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金属学报  2017, Vol. 53 Issue (10): 1215-1226    DOI: 10.11900/0412.1961.2017.00258
  研究论文 本期目录 | 过刊浏览 |
医用可降解血管支架临床研究进展
张小农1(), 左敏超1, 张绍翔2, 吴宏流1, 王文辉1, 陈文智1, 倪嘉桦1
1 上海交通大学材料科学与工程学院 上海 200240
2 苏州奥芮济医疗科技有限公司 苏州 215513
Advances in Clinical Research of Biodegradable Stents
Xiaonong ZHANG1(), Minchao ZUO1, Shaoxiang ZHANG2, Hongliu WU1, Wenhui WANG1, Wenzhi CHEN1, Jiahua NI1
1 School of Materials Science and Engineering, Shanghai Jiao Tong University, Shanghai 200240, China
2 Suzhou Origin Medical Technology Co. Ltd., Suzhou 215513, China
引用本文:

张小农, 左敏超, 张绍翔, 吴宏流, 王文辉, 陈文智, 倪嘉桦. 医用可降解血管支架临床研究进展[J]. 金属学报, 2017, 53(10): 1215-1226.
Xiaonong ZHANG, Minchao ZUO, Shaoxiang ZHANG, Hongliu WU, Wenhui WANG, Wenzhi CHEN, Jiahua NI. Advances in Clinical Research of Biodegradable Stents[J]. Acta Metall Sin, 2017, 53(10): 1215-1226.

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摘要: 

心血管疾病是危害国人身体健康的第一大疾病,介入治疗已成为患者的重要选择,植入血管支架被认为是目前最便捷有效的技术。本文在简单介绍经皮冠脉介入治疗的发展历程的基础上,综合比较了美国雅培公司研发的生物可吸收高分子支架以及德国百多力公司研发的生物可降解镁合金支架的一系列随机临床实验数据,总结了可降解吸收支架目前存在的缺陷并分析了其未来的发展趋势。
关键词 ： 介入治疗,  生物可吸收高分子支架,  可降解镁合金支架,  血栓,  管腔丢失    
Abstract：

Cardiovascular disease has become the first major disease that is harmful to people's health, vascular stents and other percutaneous coronary interventions are considered the most important and effective treatment technology of cardiovascular disease. In this review, the development about percutaneous coronary interventions was simply introduced, through comparing a series of randomized clinical trial data of bioabsorbable vascular stents developed by Abbott of the United States and absorbable magnesium stents developed by Biotronik of Germany, summarizing the shortcomings and analyzing trend in the future of absorbable stents.
Key words： percutaneous coronary intervention    bioabsorbable vascular stent    absorbable magnesium stent    thrombosis    lumen loss
收稿日期: 2017-06-30     
ZTFLH:  TB31  
基金资助:国家自然科学基金项目No.51571142,国家重点研发计划项目No.2016YFC1102403和上海市科学技术委员会科研计划项目No.14441901801
作者简介:

作者简介 张小农,男,1969年生,副教授,博士
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张小农
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https://www.ams.org.cn/CN/10.11900/0412.1961.2017.00258      或      https://www.ams.org.cn/CN/Y2017/V53/I10/1215

图1  经皮冠脉介入治疗发展史[3]
图2  Absorb BVS 1.0与BVS 1.1支架结构比较[29]
Device thrombosis 30 d 1 a
BVS 2.1% 2.4%
EES 0.3% 1.4%
BMS 1.0% 1.7%
表1  全吸收式血管支架(BVS)、依维莫司药物洗脱支架(EES)和金属裸支架(BMS)支架血栓发生率比较[33]
Absorb AIDA BVS Co-Cr EES p
(n=924) (n=921)
TVF 11.7% 10.7% 0.43
Target-vessel MI 5.5% 3.2% 0.04
Cardiac death 2.0% 2.7% 0.43
TVR 8.7% 7.5% 0.37
Definite or probable 3.5% 0.9% <0.001
device thrombosis
表2  Absorb AIDA 的2 a临床结果[34]
Absorb III Absorb Xience p
(n=1322) (n=686)
TLF 7.8% 6.1% pNI=0.007
Rate of cardiac death 0.6% 0.1% 0.29
Target vessel MI 6.0% 4.6% 0.18
ID-TLR 3.0% 2.5% 0.50
Stent thrombosis 1.5% 0.7% 0.13
表3  Absorb III的1 a临床结果[36]
图3  Absorb BVS支架吸收时间图[3]
图4  扩张前后的可吸收镁合金支架[50]
图5  裸镁合金支架(AMS)植入前后的右冠状动脉近端血管造影图[49]
Scaffold Strut material Coating Eluted drug Strut thickness Radio-opacity Radial support Resorption
material μm month month
AMS Mg alloy None None 165 None 2 <4
DREAMS-1G Mg alloy with PLGA Paclitaxel 125 None 3~6 9
rare metal
DREAMS-2G Mg alloy with PLLA Sirolimus 150 Tantalum 3~6 9
rare metal marker
表4  可降解镁合金支架参数[3,49-51]
图6  手术后及第4个月随访右冠状动脉近端血管造影及局部血管内超声图[49]
图7  药物洗脱可降解镁合金支架植入不同时间的功能原理图[24]
图8  DREAMS-1G植入后、6个月及12个月冠脉内超声结果[50]
Trial Patient RVD / mm Length of lesion / mm Diameter stenosis
BIOSOLVE-I 46 3.0~3.5 <12 50%~99%
BIOSOLVE-II 123 2.2~3.7 <21 50%~99%
表5  BIOSOLVE系列临床实验病变参数[50,51]
图9  DREAMS-2G植入后及植入第6个月光学相干断层成像[51]
图10  可降解镁合金支架累计晚期管腔丢失对比[51]
Parameter AMS DREAMS-1G DREAMS-2G
Patient 63 46 123
Follow-up 4 months (n=63) 6 months (n=36) 12 months (n=34) 6 months (n=112)
In segment LLL / mm 0.83±0.51 0.52±0.48 0.39±0.33 0.27±0.37
In scaffold LLL / mm 1.08±0.49 0.65±0.50 0.52±0.39 0.44±0.36
In segment DS 49.66%±16.25% 29.02%±18.99% 25.31%±12.01% 25.9%±12.3%
In scaffold DS 48.37%±17.00% 25.01%±21.07% 20.92%±16.70% 22.6%±12.9%
In segment MLD / mm 1.34±0.49 1.84±0.52 1.96±0.43 2.55±0.41
In scaffold MLD / mm 1.38±0.51 1.95±0.59 2.06±0.47 2.59±0.40
TLF NA NA 7% 3%
Target vessel MI 0 NA 3% <1%
Clinically driven TLR 23.8% NA 4.3% 1.7%
Scaffold thrombosis 0 0 0 0
表6  可降解镁合金支架临床数据对比[49-51]
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