Evaluation of the Second Generation of a Bioresorbable Everolimus-Eluting Vascular Scaffold for the Treatment of De Novo Coronary Artery Stenosis 12-Month Clinical and Imaging Outcomes
Evaluation of the Second Generation of a Bioresorbable Everolimus-Eluting Vascular Scaffold for the Treatment of De Novo Coronary Artery Stenosis 12-Month Clinical and Imaging Outcomes
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DOI：
10.1016/j.jacc.2011.05.050
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发表时间：
2011-10-04
影响因子：
24
通讯作者：
Ormiston, John A.
中科院分区：
文献类型：
--
作者：
Serruys, Patrick W.;Onuma, Yoshinobu;Ormiston, John A.
目的本研究旨在证明防止ABSORB BVS的早期支架面积收缩（Rev.1.1，Abbott Vascular，Santa Clara，加州）的支架设计得到了持续，而不是简单地延迟了几个月。ABSORB的第二次迭代（BVS 1.1）具有改进的性能，以防止支架面积在6个月时减小。方法五十六例患者被登记并接受57个ABSORB支架。在基线和12个月随访时进行定量冠状动脉造影、血管内超声（IVUS）、射频背向散射分析、回声和光学相干断层扫描（OCT）。而支架的射频背向散射和回声强度下降了16.8%（p < 0.001）和20%（p < 0.001）;更具体地说，OCT上的支柱核心面积减少了11.4%（p = 0.003）。尽管没有支架面积损失，药理学血管舒缩恢复。在意向治疗基础上，血管造影晚期管腔丢失为0.27 +/- 0.32 mm，IVUS最小管腔面积相对减少1.94%（p = 0.12），平均管腔面积无显著变化。随访时的OCT显示96.69%的支柱被覆盖，最初在18个支架中观察到贴壁不良，但在随访时仅在4个支架中检测到贴壁不良。两名患者经历了围手术期和医源性心肌梗死，分别，而2进行了重复干预，导致主要不良心脏事件率为7.1%（456）。结论12个月的性能的第二代ABSORB生物可吸收依维莫司洗脱支架证明了对目前的最佳标准进行随机试验。（生物可吸收依维莫司洗脱冠状动脉支架系统[BVS EECSS]治疗原发性自体冠状动脉病变患者的临床评价; NCT 00856856）（J Am科尔Cardiol 2011; 58：1578-88）（C）2011，美国心脏病学会基金会
Objectives The aim of this study was to demonstrate that the prevention of early scaffold area shrinkage of the ABSORB BVS (Rev. 1.1, Abbott Vascular, Santa Clara, California) was sustained and not simply delayed by a few months.Background With improved scaffold design and modified manufacturing process of its polymer, the second iteration of ABSORB (BVS 1.1) has improved performance to prevent a scaffold area reduction at 6 months.Methods Fifty-six patients were enrolled and received 57 ABSORB scaffolds. Quantitative coronary angiography, intravascular ultrasound (IVUS), analysis of radiofrequency backscattering, echogenicity and optical coherence tomography (OCT) were performed at baseline and at 12-month follow-up.Results Overall the scaffold area remained unchanged with IVUS as well as with OCT, whereas the radiofrequency backscattering and the echogenicity of the struts decreased by 16.8% (p < 0.001) and 20% (p < 0.001), respectively; more specifically, the strut core area on OCT decreased by 11.4% (p = 0.003). Despite the absence of scaffold area loss, pharmacological vasomotion was restored. On an intention-to-treat basis, the angiographic late lumen loss amounted to 0.27 +/- 0.32 mm with an IVUS relative decrease in minimal lumen area of 1.94% (p = 0.12), without significant changes in mean lumen area. The OCT at follow-up showed that 96.69% of the struts were covered and that malapposition, initially observed in 18 scaffolds was only detected at follow-up in 4 scaffolds. Two patients experienced peri-procedural and iatrogenic myocardial infarction, respectively, whereas 2 underwent repeat intervention, resulting in the major adverse cardiac event rate of 7.1% (4 of 56).Conclusions The 12-month performance of the second-generation ABSORB bioresorbable everolimus-eluting scaffold justifies the conduct of a randomized trial against current best standards. (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System [BVS EECSS] in the Treatment of Patients With de Novo Native Coronary Artery Lesions; NCT00856856) (J Am Coll Cardiol 2011; 58: 1578-88) (C) 2011 by the American College of Cardiology Foundation