Department of Cardiovascular Sciences, European Hospital, Rome, Italy (F.T., L.D.L., A.P., A.S.G., L.W.); Division of Cardiology of the Department of Medicine, University of Verona, Verona, Italy (F.R., M.P., C.V.); Institute of Cardiology, University Magna Grecia, Catanzaro, Italy (C.S.); Department of Cardiology, Vannini Hospital, Rome, Italy (I.P.); Institute of Cardiology, Cattolica University, Rome, Italy (C.T.); and Division of Nuclear Medicine, Madonna della Fiducia Clinic, Rome, Italy (F.N.).
Circulation. 2014 Mar 11;129(10):1104-12. doi: 10.1161/CIRCULATIONAHA.113.005186. Epub 2013 Dec 19.
Percutaneous coronary interventions in patients with chronic kidney disease have shown suboptimal results. Drug-eluting stents (DES) might reduce the rate of target vessel revascularization in comparison with bare-metal stents (BMS) in patients with chronic kidney disease. However, given the multiple concomitant individual variables present in such patients, the comparison of neointimal growth after percutaneous coronary intervention is complex and difficult to assess.
Randomized Comparison of Xience V and Multi-Link Vision Coronary Stents in the Same Multivessel Patient with Chronic Kidney Disease (RENAL-DES) was a prospective, randomized, multicenter study to directly compare the efficacy in the prevention of clinical restenosis of everolimus-eluting stent (Xience V) and BMS with an identical design (Multi-Link Vision), both implanted in the same patient with multivessel coronary artery disease and chronic kidney disease (estimated glomerular filtration rate <60 mL/min). The primary end point of the study was the ischemia-driven target vessel revascularization as detected with myocardial scintigraphy at 12 months. In 215 patients, 512 coronary vessels were successfully treated with the randomly assigned DES (n=257) or BMS (n=255). At 1 year, the rate of ischemia-driven target vessel revascularization for DES and BMS groups was 2.7% (95% confidence interval, 1.1%-5.6%) and 11.4% (95% confidence interval, 7.8% to 16%), respectively, P<0.001. For the multivariate analysis, independent predictors of the ischemia-driven target vessel revascularization were BMS implantation (odds ratio, 4.95; 95% confidence interval, 2.1-11.6; P<0.001) and vessel size (odds ratio, 0.32; 95% confidence interval, 0.1-0.7; P=0.006).
This is the first randomized trial showing a reduction of clinical restenosis with a new-generation DES in comparison with a BMS of equal design, in patients who have chronic kidney disease with multivessel coronary artery disease.
http://clinicaltrials.gov. Unique identifier: NCT00818792.
慢性肾脏病患者的经皮冠状动脉介入治疗效果并不理想。与金属裸支架（BMS）相比，药物洗脱支架（DES）可能会降低慢性肾脏病患者的靶血管血运重建率。然而，由于此类患者存在多种并存的个体变量，因此经皮冠状动脉介入治疗后新生内膜生长的比较非常复杂，难以评估。
随机比较慢性肾脏病多血管病变患者中使用依维莫司洗脱支架（Xience V）和多链接 Vision 冠状动脉支架的效果（RENAL-DES）是一项前瞻性、随机、多中心研究，旨在直接比较依维莫司洗脱支架（Xience V）和 BMS 的疗效，预防临床再狭窄，这两种支架设计相同（多链接 Vision），均植入多血管病变和慢性肾脏病（估算肾小球滤过率<60 mL/min）的同一患者。研究的主要终点是 12 个月时心肌闪烁成像检测到的缺血驱动的靶血管血运重建。在 215 例患者中，512 个冠状动脉血管成功接受了随机分配的 DES（n=257）或 BMS（n=255）治疗。1 年后，DES 和 BMS 组缺血驱动的靶血管血运重建率分别为 2.7%（95%置信区间，1.1%-5.6%）和 11.4%（95%置信区间，7.8%-16%），P<0.001。多变量分析显示，缺血驱动的靶血管血运重建的独立预测因素为 BMS 植入（比值比，4.95；95%置信区间，2.1-11.6；P<0.001）和血管大小（比值比，0.32；95%置信区间，0.1-0.7；P=0.006）。
这是第一项随机试验，表明与设计相同的 BMS 相比，新一代 DES 可降低慢性肾脏病多血管病变患者的临床再狭窄率。
