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Genous™ 生物工程 R 支架™ 冠状动脉支架置入术后的临床结果:全球 e-HEALING(健康内皮加速内膜抑制新生内膜生长)注册研究的 12 个月结果。

Clinical results after coronary stenting with the Genous™ Bio-engineered R stent™: 12-month outcomes of the e-HEALING (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth) worldwide registry.

机构信息

Kardiologische Praxis und Praxisklinik, Munich, Germany.

出版信息

EuroIntervention. 2011 Feb;6(7):819-25. doi: 10.4244/EIJV6I7A141.

DOI:10.4244/EIJV6I7A141
PMID:21252015
Abstract

AIMS

e-HEALING is a worldwide, internet-based registry designed to capture post marketing clinical data on the use of the Genous™ EPC capturing R stent™. Rapid restoration of a healthy endothelial layer after stent placement by capturing circulating endothelial progenitor cells may reduce both stent thrombosis (ST) and in-stent-restenosis.

METHODS AND RESULTS

We planned a 5,000 patient registry with ≥1 lesion suitable for stenting. The 12-month primary outcome was target vessel failure (TVF), defined as target vessel-related cardiac death or myocardial infarction (MI) and target vessel revascularisation. Secondary outcomes were the composite of cardiac death, MI or target lesion revascularisation (TLR), and individual outcomes including ST. A total of 4,939 patients received ≥1 Genous stent between 2005 and 2007. Baseline characteristics showed a median age of 63 years, 79% males, 25% diabetics, and 37% with prior MI. A total of 49% of lesions treated were ACC/AHA type B2 or C; 1.1 stents per lesion were used. At 12 months, TVF occurred in 8.4% and the composite of cardiac death, MI or TLR in 7.9%. Twelve-month TLR and ST were 5.7% and 1.1%, respectively.

CONCLUSIONS

Coronary stenting with the Genous results in good clinical outcomes, and low incidences of repeat revascularisation and ST.

摘要

目的

e-HEALING 是一个全球性的基于互联网的注册系统,旨在收集 Genous™ EPC 捕获 R 支架™ 上市后临床使用的数据。支架置入后通过捕获循环内皮祖细胞快速恢复健康的内皮层,可能会降低支架血栓形成(ST)和支架内再狭窄的风险。

方法和结果

我们计划开展一个 5000 例患者的注册研究,每个患者至少有 1 个适合支架置入的病变。12 个月的主要终点是靶血管失败(TVF),定义为靶血管相关的心脏死亡、心肌梗死(MI)和靶血管血运重建。次要终点是心脏死亡、MI 或靶病变血运重建(TLR)的复合终点,以及包括 ST 的单个终点。2005 年至 2007 年间,共有 4939 例患者接受了至少 1 枚 Genous 支架。基线特征显示,中位年龄为 63 岁,79%为男性,25%为糖尿病患者,37%有既往 MI。接受治疗的病变中,49%为 ACC/AHA 类型 B2 或 C;每例病变平均使用 1.1 枚支架。12 个月时,TVF 发生率为 8.4%,心脏死亡、MI 或 TLR 的复合终点发生率为 7.9%。12 个月时 TLR 和 ST 的发生率分别为 5.7%和 1.1%。

结论

冠状动脉支架置入术采用 Genous 支架可获得良好的临床结果,且再血管化和 ST 的发生率较低。

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