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医用可降解血管支架临床研究进展 张小农
医用可降解血管支架临床研究进展 张小农
医用可降解血管支架临床研究进展 张小农
10
2017 年 10 月 ACTA METALLURGICA SINICA Oct. 2017
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
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
中图分类号 TB31 文章编号 0412-1961(2017)10-1215-12
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 per-
cutaneous coronary interventions was simply introduced, through comparing a series of randomized clini-
cal 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 magne-
sium stent, thrombosis, lumen loss
随着现代社会的高速发展,人口老龄化程度加 血管疾病不仅给人们带来了极大的痛苦,昂贵的医
剧,人们的工作压力不断增大,导致我国心血管疾病 疗费用也造成了患者本人、家庭和社会严重的经济
频发,并成为危害国人身体健康的第一大疾病。心 负担,增加了失能和残障的机率,造成了巨大的劳动
力损失。因此,对于心血管疾病治疗的研究具有重
资助项目 国家自然科学基金项目 No.51571142,国家重点研发
要意义,其防治已经成为国内外医学界关注的重点。
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 在大多数情况下,医患双方均倾向于药物和保
收稿日期 2017-06-30 定稿日期 2017-07-31 守治疗 [1,2]。但在特殊情况下,对于心血管疾病重症
作者简介 张小农,男,1969 年生,副教授,博士
患者,植入血管支架等高效、微创的腔内介入治疗凭
通讯作者 张小农,xnzhang@sjtu.edu.cn,主要从事生物医用镁金
借其创伤小、效果佳的优势被认为是目前最重要、最
属和钛金属的研究和相关植入医疗器械研发
DOI 10.11900/0412.1961.2017.00258 有效的心血管疾病诊疗技术。随着全球冠心病发病
1216 金 属 学 报 53 卷
图 1 经皮冠脉介入治疗发展史[3]
Fig.1 Development of percutaneous coronary intervention[3]
10 期 张小农等:医用可降解血管支架临床研究进展 1217
降解吸收支架就是基于这样的理念而研发出来的。 类支架层出不穷。在国际上,血管支架主要由雅培、
生物可吸收支架的研发历史可追溯到 1988 年, 波士顿科学、美敦力等巨头所垄断。在产品的更新
Stack[19] 和 Chapman 等 [20] 率先研制出生物可吸收支 换代方面,除了雅培已推出新一代生物全吸收高分
架,将支架植入到 5 只猪的股动脉中,在规定的时间 子支架外,市场上仍旧以药物洗脱支架为主导产
点,血管造影术(angiography)和组织病理学(histopa- 品。在国内,血管支架的国产化进程较快,已打破国
thology)特征显示,血管通畅率良好,没有炎症反应 内冠脉支架系统由国外巨头企业所垄断的局面。
和严重的血栓形成,这拉开了生物可降解支架的研
2 生物可吸收高分子支架
发序幕。1998 年,Yamawaki 等[21]研发出了第一个真
正意义上的可完全降解吸收的左旋聚乳酸(PLLA) 近 10 年来,生物可吸收支架领域最引人瞩目的
支架。在支架表面涂覆酪氨酸激酶抑制剂 ST638 或 当属美国雅培公司研发的 Absorb 系列全吸收式血
它的无活性代谢物 ST494。这是一种特殊的酪氨酸 管支架(bioresorbable vascular stent,BVS),这也是目
激酶抑制剂,可有效地抑制血管壁新生内膜增生及 前唯一取得美国 FDA 注册以及欧盟 CE 认证的完全
几何重塑,从而降低再狭窄率。在此基础上,2000 可降解支架。Absorb BVS 支架采用人体可吸收的
年,Tamai 等[22]首先报道了 Igaki-Tamai 聚合物支架的 高 分 子 材 料 PLLA 作 为 支 架 主 体 ,外 消 旋 聚 乳 酸
临床实验,这是第一支用于临床研究的生物可吸收 (PDLLA)作为载药涂层,选用依维莫斯(雷帕霉素的
支架,他们将 25 枚聚合物支架植入到 15 例患者体 衍生物)作为洗脱药物,支架厚度约为 156 mm[24,25]。
内,血管内超声(IVUS)显示术后支架并未发生明显 BVS 植入后为病变血管提供了暂时性的支撑,作用
