The Research progress of biodegradable magnesium alloy scaffolds at home and abroad

doi:10.3877/cma.j.issn.2095-5782.2020.01.016

Abstract

Abstract:

In recent years, much progress has been made on the territory of biodegradable magnesium alloy scaffolds in Vascular system. As a biodegradable material, magnesium alloy scaffolds has certain advantages over iron base alloy and zinc base alloy. The degradation of magnesium is too rapid to match the rates of tissue healing and it exhibits the non-uniform corrosion mechanism.Therefore, researchers optimized the bimetallic properties of biodegradable magnesium alloy scaffolds from the surface modification, forging process and composition ratio. And scaffolds were applied to preclinical experiments and clinical research. This review focuses on the following topics: the development history at home and abroad and the characteristics of biodegradable magnesium alloy scaffolds. Furthermore, this review also covers research carried out in the field of development prospect of the stent.

Key words: Bioresorbable scaffold, Biodegradable magnesium alloy scaffold, In-stent restenosis, Biodegradation

Linghua Kong, Yingkun He, Tianxiao Li, Yilin Zhang, Yanyan He, Shijie Zhu, Shaokang Guan. The Research progress of biodegradable magnesium alloy scaffolds at home and abroad[J]. Chinese Journal of Interventional Radiology(Electronic Edition), 2020, 08(01): 83-88.

