Research Progress on Mechanism and Imaging Evaluation of In-Stent Restenosis After PCI
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摘要: 经皮冠状动脉介入治疗术（percutaneous coronary intervention，PCI）是目前全球范围内应用最广泛的心肌再灌注疗法，可有效提高冠心病和心肌梗死患者的生存率，改善患者的生存质量。然而，PCI术后由于支架内新生的内膜逐渐增厚演变为新生动脉内膜粥样硬化（neo-atherosclerosis，NA）斑块，导致支架内再狭窄（in-stent restenosis，ISR），甚至可破裂进展为急性心血管不良事件，严重影响患者预后。支架内再狭窄引起的进行性心绞痛和支架内血栓引起的急性心血管事件是PCI术后ISR的主要病理表现。支架内再狭窄是由患者因素、血管因素、机械及支架、解剖因素等的复杂作用介导形成的病理性新生内膜增生，有关其发病机制的研究正不断深入。本文通过综述心血管介入领域的影像学检查，内皮细胞的损伤和血栓的形成、血管平滑肌细胞（vascular smooth muscle cells，VSMCs）增殖迁移、炎症反应以及新动脉内膜粥样硬化等方面对其进行综述，探讨ISR病理机制及其临床意义。
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关键词:
- 经皮冠状动脉介入治疗 /
- 药物洗脱支架 /
- 支架内再狭窄 /
- 新生动脉粥样硬化
Abstract: Percutaneous coronary intervention （PCI） is currently the most widely used myocardial reperfusion therapy worldwide and is effective in increasing survival rates and improving quality of life in patients with coronary artery disease and myocardial infarction. However, the progressive thickening of neo-atherosclerotic （NA） plaques after PCI can lead to in-stent restenosis （ISR）, which can even rupture and progress to acute adverse cardiovascular events, seriously affecting patient prognosis. Progressive angina due to in-stent restenosis and acute cardiovascular events due to in-stent thrombosis are the main pathological manifestations of ISR after PCI. Intra-stent restenosis is a pathological neointimal hyperplasia mediated by a complex combination of patient factors, vascular factors, mechanical and stenting, and anatomical factors, and research on its pathogenesis is ongoing. This article provides an in-depth discussion of the pathogenesis of ISR and its clinical implications by reviewing imaging in the interventional field, endothelial cell injury and thrombus formation, vascular smooth muscle cell （VSMCs） proliferation and migration, inflammatory response, and neointimal atherosclerosis. -
图 1 小型猪PCI术后28 d血管内影像及相应组织学切片[33]
（A）AS小型猪PCI术后28 d冠状动脉造影，红色箭头示ISR；（B）小型猪支架植入术后28 d OCT代表图像，红色箭头示新生内膜增生；（C）支架植入术后28 d HE染色结果；黑点代表支架杆。
Figure 1. Intravascular Imaging and Corresponding Histological Sections 28 Days Post-PCI in Minipigs
图 2 PCI术后内皮细胞损伤与病理改变
TM：血栓调节蛋白； EC：内皮细胞； TFPI：组织因子途径抑制物； PAI-1：纤溶酶原激活物抑制剂-1； tPA：组织型纤溶酶原激活物； vWF：血管性血友病因子； GPIIb / IIIa：糖蛋白IIb / IIIa； TF:组织因子； NO：一氧化氮； ROS：活性氧； TLR：支架植入后靶病变血运重建； ST：支架血栓。
