, future studies of antihypertensive treatments should consider including these quality of life measures as secondary outcomes. Trial registration: ClinicalTrials.gov: NCT00081731.

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来源期刊

European Heart Journal - Quality of Care and Clinical Outcomes CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

9.40

自引率

3.80%

发文量

期刊介绍： European Heart Journal - Quality of Care & Clinical Outcomes is an English language, peer-reviewed journal dedicated to publishing cardiovascular outcomes research. It serves as an official journal of the European Society of Cardiology and maintains a close alliance with the European Heart Health Institute. The journal disseminates original research and topical reviews contributed by health scientists globally, with a focus on the quality of care and its impact on cardiovascular outcomes at the hospital, national, and international levels. It provides a platform for presenting the most outstanding cardiovascular outcomes research to influence cardiovascular public health policy on a global scale. Additionally, the journal aims to motivate young investigators and foster the growth of the outcomes research community.