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药物洗脱支架时代薄支架钴铬合金支架的长期临床结果:COBALT(所有患者病变治疗中裸金属支架比较)注册研究的结果。

Long-term clinical outcome of thin-strut cobalt-chromium stents in the drug-eluting stent era: results of the COBALT (comparison of bare-metal stents in all-comers' lesion treatment) registry.

机构信息

Heart Center, Segeberger Kliniken GmbH (Academic Teaching Hospital of the University of Kiel), Bad Segeberg, Germany.

出版信息

J Interv Cardiol. 2011 Dec;24(6):496-504. doi: 10.1111/j.1540-8183.2011.00672.x. Epub 2011 Oct 10.

Abstract

BACKGROUND

Despite widespread penetration of drug-eluting stents (DES) in clinical practice, a relevant percentage of patients with coronary artery disease are still treated with bare-metal stents (BMS). Contemporary BMS, however, are less well investigated and comparative data on clinical outcome are lacking.

METHODS AND RESULTS

This single-center registry aimed to assess characteristics and outcome of patients treated with 2 different new-generation cobalt-chromium BMS, the MULTI-LINK VISION and PRO-Kinetic stents. During the study, adopted criteria for BMS selection were: (1) limited compliance to dual antiplatelet therapy, (2) ST-elevation myocardial infarction (MI) or saphenous vein graft (SVG) interventions, and (3) noncomplex lesions located either in the right coronary artery or in the nonproximal segments of the left coronary artery. During a 24-month period 1,176 patients were treated with the VISION (n = 438) or PRO-Kinetic stent (n = 738). Median duration of follow-up was 549.5 and 528.5 days, respectively. Target lesion revascularization (TLR) and target vessel revascularization were numerically lower in the VISION group (10.4 vs. 12.3% and 11.9 vs. 15.2%, P = 0.24 and 0.11). Death (4.1 vs. 4.3%, P = 0.85), MI (2 vs. 2.3%, P = 0.78), and ARC definite stent thrombosis (0.5 vs. 0.5%, P = 0.84) were similar. By multivariate analysis, variables associated with TLR were SVG interventions (HR 2.21, 95% CI 1.26-3.86), total stent length (HR 1.01, 95% CI 1.00-1.02), and smoking (HR 1.51, 95% CI 1.05-2.16).

CONCLUSION

In the DES era, the use of last-generation thin-strut BMS in selected patients is associated with acceptable clinical outcome, with similar clinical results for both the MULTI-LINK VISION and PRO-Kinetic stents.

摘要

背景

尽管药物洗脱支架(DES)在临床实践中广泛应用,但仍有相当一部分冠心病患者接受金属裸支架(BMS)治疗。然而,目前对新一代钴铬 BMS 的研究较少,缺乏关于临床结果的比较数据。

方法和结果

本单中心注册研究旨在评估两种不同的新一代钴铬 BMS,即 MULTI-LINK VISION 和 PRO-Kinetic 支架治疗患者的特征和结局。在研究期间,采用 BMS 选择的标准为:(1)对双联抗血小板治疗的依从性有限,(2)ST 段抬高型心肌梗死(MI)或大隐静脉桥(SVG)介入,以及(3)非复杂病变位于右冠状动脉或左冠状动脉的非近端节段。在 24 个月的时间内,1176 例患者接受了 VISION 支架(n = 438)或 PRO-Kinetic 支架(n = 738)治疗。中位随访时间分别为 549.5 和 528.5 天。VISION 组的靶病变血运重建(TLR)和靶血管血运重建的发生率较低(10.4%比 12.3%和 11.9%比 15.2%,P = 0.24 和 0.11)。死亡率(4.1%比 4.3%,P = 0.85)、MI(2%比 2.3%,P = 0.78)和 ARC 明确支架血栓形成(0.5%比 0.5%,P = 0.84)相似。多变量分析显示,与 TLR 相关的变量包括 SVG 介入(HR 2.21,95%CI 1.26-3.86)、总支架长度(HR 1.01,95%CI 1.00-1.02)和吸烟(HR 1.51,95%CI 1.05-2.16)。

结论

在 DES 时代,在选定的患者中使用最新一代的薄壁 BMS 可获得可接受的临床结果,MULTI-LINK VISION 和 PRO-Kinetic 支架的临床结果相似。

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