Stent Placement in Patients With Atherosclerotic Renal Artery Stenosis and Impaired Renal Function A Randomized Trial
Stent Placement in Patients With Atherosclerotic Renal Artery Stenosis and Impaired Renal Function A Randomized Trial
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DOI：
10.7326/0003-4819-150-12-200906160-00119
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发表时间：
2009-06-16
影响因子：
39.2
通讯作者：
Beutler, Jaap J.
中科院分区：
文献类型：
--
作者：
Bax, Liesbeth;Woittiez, Arend-Jan J.;Beutler, Jaap J.
背景资料：肾动脉支架植入术治疗动脉粥样硬化性肾动脉狭窄（ARAS）合并肾功能损害的疗效和安全性目前尚不清楚，目的：探讨支架植入术治疗ARAS合并肾功能损害的疗效和安全性。随机化是集中的，由计算机生成，分配通过电子邮件进行。患者、医疗服务提供者和评估结果的人员对治疗分配不设盲。设置：10个欧洲医疗中心。参与者：140例肌酐清除率低于80 mL/min/1.73 m2且ARAS ≥ 50%的患者。干预：支架置入和药物治疗（64例患者）或仅药物治疗（76例患者）。药物治疗包括抗高血压治疗，他汀类药物和阿司匹林。测量：主要终点是肌酐清除率下降20%或以上。次要终点包括安全性以及心血管发病率和死亡率。结果：64名被分配植入支架的患者中有46名接受了手术。支架置入组64例患者中的10例（16%）和药物治疗组16例患者（22%）达到主要终点（风险比，0.73 [95%CI，0.33 - 1.61]）。支架组发生严重并发症，包括2例手术相关死亡（3%），1例继发于感染性血肿的晚期死亡，1例继发于胆固醇栓塞需要透析的患者。其他次要endpoints.Limitation：许多患者被错误地识别为肾动脉狭窄大于50%的非侵入性成像，并没有最终需要stenting.Conclusion：支架置入与药物治疗对肾功能损害的进展没有明确的影响，但导致了少数显着的程序相关并发症。研究结果支持对ARAS患者采取保守治疗方法，重点是心血管风险因素管理和避免支架植入。
Background: Little is known about the efficacy and safety of renal artery stenting in patients with atherosclerotic renal artery stenosis (ARAS) and impaired renal function.Objective: To determine the efficacy and safety of stent placement in patients with ARAS and impaired renal function.Design: Randomized clinical trial. Randomization was centralized and computer generated, and allocation was assigned by e-mail. Patients, providers, and persons who assessed outcomes were not blinded to treatment assignment.Setting: 10 European medical centers.Participants: 140 patients with creatinine clearance less than 80 mL/min per 1.73 m(2) and ARAS of 50% or greater.Intervention: Stent placement and medical treatment (64 patients) or medical treatment only (76 patients). Medical treatment consisted of antihypertensive treatment, a statin, and aspirin.Measurements: The primary end point was a 20% or greater decrease in creatinine clearance. Secondary end points included safety and cardiovascular morbidity and mortality.Results: Forty-six of 64 patients assigned to stent placement had the procedure. Ten of the 64 patients (16%) in the stent placement group and 16 patients (22%) in the medication group reached the primary end point (hazard ratio, 0.73 [95% CI, 0.33 to 1.61]). Serious complications occurred in the stent group, including 2 procedure-related deaths (3%), 1 late death secondary to an infected hematoma, and 1 patient who required dialysis secondary to cholesterol embolism. The groups did not differ for other secondary end points.Limitation: Many patients were falsely identified as having renal artery stenosis greater than 50% by noninvasive imaging and did not ultimately require stenting.Conclusion: Stent placement with medical treatment had no clear effect on progression of impaired renal function but led to a small number of significant procedure-related complications. The study findings favor a conservative approach to patients with ARAS, focused on cardiovascular risk factor management and avoiding stenting.