Research progress of coronary bioabsorbable metal stents_West China Medical Journal

Authors：

HUANG Yu ^1,2 , MENG Chen ^1,2 , HU Shuyi ^1,2 , TIAN Wei ¹ ,  ZHU Handong ¹

1. Department of Cardiology, Wuhan Asia Heart Hospital Affiliated to Wuhan University of Science and Technology, Wuhan, Hubei 430022, P. R. China;
2. Medical College, Medical Department, Wuhan University of Science and Technology, Wuhan, Hubei 430065, P. R. China;

Corresponding author：

ZHU Handong, Email: zhuhandong_JP603@126.com

Keywords：

Bioabsorbable metal stents; bioresorbable metal coating; nano coating

DOI：

10.7507/1002-0179.202412227

Video：

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Coronary stents have been improved in materials, design, coating and antiproliferative drugs in many aspects, but at present, coronary stents still have long-term chronic inflammatory reaction and new atherosclerosis, leading to coronary vasomotor dysfunction, thrombosis and restenosis. In order to address the limitations of current coronary stents, the latest preclinical and clinical studies have evaluated the feasibility of novel bioabsorbable metal stents, including novel bioabsorbable alloys and novel bioabsorbable metal coatings. The purpose of this article is to summarize the latest research results on coronary bioabsorbable metal stents and provide a reference for the clinical application.

