Stenting and medical therapy for atherosclerotic renal-artery stenosis.
Stenting and medical therapy for atherosclerotic renal-artery stenosis.
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DOI：
10.1056/nejmoa1310753
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发表时间：
2014-01-02
期刊：
影响因子：
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通讯作者：
CORAL Investigators
中科院分区：
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作者：
Cooper CJ;Murphy TP;Cutlip DE;Jamerson K;Henrich W;Reid DM;Cohen DJ;Matsumoto AH;Steffes M;Jaff MR;Prince MR;Lewis EF;Tuttle KR;Shapiro JI;Rundback JH;Massaro JM;D'Agostino RB Sr;Dworkin LD;CORAL Investigators
动脉粥样硬化性肾动脉狭窄是老年人的常见问题。尽管两项随机试验没有显示肾动脉支架置入术对肾功能的益处，但支架置入术在预防主要的肾脏和心血管不良事件方面的有效性尚不确定。我们随机将947名有动脉粥样硬化性肾动脉狭窄且在服用两种或两种以上降压药或慢性肾脏疾病的同时患有收缩期高血压的受试者分为药物治疗加肾动脉支架植入组和单纯药物治疗组。对参与者的心血管和肾脏不良事件(心血管或肾脏原因、心肌梗死、中风、因充血性心力衰竭住院、进行性肾功能不全或需要肾脏替代治疗的复合终点)的发生情况进行跟踪。在43个月的中位随访期(四分位数范围，31至55)中，在接受药物治疗的同时接受支架植入的参与者与仅接受药物治疗的参与者之间，主要复合终点的比率没有显著差异(分别为351%和35.8%；支架置入的风险比为0.94；95%可信区间[CI]为0.76至1.17；P=0.58)。治疗组之间在主要终点的各个组成部分的比率或全因死亡率方面也没有显著差异。在随访期间，支架组的收缩压有一致的轻微差异(−2.3 mm Hg；95%CI，−4.4至−0.2；P=0.0 3)。在动脉粥样硬化性肾动脉狭窄、高血压或慢性肾脏疾病患者的综合、多因素药物治疗中，肾动脉支架置入术在预防临床事件方面没有显著益处。(由国家心肺血液研究所等资助；ClinicalTrials.gov编号，NCT00081731。)
Atherosclerotic renal-artery stenosis is a common problem in the elderly. Despite two randomized trials that did not show a benefit of renal-artery stenting with respect to kidney function, the usefulness of stenting for the prevention of major adverse renal and cardiovascular events is uncertain. We randomly assigned 947 participants who had atherosclerotic renal-artery stenosis and either systolic hypertension while taking two or more antihypertensive drugs or chronic kidney disease to medical therapy plus renal-artery stenting or medical therapy alone. Participants were followed for the occurrence of adverse cardiovascular and renal events (a composite end point of death from cardiovascular or renal causes, myocar-dial infarction, stroke, hospitalization for congestive heart failure, progressive renal insufficiency, or the need for renal-replacement therapy). Over a median follow-up period of 43 months (interquartile range, 31 to 55), the rate of the primary composite end point did not differ significantly between participants who underwent stenting in addition to receiving medical therapy and those who received medical therapy alone (35.1% and 35.8%, respectively; hazard ratio with stenting, 0.94; 95% confidence interval [CI], 0.76 to 1.17; P = 0.58). There were also no significant differences between the treatment groups in the rates of the individual components of the primary end point or in all-cause mortality. During follow-up, there was a consistent modest difference in systolic blood pressure favoring the stent group (−2.3 mm Hg; 95% CI, −4.4 to −0.2; P = 0.03). Renal-artery stenting did not confer a significant benefit with respect to the prevention of clinical events when added to comprehensive, multifactorial medical therapy in people with atherosclerotic renal-artery stenosis and hypertension or chronic kidney disease. (Funded by the National Heart, Lung and Blood Institute and others; ClinicalTrials.gov number, NCT00081731.)