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摘要: 冠状动脉(冠脉)内药物洗脱支架的植入是治疗冠脉疾病的主要手段之一，该方法虽然显著减少了支架内狭窄及支架内血栓的发生率，但弊端是心脏永久保留了金属异物，同时涂层聚合物还可能导致血管的慢性炎症、再狭窄、新生内膜的粥样硬化以及晚期管腔丢失。为克服药物洗脱支架治疗冠脉疾病的局限性，出现了一种新的技术——生物可降解支架。然而在使用生物可降解支架时，支架内血栓的高发生率是一个不可忽视的问题，究其原因，可能与未选择合适患者、未进行PSP策略(预扩张、支架植入、后扩张)以及支架材料和生产工艺仍需改进相关。但这并不能阻挡生物可降解支架引发冠脉介入治疗的第4次革命。同时，生物可降解支架具有其独特的优势，如提供靶病变适当时间的机械支撑后恢复冠脉生理性的功能。本综述主要介绍生物可降解支架的发展历程、现状以及目前的困境。Abstract: The drug-eluting stent is currently the principal method to treat coronary artery disease. Although this method can significantly reduce the incidence of in-stent restenosis and stent thrombosis, the stent is a permanent metallic foreign body within the heart. Meanwhile, coating polymer may lead to chronic inflammation, in-stent restenosis, neointimal atherosclerosis, and late lumen loss. Researchers designed a new technology, the bioresorbable vascular scaffold(BVS), to overcome such problems. Indeed, BVS can cause a high incidence of stent thrombosis. This high incidence may be related to the failure to select appropriate patients, the failure to carry out PSP strategies(pre-expansion, stent-implantation, post-expansion), and the need to improve stent materials and production processes. Still, these reasons cannot stop BVS to trigger the fourth revolution of coronary artery intervention treatment. Besides, BVS also has its unique advantage, which is to restore the physiological function of the coronary artery after providing a proper time of mechanical support to the target lesion. This article introduces the development and current situation of BVS, as well as the difficulties it encounters at the moment.
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表 1 冠脉内生物可降解支架循证医学证据
Table 1. Evidence-based medicine of coronary artery bioresorbable vascular scaffold
研究 开始年份 随访时间/年 BVS支架(对照组支架) 入选患者数量/ 病变数量 主要终点及结果 支架内血栓 Igaki-Tamai stents研究[14] 1998—2000 10 Igaki-Tamai stents 50/63 TLR(TVR)的累积发生率：1年时16%(16%)，5年时18%(22%)，10年时28%(38%) 2例 ABSORB Ⅱ研究[17] 2011—2013 3 Abbott BVS (XIENCE支架) 335(166)/ 364(182) 第1个主要终点：血管舒缩反应性无差异；第2个主要终点：LLL率BVS组大于Xience组 BVS组不劣于Xience组 ABSORB Ⅲ研究[22] 2014 5 Abbott BVS (XIENCE支架) 1322(686)/ 1385(713) 1年时TLF：BVS组不劣于Xience组；2~5年时TLF：BVS组显著高于Xience组 BVS组劣于Xience组 ABSORB China研究[32] 2014 3 Abbott BVS (XIENCE支架) 241(239)/ 251(252) 3年时TLF：BVS组不劣于Xience组 2~3年内0例 BIOSOLVE-Ⅱ和-Ⅲ研究[23] 2013—2015 3 Magmaris 184/189 TLF：6.3%；心脏性死亡：2.3%；TVMI：0.6%；ID-TLR：3.4% 0例 BIOSOLVE-Ⅳ研究[24] 2016 1 Magmaris 1075/1121 1年时TLF：4.3% 5例 XINSORB研究[28] 2013—2014 5 XINSORB BVS 30/30 5年时TLF：13.3% 1例 XINSORB RCT研究[29] 2014—2015 4 XINSORB BVS (TIVOLI SES) 200(195)/ 210(216) 两组在TLF、PoCE、MACE、ID-TLR、TVMI、ID-TVR的差异均无统计学意义 BVS组2例 FUTURE-Ⅰ研究[6] 2016 4 Firesorb BVS 45/45 PoCE发生率为4.4% 0例 FUTURE-ⅡRCT研究[30] 2017—2019 1 Firesorb BVS (EES) 215(218)/ 221(226) 1年后造影显示节段内LLL不劣于EES 0例 NeoVas客观绩效研究[5] 2014—2016 1 NeoVas BVS 1103/1170 1年时TLF发生率为3%，显著低于8.5%的绩效目标 5例 NeoVas RCT研究[31] 2014—2015 3 NeoVas BVS (EES) 278(282)/ 278(283) 3年时TLF：BVS组不劣于Xience组 BVS组不劣于EES组 
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| 引用本文: |
陈思佟, 王悦喜, 刘晓宇. 冠状动脉内生物可降解支架研究现状[J]. 临床心血管病杂志, 2023, 39(1): 68-75. doi: 10.13201/j.issn.1001-1439.2023.01.013
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| Citation: |
CHEN Sitong, WANG Yuexi, LIU Xiaoyu. Research status of coronary artery bioresorbable vascular scaffold[J]. J Clin Cardiol, 2023, 39(1): 68-75. doi: 10.13201/j.issn.1001-1439.2023.01.013
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