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Malapposed Struts with Cre8, Biomatrix, and Xience Stents Assessed with OCT Immediately after Implantation and at 6-Month Follow-Up: Can the Different Biomechanical Characteristics of the Three Stents Impact on Struts Malapposition?
Journal of Interventional Cardiology ( IF 2.1 ) Pub Date : 2021-04-10 , DOI: 10.1155/2021/6611486
Cristina Giglioli 1, 2 , Emanuele Cecchi 1 , Chiara Formentini 3 , Marco Chiostri 3 , Niccolò Marchionni 1, 3 , Salvatore Mario Romano 1, 3
Affiliation  

Background. Although the clinical effects of stent malapposition remain controversial, several analyses of stent registries consistently have found that malapposed struts were frequently identified in patients who experienced stent thrombosis. In this study, which is a subanalysis of the previously published CREBX-OCT study, we compared optical coherence tomography (OCT) analysis at the index percutaneous coronary intervention (PCI) and at six-month follow-up in 37 patients randomly assigned to receive, by a single operator, three different second-generation drug-eluting stents (Cre8, Biomatrix, and Xience) aiming to clarify if the malapposition observed at six-month follow-up was persistent or late-acquired. Moreover, we investigated if there were some differences in the behavior of the three different kinds of stents in relation to the struts malapposition. Material and Methods. We analyzed 614 and 599 cross sections and 5514 and 5377 struts at the index PCI and at six-month follow-up, respectively. The qualitative analysis of the plaque composition among the three groups did not show significant differences. Results. The lumen area did not significantly change from the index procedure to the six-month follow-up in the three groups; on the contrary, the number of malapposed struts increased significantly in the Cre8 and Biomatrix groups but not in the Xience group: 0.58 ± 1.51 and 3.29 ± 5.33 () in the Cre8 group, 0.55 ± 1.81 and 1.73 ± 2.28 () in the Biomatrix group, and 0.55 ± 1.5 and 0.25 ± 0.87 () in the Xience group, respectively. Conclusions. Therefore, the malapposition observed at six-month follow-up in our study population could be mainly considered as acquired and attributable to biomechanical reasons due to the structural differences among the three stents. This trial is registered with Clinical Trials.gov Identifier: NCT02850497.

中文翻译:

植入后立即并在6个月的随访中立即对评估为OCT的Cre8,生物基质和Xience支架的支撑不良:三个支架的不同生物力学特性是否会影响支撑不良?

背景。尽管支架贴壁不良的临床效果仍存在争议,但对支架注册表进行的多项分析一致地发现,在经历支架血栓形成的患者中经常发现贴壁不良的支杆。在本研究中,这是先前发表的CREBX-OCT研究的子分析,我们比较了在37例随机分配接受接受经皮冠状动脉介入治疗(PCI)和六个月随访的患者中的光学相干断层扫描(OCT)分析,由一位操作者完成,目的是弄清六个月随访中观察到的错位是持续性的还是后发性的,这是由三个不同的第二代药物洗脱支架(Cre8,Biomatrix和Xience)组成的。而且,材料和方法。我们分别在索引PCI和六个月的随访中分析了614和599的横截面以及5514和5377的支撑。三组之间斑块组成的定性分析未显示显着差异。结果。在三组中,从指标程序到六个月的随访,管腔面积没有显着变化。相反,在Cre8和Biomatrix组中,错位撑杆的数量显着增加,但在Xience组中则没有增加:0.58±1.51和3.29±5.33(在Cre8组中为0.55±1.81和1.73±2.28((生物矩阵组)和0.55±1.5和0.25±0.87(分别位于Xience组中。结论。因此,在我们研究的人群中,在六个月的随访中观察到的错位可以主要被认为是获得性的,并且由于三个支架之间的结构差异而归因于生物力学原因。该试验已在Clinical Trials.gov标识符中注册:NCT02850497。
更新日期:2021-04-11
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