Dante Pazzanese Institute of Cardiology, Av Dante Pazzanese, 500, Vila Mariana, São Paulo 04012-180, Brazil.
Int J Cardiovasc Imaging. 2013 Jun;29(5):977-88. doi: 10.1007/s10554-013-0188-8. Epub 2013 Mar 3.
First generation drug-eluting stents (DES) are associated with reduced in-stent restenosis but significant increased risk of very late stent thrombosis (VLST). The absence of polymer in DES systems may reduce the occurrence of VLST. Optic coherence tomography (OCT) has been used for stent analysis as a surrogate safety endpoint. This study aimed to assess the long-term follow up of strut apposition and tissue coverage of BioMatrix DES by OCT. 20 patients undergoing BioMatrix DES (n = 15) or S-Stent BMS (n = 5) implantation were followed for at least 5 years and evaluated by quantitative coronary angiography, intravascular ultrasound, and OCT. The difference between the stent types was evaluated by nonparametric Mann-Whitney U test while categorical variables were evaluated by Fisher exact test. Rates of in-stent late loss were similar between groups [0.40 (0.21;0.77) vs. 0.68 (0.66; 0.82) mm, p = 0.205, for BioMatrix and S-Stent, respectively]. The vessel, stent and lumen volumes did not differ between groups. Patients treated with BioMatrix had significantly less stent obstruction [5.6 (4.4;9.7) vs. 28.6 (24.7;29.0) %, p = 0.001]. OCT analysis of 12 stents (Biomatrix = 9 and S-Stent = 3) demonstrated 126 (8.7 %) uncovered struts in the BioMatrix group compared to 23 (4.0 %) in the S-Stent group (p = 0.297), being the majority of them well apposed (117/126 and 21/23, respectively, p = 0.292). Only 9 (0.6 %) struts in the DES and 2 (0.4 %) struts in the BMS groups were simultaneously uncovered and malapposed (p = 0.924). BioMatrix DES was associated with lower rates of in-stent obstruction, and similar percentage of neointimal coverage on struts and of complete strut apposition.
第一代药物洗脱支架(DES)可降低支架内再狭窄,但明显增加极晚期支架血栓形成(VLST)的风险。DES 系统中无聚合物的存在可能会降低 VLST 的发生。光相干断层扫描(OCT)已被用于支架分析作为替代安全性终点。本研究旨在通过 OCT 评估 BioMatrix DES 的支架贴壁和组织覆盖的长期随访结果。20 名患者接受 BioMatrix DES(n=15)或 S-Stent BMS(n=5)植入治疗,并至少随访 5 年,采用定量冠状动脉造影、血管内超声和 OCT 进行评估。采用非参数 Mann-Whitney U 检验评估支架类型间的差异,采用 Fisher 确切检验评估分类变量。两组间支架内晚期丢失率相似[0.40(0.21;0.77)比 0.68(0.66;0.82)mm,p=0.205,BioMatrix 和 S-Stent 分别]。两组间血管、支架和管腔体积无差异。接受 BioMatrix 治疗的患者支架阻塞程度显著较低[5.6(4.4;9.7)比 28.6(24.7;29.0)%,p=0.001]。对 12 个支架(BioMatrix=9 个,S-Stent=3 个)的 OCT 分析显示,BioMatrix 组中有 126 个(8.7%)未覆盖的支架,而 S-Stent 组中有 23 个(4.0%)(p=0.297),其中大多数支架贴壁良好(117/126 和 21/23,p=0.292)。DES 组中有 9 个(0.6%)支架和 BMS 组中有 2 个(0.4%)支架同时出现未覆盖和贴壁不良(p=0.924)。BioMatrix DES 与较低的支架内阻塞率相关,且支架上新生内膜覆盖率和完全贴壁率相似。