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玛格玛瑞斯:新一代金属西罗莫司洗脱全生物可吸收支架:现状与未来展望

Magmaris: a new generation metallic sirolimus-eluting fully bioresorbable scaffold: present status and future perspectives.

作者信息

Rapetto Claudio, Leoncini Massimo

机构信息

S.S.D. Cardiologia Invasiva Endovascolare Sanremo, Sanremo, Italy.

出版信息

J Thorac Dis. 2017 Aug;9(Suppl 9):S903-S913. doi: 10.21037/jtd.2017.06.34.

DOI:10.21037/jtd.2017.06.34
PMID:28894596
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5583079/
Abstract

Drug-eluting stents (DES) have reached a high safety and efficacy profile, becoming the best option for percutaneous coronary interventions (PCI) based revascularization. However, despite their optimal performance, a few concerns remain regarding their use, mainly due to permanent caging of the vessels and its consequences, first of all late stent thrombosis (ST). Bioresorbable scaffolds (BRS) aim to overcome these issues. The results achieved in randomized controlled trials (RCT) by the first generation of poly-L-lactic acid (PLLA) based scaffolds were promising at 1 year, but the first long term reports (albeit flawed by non-optimal implantation technique) have been disappointing, showing, for instance, an increased risk of ST and target vessel myocardial infarction (TV-MI). In such a scenario the advent of a newer generation magnesium (Mg) based BRS is welcome, mainly because of its innovative mechanical and chemical features coupled with well proven biocompatibility. Despite being in its infancy, this technology seems to promise a great potential. In our article, we review the Magmaris (Biotronik AG, Bülach, Switzerland) Mg BRS development from animal models to human use, underscore its best qualities and weaknesses, and provide hints of its possible future perspectives.

摘要

药物洗脱支架(DES)已达到较高的安全性和有效性,成为经皮冠状动脉介入治疗(PCI)为基础的血运重建的最佳选择。然而,尽管其性能最佳,但在其使用方面仍存在一些问题,主要是由于血管的永久性支架植入及其后果,首先是晚期支架血栓形成(ST)。生物可吸收支架(BRS)旨在克服这些问题。第一代基于聚-L-乳酸(PLLA)的支架在随机对照试验(RCT)中1年时取得的结果很有前景,但首批长期报告(尽管因植入技术不理想而存在缺陷)却令人失望,例如显示出ST和靶血管心肌梗死(TV-MI)风险增加。在这种情况下,新一代基于镁(Mg)的BRS的出现是受欢迎的,主要是因为其创新的机械和化学特性以及已得到充分证实的生物相容性。尽管这项技术尚处于起步阶段,但似乎有很大的潜力。在我们的文章中,我们回顾了Magmaris(百多力公司,瑞士比拉赫)镁基BRS从动物模型到人体应用的发展历程,强调其优点和缺点,并对其可能的未来前景提供一些提示。

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本文引用的文献

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Second-generation magnesium scaffold Magmaris: device design and preclinical evaluation in a porcine coronary artery model.第二代镁支架 Magmaris:在猪冠状动脉模型中的器械设计和临床前评估。
EuroIntervention. 2017 Jul 20;13(4):440-449. doi: 10.4244/EIJ-D-16-00915.
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Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II): a 3 year, randomised, controlled, single-blind, multicentre clinical trial.对比依维莫司洗脱生物可吸收支架与依维莫司洗脱金属支架治疗冠状动脉狭窄的疗效(ABSORB II):3 年随机、对照、单盲、多中心临床试验。
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Possible mechanical causes of scaffold thrombosis: insights from case reports with intracoronary imaging.支架内血栓形成的可能机械原因:冠状动脉内影像学病例报告的启示。
EuroIntervention. 2017 Feb 20;12(14):1747-1756. doi: 10.4244/EIJ-D-16-00471.
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Magmaris preliminary recommendation upon commercial launch: a consensus from the expert panel on 14 April 2016.玛格玛瑞斯商业推出时的初步建议:2016年4月14日专家小组达成的共识。
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Safety and performance of the DRug-Eluting Absorbable Metal Scaffold (DREAMS) in patients with de novo coronary lesions: 3-year results of the prospective, multicentre, first-in-man BIOSOLVE-I trial.药物洗脱可吸收金属支架(DREAMS)在初发冠状动脉病变患者中的安全性和性能:前瞻性、多中心、人体首例BIOSOLVE-I试验的3年结果
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In vitro performance investigation of bioresorbable scaffolds - Standard tests for vascular stents and beyond.生物可吸收支架的体外性能研究——血管支架及其他领域的标准测试
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Sustained safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de novo coronary lesions: 12-month clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial.第二代药物洗脱可吸收金属支架在初发冠状动脉病变患者中的持续安全性和性能:BIOSOLVE-II首次人体试验的12个月临床结果和血管造影结果
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Bioresorbable Coronary Scaffold Thrombosis: Multicenter Comprehensive Analysis of Clinical Presentation, Mechanisms, and Predictors.生物可吸收冠状动脉支架血栓形成:多中心临床特征、机制和预测因素的综合分析。
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1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis.冠心病患者应用 Absorb 生物可吸收支架的 1 年结果:一项患者水平的汇总荟萃分析。
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Scaffold Thrombosis After Percutaneous Coronary Intervention With ABSORB Bioresorbable Vascular Scaffold: A Systematic Review and Meta-Analysis.经皮冠状动脉介入治疗后 ABSORB 生物可吸收血管支架内血栓形成:系统评价和荟萃分析。
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