Figure 2. Pathological changes and endothelial cell injury after PCI
图 3 ISR中VSMCs表型转换与迁移模式
OPN: 骨桥蛋白; MMPs: 基质金属蛋白酶。
Figure 3. Pattern of phenotypic switching and migration of VSMCs in ISR
表 1 药物洗脱支架技术、药物学及PCI技术迭代时间轴
Table 1. Timeline of Technologic Iterations in Drug-eluting Stent Technologies，Pharmacology，and PCI Techniques
时间 里程碑事件 1977-1990年 球囊成形术时代 1977年，Andreas Gruentzig首创冠状动脉球囊成形术，但该技术很快暴露出一个关键缺陷：负性血管重构所致ISR。随后，FDA批准Palmaz-Shatz支架这一首个裸金属支架（BMS）上市，标志着急性心肌梗死介入治疗的重要进步。同期，Colombo团队基于IVUS影像建立了ISR分类体系。 1990-2000年 裸金属支架（BMS）时代 这一时期，随着去除粥样斑块的消融装置不断推出和完善，ISR的特征逐渐被更加充分地认识。借助IVUS等工具，血管造影评估更加精细，BMS相关再狭窄的机制得到进一步澄清。对于BMS所致ISR，近距离放疗、旋磨术和准分子激光斑块消蚀术等技术陆续应用；与此同时，双联抗血小板治疗逐渐成为降低支架血栓风险的重要策略。 2000-2010年 第一代药物洗脱支架（DES）时代 为应对第一代DES相关晚期支架血栓问题，双联抗血小板治疗时间被延长。随后，FDA批准Cypher西罗莫司洗脱支架和Taxus紫杉醇洗脱支架用于临床。同时，更强效的抗血小板药物，如P2Y12受体抑制剂，也显著优化了治疗策略。 2010-2015年 第二代药物洗脱支架（DES）时代 这一时期，依维莫司和西罗莫司相关DES相继获得临床应用批准。研究逐渐认识到，新动脉粥样硬化在DES远期失败中发挥关键作用。为此，FDA批准了可吸收支架以及采用可吸收聚合物的药物洗脱支架，以期改善上述问题。 2015-2020年 最新一代药物洗脱支架技术 这一时期，FDA批准了Orsiro支架，即一种超薄型西罗莫司涂层、生物可吸收聚合物支架。尽管设计先进，生物可吸收支架随后因支架血栓（ST）和ISR发生率较高而退出市场。无聚合物生物活性药物洗脱支架在高出血风险患者中显示出优于BMS的效果，可缩短DAPT疗程，并推动PCI后无阿司匹林抗栓方案的应用。 
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表 2 不同类型支架ISR的影像学与组织学特征
Table 2. Imaging and Histological Features of ISR with Different Stent Types
支架类型 血管造影特征[16] OCT特征[35] IVUS特征[25] 组织学特征[36] BMS 弥漫型ISR 组织分布较均一。 病变长度>10 mm且最小管腔面积（MLA）<4 mm2提示弥漫型ISR，主要分为局限于支架体部的“支架内弥漫型”和超出支架边界的“边缘弥漫型”。 主要表现为VSMCs增殖、蛋白多糖中度沉积；内皮化通常于3～6个月内完成；血栓形成及新动脉粥样硬化相对少见。 第一代DES 更常见局灶型或支架边缘型ISR。 均质性新生内膜，平滑肌细胞及细胞外基质较少。 病变通常局限于支架内，也可向支架边缘延伸；多灶性ISR时，病灶可散在分布于支架体部及其周边。 主要特征为平滑肌细胞稀少、蛋白多糖含量增高、内皮化延迟（可超过1年）；并可伴发偶发性血栓形成及快速进展的新动脉粥样硬化。 新一代DES 更常见局灶型或支架边缘型ISR。 与BMS相比，新动脉粥样硬化组织非均质性更明显，但其进展速度慢于早期DES，且脂质含量低于早期DES。 ISR多局限于支架内，仅轻度累及支架边缘。 主要表现为平滑肌细胞稀少、蛋白多糖含量高、血管周围炎症轻微；内皮化通常于3～6个月完成；血栓形成较少见，但远期常可观察到新动脉粥样硬化。
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表 3 ISR的易感因素
Table 3. Predisposing Factors for ISR
诱因 具体内容 患者因素 糖尿病、高龄慢性肾病、既往PCI或CABG史、肥胖、遗传易感性以及对抗增殖药物反应不佳等，均为ISR危险因素。 血管因素 血管钙化、分叉及开口部病变、小血管病变、多支血管病变、PCI后ISR、慢性闭塞病变及移植后大隐静脉桥血管病变等，均可能促进ISR发生。 操作及支架相关因素 导致支架效果欠佳的因素包括支架扩张不全、支架断裂、支架重叠、支架定位不当、支架涂层不规则导致药物分布不均、对聚合物成分高度敏感，以及残留未覆盖的粥样硬化斑块持续存在等。 解剖学因素 血管直径、病变性质及局部剪切应力是影响支架结局的重要因素。
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