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安进公司Endeavor Resolute®支架在多支血管病变患者中的安全性和有效性:HEART(湖南安进Endeavor Resolute)前瞻性多中心试验。

Safety and Efficacy of the Endeavor Resolute® Stent in Patients with Multivessel Disease: The HEART (Honam EndeAvor ResoluTe) Prospective, Multicenter Trial.

作者信息

Sim Doo Sun, Jeong Myung Ho, Hong Young Joon, Kim Ju Han, Ahn Youngkeun, Park Keun Ho, Hwang Sun Ho, Kang Dong Goo, Lee Seung Uk, Kim Joon Woo, Park Jong Pil, Rhew Jay Young, Lee Sang Rok, Chae Jei Keon, Yun Kyeong Ho, Oh Seok Kyu, Kang Won You, Kim Su Hyun, Cho Jang Hyun

机构信息

Department of Cardiovascular Medicine, Chonnam National University Hospital, Gwangju, Korea.

Department of Cardiology, Chosun University Hospital, Gwangju, Korea.

出版信息

Chonnam Med J. 2018 Jan;54(1):55-62. doi: 10.4068/cmj.2018.54.1.55. Epub 2018 Jan 25.

Abstract

The Endeavor Resolute® (ER) is a zotarolimus-eluting stent (ZES) with a biocompatible BioLinx polymer. This study prospectively compared the clinical outcomes of 2 versions of ZES, ER and Endeavor Sprint® (ES), in patients with multivessel disease. A total of 488 patients who underwent multivessel percutaneous coronary intervention (PCI) were divided into 2 groups the ER group (n=288) and the ES group (n=200). The primary endpoint was a composite of major adverse cardiac events (MACE) consisting of death, myocardial infarction, and target vessel revascularization after 12 months. In all patients, the prevalence of diabetes was higher in the ER group (42.7% vs. 31.0%, p=0.009). The rate of post-PCI Thrombolysis in Myocardial Infarction flow grade 3 was higher in the ER group (100.0% vs. 98.0%, p=0.028). There were no between-group differences in the in-hospital, 1-month and 12-month clinical outcomes. In the propensity score matched cohort (n=200 in each group), no differences were observed in the baseline and procedural characteristics. There were no statistical differences in the rates of in-hospital, 1-month and 12-month events (12-month MACE in the ER and ES groups: 6.0% vs. 3.5%, p=0.240, respectively). The safety and efficacy of both versions of ZES were comparable in patients with multivessel disease during a 12-month clinical follow-up.

摘要

安珂卓效(Endeavor Resolute®,ER)是一款带有生物相容性BioLinx聚合物的佐他莫司洗脱支架(ZES)。本研究前瞻性地比较了两种ZES(ER和安珂速进(Endeavor Sprint®,ES))在多支血管病变患者中的临床结局。共有488例行多支血管经皮冠状动脉介入治疗(PCI)的患者被分为两组,即ER组(n = 288)和ES组(n = 200)。主要终点是12个月后由死亡、心肌梗死和靶血管血运重建组成的主要不良心脏事件(MACE)复合终点。在所有患者中,ER组的糖尿病患病率更高(42.7%对31.0%,p = 0.009)。ER组PCI术后心肌梗死溶栓血流3级的比例更高(100.0%对98.0%,p = 0.028)。住院期间、1个月和12个月的临床结局在两组之间无差异。在倾向评分匹配队列中(每组n = 200),基线和手术特征方面未观察到差异。住院期间、1个月和12个月事件发生率无统计学差异(ER组和ES组12个月MACE分别为6.0%对3.5%,p = 0.240)。在12个月的临床随访期间,两种ZES在多支血管病变患者中的安全性和有效性相当。

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