的急性弹性回缩,3~10 a 的随访也反映了良好的长 一定时间后便通过降解及人体新陈代谢转变为 H2O
期临床结果。尽管实验结果令人满意,但该聚合物 和 CO2 排出体外,这避免了永久性金属异物存留在
支架的进一步研究应用却停止了,主要原因是该聚 血管内影响血管正常舒缩的现象,减少了切应力对
合物支架在被导管输入到靶病变位置时,其支架的 血管壁的持续刺激,降低了新生动脉粥样硬化发生
膨胀需要通过加热(70~80 ℃)才能实现,这有可能由 的风险。
于血管内加热而造成动脉壁坏死并导致新生内膜过 BVS 能否成功应用受到以下几个条件所制约:
度增生,还有可能促进血小板聚集黏附导致支架内 第一,高分子支架的力学性能必须要能与传统金属
血栓的形成,对患者的生命健康造成严重影响。虽 支架的力学性能相匹配,已有研究[26]说明,高分子支
然这些担忧在此后的实验中并未得到证实,但考虑 架植入后的急性回缩与金属支架类似;第二,高分子
到实验对象都是低危患者,因此该支架仅在欧洲被 支架的降解过程不能引起严重的炎症反应,从而避
批准用于外周血管疾病治疗。2006 年,Peuster 等 [23] 免晚期血管再狭窄。理想情况下,当高分子支架降
加工出了一种可降解的纯 Fe 支架,该支架的厚度约 解完全后,血管内应形成完整的、连续性好的新生血
0.12 mm,扩展后的支架直径为 6~12 mm,将支架植 管壁膜层;第三,在长期的随访中,血管及支架的扩
入到 27 只雄性迷你猪的降主动脉中,组织病理学研 张要足以弥补管腔内内膜生长而造成的管腔丢失,
究表明,在迷你猪的血液中未观察到 Fe3+ 过载及与 有效预防支架内晚期血栓的形成。这些限制条件对
Fe 相关的器官毒性的现象。在此后的随访中,血管 于目前的生物可吸收支架来说都是极大的挑战。
造影及血管内超声显示,未发生血管全闭塞和支架 Absorb Cohort A[25] 临床实验中,相对于常规的 DES
内血栓事件,这说明了纯 Fe 作为一种生物可吸收支 而言,BVS 1.0 有较高的晚期再狭窄率。之后雅培对
架材料的可行性。 BVS1.0 进行了支架设计以及生产技术的改进,得到
最近的 10 年里,血管支架的发展突飞猛进。各 了 BVS1.1[27,28],如图 2[29] 所示,图中黄色圆圈部分显
Color online
生率比较[33]
些都说明了 Absorb BVS 的晚期临床效果比第二代 Table 1 Comparison of device thrombosis among
DES 差,也印证了人们对于生物可吸收支架晚期临 BVS/EES/BMS (n=290)[33]
床效果不佳的担忧。从 Absorb II 的 1 和 3 a 的临床 Device thrombosis 30 d 1a
结果可以看出,2 组的心肌梗塞率随着随访时间的 BVS 2.1% 2.4%
延长而增加。BVS 组中面向器械的复合临床终点的 EES 0.3% 1.4%
涨幅明显比 DES 组的涨幅大,这也从侧面反映出对 BMS 1.0% 1.7%
于 DES 而言,BVS 手术成功率及适应性更低。更
Note: BVS—bioresorbable vascular stent, EES—
不可忽视的是,BVS 组中 3 a 临床结果显示共有 8
everolimus- eluting stent, BMS—bare metal
例确诊的支架内血栓形成,而作为对比,DES 组中 stent, n—quantity of patients
3 a 临床结果 显 示 没 有 支 架 内 血 栓 的 形 成 。 Ab-
sorb BVS 的长期安全性引起了人们的广泛关注, 表 2 Absorb AIDA 的 2 a 临床结果[34]
Table 2 Clinical outcomes after 2 a follow-up of Ab-
其难降解的高分子涂层以及较低的力学性能或
sorb AIDA trial[34]
许是导致 BVS 远期临床效果不佳的主要原因,也
Absorb AIDA BVS Co-Cr EES p
与患者过早停用双联抗血小板治疗有关 [32] 。另有
研究 [33] 表明 ,Absorb BVS 组中支架内血栓大多数 (n=924) (n=921)
表 4 可降解镁合金支架参数[3,49~51]
Table 4 Parameters of absorbable magnesium scaffolds[3,49~51]
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
图 4 扩张前后的可吸收镁合金支架[50]
Fig.4 Absorbable magnesium stent before (a) and after (b) expansion[50]
10 期 张小农等:医用可降解血管支架临床研究进展 1221
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]
