TCT 2020丨ILLUMENATE 研究:低剂量紫杉醇药物涂层球囊在股腘动脉病变中的四年研究结果

2020-11-06 心关注 心关注

药物涂层球囊(DCB)是用于症状性股腘动脉疾病的主要血运重建疗法。紫杉醇DCB短中期的疗效和安全性已经得到证实。然而,其长期疗效如何仍缺乏相关数据。

药物涂层球囊(DCB)是用于症状性股腘动脉疾病的主要血运重建疗法。紫杉醇DCB短中期的疗效和安全性已经得到证实。然而,其长期疗效如何仍缺乏相关数据。2020 TCT大会上公布了ILLUMENATE Global研究即低剂量药物涂层球囊治疗股腘动脉新生或再狭窄的4年随访结果,在更广泛人群中证明了Stellarex DCB的安全性和疗效。

专家点评

点评专家:程翔教授

医学博士,二级教授/主任医师,博士生导师,美国心脏病学会Fellow (FACC)。华中科技大学同济医学院附属协和医院血管内科主任,心研所副所长,教育部长江学者特聘教授,国家杰出青年基金获得者。主持国家自然科学基金8项。以通讯作者在Circulation, J Am Coll Cardiol, Eur Heart J等杂志发表SCI论文40余篇。获省科技进步一等奖一项和国家发明专利一项,参编《心血管内科学(第3版)》、《心脏病学》等专着。临床上擅长冠心病介入治疗和血脂异常的诊治。

外周血管疾病(PAD)作为一种常见疾病,若没有得到有效治疗,可能会导致慢性肢体缺血(CLI)[1],而CLI其关键的一个治疗缺口是对抑制再狭窄的满足。再狭窄通常在治疗后的3至6个月内发生,其可导致再次介入治疗以及截肢的发生率增加。DCB治疗支架内再狭窄(ISR)已得到了欧洲血运重建指南的Ⅰ类推荐。

ILLUMENATE系列研究包括了ILLUMENATE PK、FIH、Pivotal等研究,其中ILLUMENATE PK研究测量了末次DCB放置后和在规定的时间(1, 4, 24小时,手术后7和14天)紫杉醇血浆浓度,明确了DCB的药物动力学[2]。ILLUMENATE FIH则是一项前瞻性、多中心研究,旨在评估Stellarex DCB的安全性和疗效[2],该研究中纳入50例患者采用Stellarex DCB治疗,结果证实Stellarex DCB是安全的,效果可持续至24个月。ILLUMENATE Pivotal 研究则将纳入人群扩大至300名,再次证实了DCB对于股腘动脉再狭窄病变12个月内的安全性和疗效,但对DCB的更远期疗效和安全性缺乏相关证据[3]。ILLUMENATE Global研究是建立在以上研究的基础上,纳入了更多的人群,观察时间更长,虽数据仍在分析总结中,但4年随访的初步结果显示DCB具有长期良好的安全性和有效性,其结果与ILLUMENATE FIH和ILLUMENATE Pivotal研究一致,在糖尿病患者或复杂病变中也具有相似的疗效。

研究背景

ILLUMENATE Global研究是一项前瞻性、单臂、多中心研究,纳入的人群包括下肢动脉缺血Rutherford分级(RCC)在2-4级以及股浅动脉和/或腘动脉再狭窄需要接受治疗的患者,共计371名,其人群特点:平均年龄68.2±9.3岁,男性占比73%,平均BMI指数:27.0±4.3,其中患有糖尿病占比73%,患有高血压占比79.5%,患有高脂血症占比74.7%,有抽烟史占比81.9%,既往接受冠脉血运重建治疗占比33.4%,既往接受下肢血管介入治疗占比42.3%。纳入人群的血管造影基线特点:平均病变长度7.5±5.3(cm),病变存在严重钙化患者占比40.8%。

研究终点

该研究观察主要的安全终点是在30天内无器械和手术相关的死亡,并且在12个月内没有目标肢体截肢和临床症状驱动的目标病变血运重建(CD-TLR)。主要疗效终点是12个月内血管通畅程度,定义为无靶病灶的再狭窄(收缩峰值速度比≤2.5)。

研究结果

该研究显示随访4年后安全终点良好,目标肢体截肢发生率为0.8%,全因死亡率为8.1%,CD-TLR的发生率为21.8%。在观察截止到1460天,通过血管造影复查,没有发生再狭窄事件或者RCC分级好转至少1级以上的人群占比75.6%。并且人群以性别、病变长度或是否患有糖尿病进行分组,其安全终点和有效性无明显区别。

 

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    2020-11-19 liye789132251
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    2020-11-08 花花1366
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目前对冠状动脉支架内再狭窄的治疗方式有多种,那么什么才是最安全有效的办法?就该问题,研究者进行了分层贝叶斯模型下的网状meta分析。 通过检索PubMed、Embase、Scopus、Cochrane Library、Web of Science、ScienceDirect等数据库,纳入了关于冠状动脉支架内再狭窄(裸金属支架或药物洗脱支架:初发或复发)的随机对照试验。主要终点是在6到12个月

Lancet:药物涂层球囊用于新发冠状动脉小血管疾病的长期预后研究

通过3年的随访发现,对于新生冠状动脉小血管疾病患者,接受药物涂层球囊或药物洗脱支架的治疗效果和安全性相当

徐州三院张瑶俊等病例报告:药物涂层球囊治疗心梗有潜力

冠状动脉支架内再狭窄,是各大指南推荐应用药物涂层球囊(DCB)的Ia类指征,不过直接用于ST段抬高型心肌梗死(STEMI)这种特殊的冠脉原位原发病变效果如何?

EuroPCR2018丨陈韵岱&唐熠达:两项中国全新DEB RCT临床试验初放异彩!

2018年5月22~25日,欧洲经皮心血管介入治疗协会年会(EuroPCR 2018)于法国-巴黎盛大召开。众多中国心血管介入领域专家、学者远赴盛会,交流、探讨学术进展,我们注意到来自中国的RESTORE DEB CHINA系列研究,RESTORE ISR和RESTORE SVD均入选大会最新临床试验,由中国医学科学院阜外医院唐熠达教授代表研究学组汇报了研究的最新动态。

Lancet:小冠状动脉疾病的治疗——药物涂层球囊vs药物洗脱支架

研究认为,药物涂层球囊与药物洗脱支架相比治疗小冠状动脉疾病12个月的疗效和安全性差异不显著

Circ: Cardiovasc Inte:药物涂层球囊的治疗效果在股腘动脉中可持续3年

3年结果表明与标准PTA相比,使用DCB患者的治疗效果持久且优越,初次通畅率较高。