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在12个月随访时,基于定量冠状动脉造影和光学相干断层扫描,对三种具有不同平台但使用相同可生物降解聚合物和药物的药物洗脱支架进行比较评估。

Comparative assessment of three drug eluting stents with different platforms but with the same biodegradable polymer and the drug based on quantitative coronary angiography and optical coherence tomography at 12-month follow-up.

作者信息

Gil Robert J, Bil Jacek, Legutko Jacek, Pawłowski Tomasz, Gil Katarzyna E, Dudek Dariusz, Costa Ricardo A

机构信息

Department of Invasive Cardiology, Central Clinical Hospital of the Ministry of Interior and Administration, 137 Woloska Street, 02-507, Warsaw, Poland.

Mossakowski Medical Research Centre, Polish Academy of Science, Warsaw, Poland.

出版信息

Int J Cardiovasc Imaging. 2018 Mar;34(3):353-365. doi: 10.1007/s10554-017-1251-7. Epub 2017 Sep 30.

Abstract

The aim of this study was to compare neointima proliferation in three drug-eluting stents (DES) produced by the same company (Balton, Poland) which are covered with a biodegradable polymer and elute sirolimus (concentration: 1.0 and 1.2 µg/mm), but have different stent platforms and strut thickness: stainless steel Prolim (115 µm) and BiOSS LIM (120 µm) and cobalt-chromium Alex (70 µm). We analyzed data of patients with quantitative coronary angiography (QCA) and optical coherence tomography (OCT) at 12 months from BiOSS LIM Registry, Prolim Registry and Alex OCT clinical trial. There were 56 patients enrolled, in whom 29 Prolim stents were deployed, in 11-BiOSS LIM and in 16-Alex stents. The late lumen loss was the smallest in Prolim subgroup (0.26 ± 0.17 mm) and did not differ from Alex subgroup (0.28 ± 0.47 mm). This parameter was significantly bigger in BiOSS subgroup (0.38 ± 0.19 mm; p < 0.05). In OCT analysis there was no statistically significant difference between Prolim and Alex subgroups in terms of mean neointima burden (24.6 ± 8.6 vs. 19.27 ± 8.11%) and neointima volume (28.16 ± 15.10 vs. 24.51 ± 17.64 mm). In BiOSS group mean neointima burden (30.9 ± 6.2%) and mean neointima volume (44.9 ± 4.9 mm) were significantly larger. The morphological analysis revealed that in most cases in all groups the neointima was homogenous with plaque presence only around stent struts. In the QCA and OCT analysis regular DES (Prolim and Alex) obtained similar results, whereas more pronounced response from the vessel wall was found in the BiOSS subgroup.

摘要

本研究的目的是比较由同一家公司(波兰的Balton)生产的三种药物洗脱支架(DES)的新生内膜增殖情况,这三种支架均覆盖有可生物降解聚合物并洗脱西罗莫司(浓度:1.0和1.2μg/mm),但具有不同的支架平台和支柱厚度:不锈钢Prolim(115μm)、BiOSS LIM(120μm)和钴铬合金Alex(70μm)。我们分析了来自BiOSS LIM注册研究、Prolim注册研究和Alex OCT临床试验的患者在12个月时的定量冠状动脉造影(QCA)和光学相干断层扫描(OCT)数据。共纳入56例患者,其中植入了29枚Prolim支架、11枚BiOSS LIM支架和16枚Alex支架。晚期管腔丢失在Prolim亚组中最小(0.26±0.17mm),与Alex亚组(0.28±0.47mm)无差异。该参数在BiOSS亚组中显著更大(0.38±0.19mm;p<0.05)。在OCT分析中,Prolim亚组和Alex亚组在平均新生内膜负荷(24.6±8.6%对19.27±8.11%)和新生内膜体积(28.16±15.10对24.51±17.64mm)方面无统计学显著差异。在BiOSS组中,平均新生内膜负荷(30.9±6.2%)和平均新生内膜体积(44.9±4.9mm)显著更大。形态学分析显示,在所有组的大多数情况下,新生内膜是均匀的,仅在支架支柱周围存在斑块。在QCA和OCT分析中,常规DES(Prolim和Alex)获得了相似的结果,而在BiOSS亚组中发现血管壁的反应更明显。

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