两年期可生物降解聚合物药物洗脱支架与耐用聚合物药物洗脱支架的血管反应：NEXT研究的光学相干断层扫描子研究

Two-year vascular responses to drug-eluting stents with biodegradable polymer versus durable polymer: An optical coherence tomography sub-study of the NEXT.

作者信息

Katayama Yosuke, Kubo Takashi, Akasaka Takashi, Ino Yasushi, Kimura Kazuo, Okura Hiroyuki, Shinke Toshiro, Igarashi Keiichi, Kadota Kazushige, Kozuma Ken, Tanabe Kengo, Nakagawa Yoshihisa, Muramatsu Toshiya, Morino Yoshihiro, Kimura Takeshi

机构信息

Department of Cardiovascular Medicine, Wakayama Medical University, Wakayama, Japan.

出版信息

J Cardiol. 2017 Dec;70(6):530-536. doi: 10.1016/j.jjcc.2017.04.005. Epub 2017 May 20.

DOI:10.1016/j.jjcc.2017.04.005

PMID:28536015

Abstract

BACKGROUND

This study aimed to compare very late vascular response after stent implantation between everolimus-eluting stent (EES) with a thin, non-adhesive, durable, biocompatible fluorinated polymer and biolimus-eluting stent (BES) with a biodegradable polymer by optical coherence tomography (OCT).

METHODS AND RESULTS

In the NOBORI-BES Versus XIENCE V/PROMUS-EES Trial (NEXT), a formal OCT substudy investigated 48 patients (27 EES-treated lesions in 23 patients and 28 BES-treated lesions in 25 patients) with 2-year (18-30 months) follow-up imaging at 18 centers. The percentage of uncovered strut by neointima was significantly lower in EES compared with BES (2.1±4.7% vs. 7.9±10.8%, p=0.013). The percentage of malapposed strut was not different between EES and BES (0.1±0.3% vs. 0.5±1.3%, p=0.138). The frequency of stent with evagination, which is identified as outward bulges in the luminal contour between struts, was significantly lower in EES compared with BES (22% vs. 86%, p<0.001). The frequency of neoatherosclerosis was not different between EES and BES (11% vs. 11%, p=1.000).

CONCLUSIONS

At 2 years after stent implantation, uncovered stent strut by neointima and evagination were less frequently observed in EES compared with BES. This OCT study suggests that the very late vascular response is different between EES and BES.

摘要

背景

本研究旨在通过光学相干断层扫描（OCT）比较采用薄的、非粘性的、耐用的、生物相容性含氟聚合物的依维莫司洗脱支架（EES）与采用可生物降解聚合物的生物雷帕霉素洗脱支架（BES）植入术后极晚期血管反应。

方法与结果

在NOBORI-BES与XIENCE V/PROMUS-EES试验（NEXT）中，一项正式的OCT子研究在18个中心对48例患者（23例患者中的27个接受EES治疗的病变和25例患者中的28个接受BES治疗的病变）进行了为期2年（18 - 30个月）的随访成像。与BES相比，EES中被新生内膜覆盖的支架小梁百分比显著更低（2.1±4.7%对7.9±10.8%，p = 0.013）。EES和BES之间贴壁不良支架小梁的百分比无差异（0.1±0.3%对0.5±1.3%，p = 0.138）。被定义为支架小梁之间管腔轮廓向外凸起的支架外翻频率，EES显著低于BES（22%对86%，p<0.001）。EES和BES之间新动脉粥样硬化的频率无差异（11%对11%，p = 1.000）。