Fig.5 Angiographic results of proximal right coronary artery before (a) and after (b) implantation of AMS[49]
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]
Fig.6 Angiography and intravascular ultrasound of proximal right coronary artery after post- procedure (a)
and 4 months follow-up (b)[49]
1222 金 属 学 报 53 卷
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]
Fig.7 Device functionality of drug-eluting absorbable magnesium scaffold over time[24]
10 期 张小农等:医用可降解血管支架临床研究进展 1223
表 5 BIOSOLVE 系列临床实验病变参数[50,51]
Table 5 Parameters of lesions in BIOSOLVE serial clinical trials[50,51]
表 6 可降解镁合金支架临床数据对比[49~51]
Table 6 Comparisons of clinical outcomes among absorbable magnesium scaffolds[49~51]
Note: LLL—late lumen loss, DS—diameter stenosis, MLD—minimum lumen diameter, TLR—target lesion revascularization,
NA—not available
图 10 可降解镁合金支架累计晚期管腔丢失对比[51]
Fig.10 Comparisons of cumulative frequency curves for late lumen loss among absorbable magnesium scaf-
folds[51]
(a) in-segment late lumen loss
(b) in-scaffold late lumen loss
(c) in segment late lumen loss by comparison among 3 absorbable magnesium scaffolds
(d) in scaffold late lumen loss by comparison among 3 absorbable magnesium scaffolds
多,新生内膜面积减少,晚期管腔丢失降低,这说 脱支架的各项临床效果良好,可有效满足大多数心
明负载抗增生药物对于血管支架来说是必不可少 血管疾病患者的需求。生物可吸收高分子支架较差
的,对于未来各种新型支架的研发有着重要的指导 的力学性能及远期临床效果决定了其短时间内很难
意义 [50,51]。相对于 DREAMS-1G 而言,DREAMS-2G 替代药物洗脱支架成为国内外临床使用的主流支
有更好的灵活性、更高的径向强度、更强的支架主干 架,必须通过改进以下 2 点,高分子支架才能获得更
设计以及更高的弯曲活性,整体临床效果更佳。由 长远的发展:第一,必须解决高分子力学性能差、弹
于晚期管腔丢失较小,故 BIOSOLVE-II 的患者 6 个 性回缩高和力学衰减快的缺陷;第二,减小高分子支
月随访的最小管腔面积也比 PROGRESS-AMS 及 架的厚度,加快高分子支架吸收速率,防止高分子长
BIOSOLVE-I 临床实验患者的最小管腔面积大很 时间遗留引起的超敏反应。
多。最值得关注的是,3 款生物可降解镁合金支架 通过生物可降解镁合金支架的更新迭代,其各
的临床随访均未发现支架内血栓事件的发生,这对 方面性能及临床效果已经越来越接近理想支架的要
于可降解镁合金支架的远期发展及应用有着重要的 求,发展潜力巨大,这对于可降解镁合金支架的远期
意义。但 DREAMS 存在一个安全隐患,BVS 相对于 发展及应用有着重要的意义。但可降解镁合金支架
DES 而言,因为存在生物标记物导致非 Q 波心肌梗 的系列临床实验都是小规模、简单病变的随机实验,
死的发生率更高,从而导致心梗死率大大提高[30,55]。 得到的临床数据不足以说明可降解镁合金支架可以
DREAMS 和 BVS 都同样具有生物标记物,是否也 适应各类病变患者,也无法证明其具备良好的远期
会产生同样的问题,还需要更多的随机临床实验去 临床效果,这需要更大规模、更复杂病变的长期临床
验证。 随机实验结果去验证。
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4 总结与展望
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