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非聚合型紫杉醇洗脱微孔支架在真实世界经皮冠状动脉介入治疗中的安全性和有效性

Safety and efficacy of a non-polymeric paclitaxel-eluting microporous stent in real-world percutaneous coronary intervention.

作者信息

Wang Shao-Peng, Huang Rong-Chong, Zhu Hao, Zhang Bo, Zheng Zhen-Guo, Yin DA, Wang Jun-Jie, Zhou Xu-Chen

机构信息

Department of Cardiology, First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning 116011, P.R. China.

出版信息

Exp Ther Med. 2013 Sep;6(3):811-815. doi: 10.3892/etm.2013.1217. Epub 2013 Jul 11.

Abstract

At present, there is an increasing focus on stents that have a biodegradable polymer coating, rather than a permanent polymer coating. This is due to the fact that following the implantation of a drug-eluting stent (DES) with a permanent polymer coating, the continued existence of the coating may result in a foreign body reaction and delayed re-endothelialization. The aim of the present study was to evaluate the safety and efficacy of a non-polymeric paclitaxel-eluting microporous (YINYI™) stent in real-life percutaneous coronary intervention (PCI) for patients with coronary artery disease (CAD). A total of 686 YINYI™ stents were implanted in 404 patients with CAD in a PCI procedure and outpatient follow-ups were performed 1, 6, 12 and 15 months subsequent to the PCI, respectively. The observation endpoints were major adverse cardiac events (MACEs), including cardiac death, non-fatal myocardial infarction (MI), restenosis, target lesion revascularization, stent thrombosis and recurrence of angina pectoris. The average follow-up time was 15 months. The results revealed that the cumulative incidences of MACEs were as follows: mortality, 0.99%; non-fatal MI, 0.74%; restenosis, 4.0%; and target lesion revascularization, 2.7%. The results at the short- and long-term clinical follow-ups indicated that YINYI™ stents are effective and safe for use in PCI for patients with CAD.

摘要

目前,人们越来越关注具有可生物降解聚合物涂层的支架,而非永久性聚合物涂层的支架。这是因为在植入具有永久性聚合物涂层的药物洗脱支架(DES)后,涂层的持续存在可能会导致异物反应和延迟再内皮化。本研究的目的是评估一种非聚合物紫杉醇洗脱微孔(YINYI™)支架在冠状动脉疾病(CAD)患者的实际经皮冠状动脉介入治疗(PCI)中的安全性和有效性。在PCI手术中,共对404例CAD患者植入了686个YINYI™支架,并在PCI术后1、6、12和15个月分别进行了门诊随访。观察终点为主要不良心脏事件(MACE),包括心源性死亡、非致命性心肌梗死(MI)、再狭窄、靶病变血管重建、支架血栓形成和心绞痛复发。平均随访时间为15个月。结果显示,MACE的累积发生率如下:死亡率为0.99%;非致命性MI为0.74%;再狭窄为4.0%;靶病变血管重建为2.7%。短期和长期临床随访结果表明,YINYI™支架用于CAD患者的PCI是有效且安全的。

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