ASTRAL试验中动脉粥样硬化性肾血管疾病肾血管重建术后的长期疗效。

IF 6.1 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
Hannah O'Keeffe, Darren Green, Aine de Bhailis, Rajkumar Chinnadurai, Keith Wheatley, Jonathan Moss, Philip A Kalra
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引用次数: 0

摘要

背景:ASTRAL试验(肾动脉病变血管成形术和支架植入术)在2000年至2007年间招募了806名患者。患有动脉粥样硬化性肾动脉狭窄(RAS)且临床医生不确定血管重建是否有益的患者被按1:1的比例随机分配接受药物治疗或不接受肾动脉支架植入术。初步结果于 2009 年公布,中位随访 33.6 个月,结果显示血管重建对肾脏或心血管预后没有益处。存活患者的随访一直持续到 2013 年底,本研究介绍了长期随访结果:对数据进行了分析,以评估血管再通术后是否会对肾功能、心血管事件和存活率产生影响,包括肾功能、心血管结果和死亡的综合结果(与CORAL试验[肾动脉粥样硬化病变的心血管结果]相同)。预设的亚组分析包括不同类别的肾功能、肾功能的快速恶化以及 RAS 的程度。对严重RAS(双侧70%或单侧肾脏>70%)患者、有或无蛋白尿患者进行了事后分析,并进行了按协议分析:入组患者的平均年龄为 70.5 岁,平均肾小球滤过率为 40 mL/min/1.73 m2,平均 RAS 为 76%,平均血压为 150/76 mm Hg;血管重建组中 83% 的患者尝试了支架植入术。中位随访时间为 56.4 个月,108 名患者失去了随访机会。随访结束时,50%的可评估患者死亡,18%首次发生肾脏事件,40%首次发生心血管事件。在意向治疗分析和按协议分析中,没有观察到任何结果存在统计学差异:ASTRAL试验的长期随访结果显示,肾血管重建对肾脏和心血管预后没有总体益处。该研究强调,部分人群的RAS风险较低,因此在高风险人群中开展进一步研究可能有其价值:URL: https://www.isrctn.com; Unique identifier:ISRCTN59586944。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Long Term Outcomes After Renal Revascularization for Atherosclerotic Renovascular Disease in the ASTRAL Trial.

Background: The ASTRAL trial (Angioplasty and Stenting for Renal Artery Lesions) recruited 806 patients between 2000 and 2007. Patients with atherosclerotic renal artery stenosis (RAS) and clinician uncertainty about the benefit of revascularization were randomized 1:1 to medical therapy with or without renal artery stenting. The initial results were presented in 2009 at a median 33.6-month follow-up, with no benefit of revascularization on renal or cardiovascular outcomes. Surviving patients remained under follow-up until the end of 2013, and the long-term results are presented in this study.

Methods: Data were analyzed to assess whether there was a later impact of revascularization on renal function, cardiovascular events, and survival, including a composite outcome of renal and cardiovascular outcomes and death (as in the CORAL trial [Cardiovascular Outcomes in Renal Atherosclerotic Lesions]). Prespecified subgroup analyses included different categories of renal function, rapid deterioration in kidney function, and degree of RAS. Post hoc analyses of patients with severe RAS (bilateral 70% or >70% in a solitary kidney), those with or without proteinuria, and a per-protocol analysis were performed.

Results: The mean age of the entry population was 70.5 years, the mean estimated glomerular filtration rate was 40 mL/min/1.73 m2, the mean RAS was 76%, and the mean blood pressure was 150/76 mm Hg; 83% of the revascularization group underwent attempted stenting. The median follow-up was 56.4 months, with 108 patients lost to follow-up. By the end of follow-up, 50% of the evaluable population had died, 18% had suffered a first renal event, and 40% had suffered a first cardiovascular event. No statistical difference was observed for any outcome in the intention-to-treat and per-protocol analyses.

Conclusions: The long-term follow-up of the ASTRAL trial showed no overall benefit of renal revascularization to renal and cardiovascular outcomes. It has been highlighted that a proportion of the population had lower-risk RAS, and there is likely to be merit in further study in a higher-risk population.

Registration: URL: https://www.isrctn.com; Unique identifier: ISRCTN59586944.

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来源期刊
Circulation: Cardiovascular Interventions
Circulation: Cardiovascular Interventions CARDIAC & CARDIOVASCULAR SYSTEMS-
CiteScore
10.30
自引率
1.80%
发文量
221
审稿时长
6-12 weeks
期刊介绍: Circulation: Cardiovascular Interventions, an American Heart Association journal, focuses on interventional techniques pertaining to coronary artery disease, structural heart disease, and vascular disease, with priority placed on original research and on randomized trials and large registry studies. In addition, pharmacological, diagnostic, and pathophysiological aspects of interventional cardiology are given special attention in this online-only journal.
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