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Drug-eluting bioresorbable scaffolds in cardiovascular disease, peripheral artery and gastrointestinal fields: a clinical update.
Expert Opinion on Drug Delivery ( IF 6.6 ) Pub Date : 2020-05-27 , DOI: 10.1080/17425247.2020.1764932
Hideyuki Kawashima,Masafumi Ono,Norihiro Kogame,Kuniaki Takahashi,Chun-Chin Chang,Hironori Hara,Chao Gao,Rutao Wang,Mariusz Tomaniak,Rodrigo Modolo,Joanna J Wykrzykowska,Robbert J De Winter,Faisal Sharif,Patrick W Serruys,Yoshinobu Onuma

Introduction

The technology of bioresorbable scaffold (BRS) spread out after the success of the first-in-man trials of the Absorb. However, the randomized trials demonstrated that major adverse cardiac events and scaffold thrombosis rates of the first-generation Absorb were higher than those of the metallic everolimus-eluting stent. To overcome the shortcoming of the firstly commercialized Absorb, novel technologies have been developed.

Areas covered

In this review, we overviewed the field of BRS in the treatment of coronary, peripheral artery and gastrointestinal fields. To date, 10 BRS devices developed by 6 manufacturers have acquired the CE mark in coronary artery disease. Currently 8 BRS are in clinical trial phase, whereas 7 BRS are in preclinical assessment phase. Most new-generation devices have a strut thickness of less than 100 μm. However, late favorable outcome might be achieved not only by device refinement but also by a proper technique of implantation using intra vascular imaging guidance, as well as with a careful patient and lesion selection.

Expert opinion

New-generation BRS will be soon tested in the clinical arena to demonstrate improved acute and long-term of safety and efficacy.



中文翻译:

心血管疾病,外周动脉和胃肠道领域的药物洗脱生物可吸收支架:临床更新。

介绍

在Absorb的首次人体试验成功之后,生物可吸收支架(BRS)技术得以推广。但是,随机试验表明,第一代Absorb的主要不良心脏事件和支架血栓形成率高于金属依维莫司洗脱支架。为了克服首先商业化的Absorb的缺点,已经开发了新技术。

覆盖区域

在这篇综述中,我们概述了BRS在冠状动脉,外周动脉和胃肠道领域的治疗。迄今为止,由6家制造商开发的10种BRS设备已获得了冠状动脉疾病的CE标志。目前,有8个BRS处于临床试验阶段,而有7个BRS处于临床前评估阶段。大多数新一代设备的支撑杆厚度都小于100μm。然而,不仅可以通过设备改进,而且可以通过使用血管内成像指导的适当植入技术,以及仔细的患者和病变选择,来达到晚期良好的预后。

专家意见

新一代BRS将很快在临床上进行测试,以证明改善的急性和长期安全性与有效性。

更新日期:2020-07-21
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