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Resolute Onyx 佐他莫司洗脱冠状动脉支架系统治疗冠状动脉疾病的器械特征:安全性和疗效概述。

Device profile of the Resolute Onyx Zotarolimus eluting coronary stent system for the treatment of coronary artery disease: overview of its safety and efficacy.

机构信息

The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

Department of Internal Medicine/Cardiology, Charité-Universitätsmedizin Berlin, Berlin, Germany.

出版信息

Expert Rev Med Devices. 2020 Apr;17(4):257-265. doi: 10.1080/17434440.2020.1736037. Epub 2020 Mar 10.

Abstract

: The increasing complexity of patients undergoing percutaneous coronary intervention (PCI) regarding both coronary anatomy and comorbidities requires dedicated devices. The Resolute Onyx (R-Onyx, Medtronic, CA, USA) stent is a novel durable polymer zotarolimus-eluting stent (ZES) promising better deliverability, increased radiopacity and lower thrombogenicity.: In this review, we discuss device features, preclinical evidence, and clinical studies including patients treated with R-Onyx. The BIONYX and Onyx ONE studies were two major landmark trials demonstrating non-inferiority of R-Onyx as compared to other latest generation devices. We also elaborate on alternative innovations in drug-eluting stent (DES) technology and how R-Onyx fits into this field.: R-Onyx is designed to address the challenges of contemporary PCI, but evidence on its clinical performance is largely derived from studies on older generation devices from the ZES family. Nonetheless, all clinical studies on R-Onyx consistently show excellent outcomes, with particularly low rates of stent thrombosis, making it a promising candidate for short dual antiplatelet regimens. In addition, R-Onyx is available with a wide range of stent diameters allowing accurate sizing for both very small and very large coronary vessels.

摘要

: 经皮冠状动脉介入治疗(PCI)患者的冠状动脉解剖结构和合并症日益复杂,需要专门的器械。Resolute Onyx(R-Onyx,美敦力,加利福尼亚州,美国)支架是一种新型的持久聚合物佐他莫司洗脱支架(ZES),具有更好的输送性、更高的射线可透性和更低的血栓形成性。: 在这篇综述中,我们讨论了器械的特点、临床前证据以及包括接受 R-Onyx 治疗的患者在内的临床研究。BIONYX 和 Onyx ONE 两项主要的标志性试验表明,与其他最新一代器械相比,R-Onyx 具有非劣效性。我们还详细介绍了药物洗脱支架(DES)技术的其他创新,并阐述了 R-Onyx 在这一领域的应用。: R-Onyx 旨在应对当代 PCI 的挑战,但它的临床性能证据主要来自于 ZES 家族的上一代器械研究。然而,所有关于 R-Onyx 的临床研究都显示出了出色的结果,尤其是支架血栓形成的发生率非常低,这使其成为短期双联抗血小板治疗的有前途的候选药物。此外,R-Onyx 有多种支架直径可供选择,可精确匹配非常小和非常大的冠状动脉血管。

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