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References 44

[1]	Cournand A F. Control of the pulmonary circulation in man with some remarks on methodology[J]. Nobel lecture, 1956: 531.
[2]	Sigwart U, Puel J, Mirkovitch V, et al. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty[J]. N Engl J Med. 1987, 316(12): 701-706.
[3]	Lange C, Storkebaum E, De Almodóvar C R, et al. Vascular endothelial growth factor: a neurovascular target in neurological diseases[J]. Nat Rev Neurol, 2016, 12(8): 439.
[4]	Nishio S, Kosuga K, Igaki K, et al. Long-term (> 10 years) clinical outcomes of first-in-human biodegradable poly-l-lactic acid coronary stents: Igaki-Tamai stents[J]. Circulation, 2012, 125(19): 2343-2353.
[5]	Dehghani P. Bioresorbable Polymers and Stent Devices[J].Curr Treat Options Cardiovasc Med, 2017, 19(2): 12.
[6]	Ali Z A, Gao R, Kimura T, et al. Three-year outcomes with the absorb bioresorbable scaffold: individual-patient-data meta-analysis from the ABSORB randomized trials[J]. Circulation, 2018, 137(5): 464-479.
[7]	Ellis S G, Kereiakes D J, Metzger D C, et al. Everolimus-eluting bioresorbable scaffolds for coronary artery disease[J]. N Engl J Med, 2015, 373(20): 1905-1915.
[8]	Kimura T, Kozuma K, Tanabe K, et al. A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds vs. everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan[J]. Eur Heart J, 2015, 36(47): 3332-3342.
[9]	Sabaté M, Windecker S, Iñiguez A, et al. Everolimus-eluting bioresorbable stent vs. durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction: results of the randomized ABSORB ST-segment elevation myocardial infarction—TROFI II trial[J]. Eur Heart J, 2015, 37(3): 229-240.
[10]	Gao R, Yang Y, Han Y, et al. Bioresorbable vascular scaffolds versus metallic stents in patients with coronary artery disease: ABSORB China trial[J]. J Am Coll Cardiol, 2015, 66(21): 2298-2309.
[11]	Arroyo D, Gendre G, Schukraft S, et al. Comparison of everolimus-and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds: two-year clinical outcomes of the EVERBIO II trial[J]. Int J Cardiol, 2017, 243: 121-125.
[12]	Serruys P W, Chevalier B, Dudek D, et al. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial[J]. The Lancet, 2015, 385(9962): 43-54.
[13]	Stone G W, Abizaid A, Onuma Y, et al. Effect of technique on outcomes following bioresorbable vascular scaffold implantation: analysis from the ABSORB trials[J]. J Am Coll Cardiol, 2017, 70(23): 2863-2874.
[14]	Stone G W, Granada J F. Very late thrombosis after bioresorbable scaffolds: cause for concern?[J]. J Am Coll Cardiol. 2015, 66(17):1915-1917.
[15]	甘佼弘，马晶，崔志琼，等. 生物可降解镁合金的全身毒性试验[J]. 中国老年学杂志，2018, 38(16): 4002-4005.
[16]	Gu X, Mao Z, Ye S H, et al. Biodegradable, elastomeric coatings with controlled anti-proliferative agent release for magnesium-based cardiovascular stents[J]. Colloids Surf B Biointerfaces, 2016, 144: 170-179..
[17]	Heublein B, Rohde R, Kaese V, et al. Biocorrosion of magnesium alloys: a new principle in cardiovascular implant technology?[J]. Heart, 2003, 89(6): 651-656.
[18]	Di Mario C, Griffiths H U W, Goktekin O, et al. Drug-eluting bioabsorbable magnesium stent[J].J Interv Cardiol, 2004, 17(6): 391-395.
[19]	Campos C, Muramatsu T, Iqbal J, et al. Bioresorbable drug-eluting magnesium-alloy scaffold for treatment of coronary artery disease[J]. Int J Mol Sci, 2013, 14(12): 24492-24500.
[20]	Rapetto C, Leoncini M. Magmaris: a new generation metallic sirolimus-eluting fully bioresorbable scaffold: present status and future perspectives[J]. J Thorac Dis, 2017, 9(Suppl 9): S903.
[21]	Lasala J M, Cox D A, Dobies D, et al. Drug-eluting stent thrombosis in routine clinical practice: two-year outcomes and predictors from the TAXUS ARRIVE registries[J]. Circ Cardiovasc Interv, 2009, 2(4): 285-293.
[22]	Juwana YB, Rasoul S, Ottervanger JP, et al. Efficacy and safety of rapamycin as compared to paclitaxel-eluting stents: a meta-analysis[J]. J Invasive Cardiol. 2010, 22(7):312-316.
[23]	Grube E, Silber S, Hauptmann K E, et al. TAXUS I: six-and twelve-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions[J]. Circulation, 2003, 107(1): 38-42.
[24]	Wittchow E, Adden N, Riedmüller J, et al. Bioresorbable drug-eluting magnesium-alloy scaffold: design and feasibility in a porcine coronary model[J]. EuroIntervention, 2013, 8(12): 1441-1450.
[25]	Haude M, Erbel R, Erne P, et al. Safety and performance of the drug-eluting absorbable metal scaffold (DREAMS) in patients with de-novo coronary lesions: 12 month results of the prospective, multicentre, first-in-man BIOSOLVE-I trial[J]. The Lancet, 2013, 381(9869): 836-844.
[26]	Haude M, Erbel R, Erne P, et al. 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[J]. EuroIntervention, 2016, 12: e160-6.
[27]	Haude M, Ince H, Tölg R, et al. Sustained safety and performance of the second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) in patients with de novo coronary lesions: 3-year clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial[J]. EuroIntervention, 2019, EIJ-D-18-01000.
[28]	Verheye S, Wlodarczak A, Montorsi P, et al. Safety and performance of a resorbable magnesium scaffold under real-world conditions: 12-month outcomes of the first 400 patients enrolled in the BIOSOLVE-IV registry[J]. EuroIntervention, 2019, EIJ-D-18-01058.
[29]	Felix C M, Vlachojannis G J, IJsselmuiden A J J, et al. Potentially increased incidence of scaffold thrombosis in patients treated with Absorb BVS who terminated DAPT before 18 months[J]. EuroIntervention, 2017, 13(2): e177-e184.
[30]	Chen C, Chen J, Wu W, et al. In vivo and in vitro evaluation of a biodegradable magnesium vascular stent designed by shape optimization strategy[J]. Biomaterials, 2019, 221: 119414.
[31]	Zhang X, Yuan G, Niu J, et al. Microstructure, mechanical properties, biocorrosion behavior, and cytotoxicity of as-extruded Mg-Nd-Zn-Zr alloy with different extrusion ratios[J]. J Mech Behav Biomed Mater, 2012, 9:153-162.
[32]	Mao L, Yuan G, Niu J, et al. In vitro degradation behavior and biocompatibility of Mg-Nd-Zn-Zr alloy by hydrofluoric acid treatment[J]. Mater Sci Eng C Mater Biol Appl, 2013, 33(1): 242-250.
[33]	Niu J, Yuan G, Liao Y, et al. Enhanced biocorrosion resistance and biocompatibility of degradable Mg-Nd-Zn-Zr alloy by brushite coating[J]. Mater Sci Eng C Mater Biol Appl, 2013, 33(8): 4833-4841.
[34]	Shi Y, Zhang L, Chen J, et al. In vitro and in vivo degradation of rapamycin-eluting Mg-Nd-Zn-Zr alloy stents in porcine coronary arteries[J]. Mater Sci Eng C Mater Biol Appl, 2017, 80: 1-6.
[35]	Mao L, Chen J, Zhang X, et al. A promising biodegradable magnesium alloy suitable for clinical vascular stent application[J]. Sci Rep, 2017, 7: 46343.
[36]	关绍康，王俊，王利国，等. 一种可生物降解血管支架用Mg-Zn-Y-Nd镁合金及其制备方法[P].中国专利，201110043303.8, 2011：
[37]	Wu Q, Zhu S, Wang L, et al. The microstructure and properties of cyclic extrusion compression treated Mg-Zn-Y-Nd alloy for vascular stent application[J]. J Mech Behav Biomed Mater, 2012, 8: 1-7.
[38]	Liu J, Zheng B, Wang P, et al. Enhanced in vitro and in vivo performance of Mg-Zn-Y-Nd alloy achieved with APTES pretreatment for drug-eluting vascular stent application[J]. ACS Appl Mater Interfaces. 2016, 8(28): 17842-17858.
[39]	Liu J, Wang P, Chu C C, et al. Arginine-leucine based poly (ester urea urethane) coating for Mg-Zn-Y-Nd alloy in cardiovascular stent applications[J]. Colloids Surf B Biointerfaces, 2017, 159: 78-88.
[40]	Wlodarczak A, Garcia L A I, Karjalainen P P, et al. Magnesium 2000 postmarket evaluation: Guideline adherence and intraprocedural performance of a sirolimus-eluting resorbable magnesium scaffold[J]. Cardiovasc Revasc Med, 2019, 20(12): 1140-1145.
[41]	贺迎坤，李天晓，王子亮，等．非急性期颅内椎基底动脉闭塞介入再通的中长期随访研究[J].中华放射学杂志，2017, 51(2): 145-148.
[42]	张一林，贺迎坤，李天晓，等. 涂布介入器械的人血管内皮生长因子真核表达载体的构建[J]. 中华介入放射学电子杂志，2019, 7(1): 40-43.
[43]	Gu X N, Zheng Y F. A review on magnesium alloys as biodegradable materials[J]. Front Mater Sci, 2010, 4(2): 111-115.
[44]	Esmaily M, Svensson J E, Fajardo S, et al. Fundamentals and advances in magnesium alloy corrosion[J]. Prog Mater Sci, 2017, 89: 92-19

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