1.	Zhang Y, Roux C, Rouchaud A, et al. Recent advances in Fe-based bioresorbable stents: materials design and biosafety. Bioact Mater, 2023, 31: 333-354.
2.	Ahadi F, Azadi M, Biglari M, et al. Evaluation of coronary stents: a review of types, materials, processing techniques, design, and problems. Heliyon, 2023, 9(2): e13575.
3.	Koźlik M, Harpula J, Chuchra PJ, et al. Drug-eluting stents: technical and clinical progress. Biomimetics (Basel), 2023, 8(1): 72.
4.	Tsai ML, Hsieh MJ, Chen CC, et al. Comparison of 9-month angiographic follow-up and long-term clinical outcomes of biodegradable polymer drug-eluting stents and second-generation durable polymer drug-eluting stents in patients undergoing single coronary artery stenting. Acta Cardiol Sin, 2020, 36(2): 97-104.
5.	Torii S, Jinnouchi H, Sakamoto A, et al. Drug-eluting coronary stents: insights from preclinical and pathology studies. Nat Rev Cardiol, 2020, 17(1): 37-51.
6.	Sambola A, Rello P, Soriano T, et al. Safety and efficacy of drug eluting stents vs bare metal stents in patients with atrial fibrillation: a systematic review and meta-analysis. Thromb Res, 2020, 195: 128-135.
7.	Stone GW, Kereiakes DJ, Gori T, et al. 5-year outcomes after bioresorbable coronary scaffolds implanted with improved technique. J Am Coll Cardiol, 2023, 82(3): 183-195.
8.	Song L, Guan C, Yu M, et al. Sirolimus-eluting iron bioresorbable scaffold versus cobalt-chromium everolimus-eluting stents in patients with coronary artery disease: rationale and design of the IRONMAN-II trial. Am Heart J, 2024, 275: 53-61.
9.	Wang Z, Song J, Peng Y. New insights and perspectives into biodegradable metals in cardiovascular stents: a mini review. J Alloy Compd, 2024, 1002(8): 175313.
10.	Seth A, Onuma Y, Chandra P, et al. Three-year clinical and two-year multimodality imaging outcomes of a thin-strut sirolimus-eluting bioresorbable vascular scaffold: MeRes-1 trial. EuroIntervention, 2019, 15(7): 607-614.
11.	Lutz M, Abizaid A, Nielsen Holck E, et al. Long-term safety and effectiveness of the Fantom bioresorbable coronary artery scaffold: final results of the FANTOM II trial. EuroIntervention, 2024, 20(7): e453-e456.
12.	Wang X, Li Y, Fu G, et al. Three-year clinical outcomes of the novel sirolimus-eluting bioresorbable scaffold for the treatment of de novo coronary artery disease: a prospective patient-level pooled analysis of NeoVas trials. Catheter Cardiovasc Interv, 2023, 101(6): 967-972.
13.	Song L, Xu B, Chen Y, et al. Thinner strut sirolimus-eluting BRS versus EES in patients with coronary artery disease: FUTURE-II trial. JACC Cardiovasc Interv, 2021, 14(13): 1450-1462.
14.	Ferdous MM, Jie Z, Gao L, et al. A first-in-human study of the bioheart sirolimus-eluting bioresorbable vascular scaffold in patients with coronary artery disease: two-year clinical and imaging outcomes. Adv Ther, 2022, 39(8): 3749-3765.
15.	Oliver AA, Sikora-Jasinska M, Demir AG, et al. Recent advances and directions in the development of bioresorbable metallic cardiovascular stents: insights from recent human and in vivo studies. Acta Biomater, 2021, 127: 1-23.
16.	Shen D, Qi H, Lin W, et al. PDLLA-Zn-nitrided Fe bioresorbable scaffold with 53-μm-thick metallic struts and tunable multistage biodegradation function. Sci Adv, 2021, 7(23): eabf0614.
17.	Wlodarczak A, Montorsi P, Torzewski J, et al. One- and two-year clinical outcomes of treatment with resorbable magnesium scaffolds for coronary artery disease: the prospective, international, multicentre BIOSOLVE-IV registry. EuroIntervention, 2023, 19(3): 232-239.
18.	Fu J, Su Y, Qin YX, et al. Evolution of metallic cardiovascular stent materials: a comparative study among stainless steel, magnesium and zinc. Biomaterials, 2020, 230: 119641.
19.	Zhang ZQ, Yang YX, Li JA, et al. Advances in coatings on magnesium alloys for cardiovascular stents - a review. Bioact Mater, 2021, 6(12): 4729-4757.
20.	Seetharaman S, Sankaranarayanan D, Gupta M. Magnesium-based temporary implants: potential, current status, applications, and challenges. J Funct Biomater, 2023, 14(6): 324.
21.	Harawaza K, Cousins B, Roach P, et al. Modification of the surface nanotopography of implant devices: a translational perspective. Mater Today Bio, 2021, 12: 100152.
22.	Zhu J, Zhang X, Niu J, et al. Biosafety and efficacy evaluation of a biodegradable magnesium-based drug-eluting stent in porcine coronary artery. Sci Rep, 2021, 11(1): 7330.
23.	Haude M, Wlodarczak A, van der Schaaf RJ, et al. A new resorbable magnesium scaffold for de novo coronary lesions (DREAMS 3): one-year results of the BIOMAG-I first-in-human study. EuroIntervention, 2023, 19(5): e414-e422.
24.	Deng Y, Huang J, Chen C, et al. Fe₃O₄ coated stent prevent artery neointimal hyperplasia by inhibiting vascular smooth muscle cell proliferation. Mater Today Bio, 2024, 27: 101133.
25.	Zheng JF, Xi ZW, Li Y, et al. Long-term safety and absorption assessment of a novel bioresorbable nitrided iron scaffold in porcine coronary artery. Bioact Mater, 2022, 17: 496-505.
26.	Gao RL, Xu B, Sun Z, et al. First-in-human evaluation of a novel ultrathin sirolimus-eluting iron bioresorbable scaffold: 3-year outcomes of the IBS-FIM trial. EuroIntervention, 2023, 19(3): 222-231.
27.	Roman AM, Cimpoeșu R, Pricop B, et al. Investigations on the degradation behavior of processed FeMnSi-xCu shape memory alloys. Nanomaterials (Basel), 2024, 14(4): 330.
28.	Chen L, Guo Y, Chen L, et al. Injectable Zn²⁺ and paeoniflorin release hydrogel for promoting wound healing. ACS Appl Bio Mater, 2023, 6(6): 2184-2195.
29.	Mostaed E, Sikora-Jasinska M, Ardakani MS, et al. Towards revealing key factors in mechanical instability of bioabsorbable Zn-based alloys for intended vascular stenting. Acta Biomater, 2020, 105: 319-335.
30.	钱漪, 袁广银. 可降解锌合金血管支架的研究现状、面临的挑战与对策思考. 金属学报, 2021, 57(3): 272-282.
31.	袁广银. 新型全降解锌合金血管支架研发及其临床应用基础研究. 科技成果管理与研究, 2022, 17(12): 63-66.
32.	Lin S, Ran X, Yan X, et al. Corrosion behavior and biocompatibility evaluation of a novel zinc-based alloy stent in rabbit carotid artery model. J Biomed Mater Res B Appl Biomater, 2019, 107(6): 1814-1823.
33.	Jiang J, Qian Y, Huang H, et al. Biodegradable Zn-Cu-Mn alloy with suitable mechanical performance and in vitro degradation behavior as a promising candidate for vascular stents. Biomater Adv, 2022, 133: 112652.
34.	Zhang X, Niu J, Yeung KW, et al. Developing Zn-2Cu-xLi (x<0.1wt%) alloys with suitable mechanical properties, degradation behaviors and cytocompatibility for vascular stents. Acta Biomater, 2024, 12: S1742-7061(24)00313-1.
35.	Zeng Y, Guan Z, Linsley CS, et al. Experimental study on novel biodegradable Zn-Fe-Si alloys. J Biomed Mater Res B Appl Biomater, 2022, 110(10): 2266-2275.
36.	Guan Z, Linsley CS, Pan S, et al. Zn-Mg-WC nanocomposites for bioresorbable cardiovascular stents: microstructure, mechanical properties, fatigue, shelf life, and corrosion. ACS Biomater Sci Eng, 2022, 8(1): 328-339.
37.	Yang H, Jin D, Rao J, et al. Lithium-induced optimization mechanism for an ultrathin-strut biodegradable Zn-based vascular scaffold. Adv Mater, 2023, 35(19): e2301074.
38.	Guillory RJ 2nd, Mostaed E, Oliver AA, et al. Improved biocompatibility of Zn-Ag-based stent materials by microstructure refinement. Acta Biomater, 2022, 145: 416-426.
39.	Dou Z, Chen S, Wang J, et al. A “built-up” composite film with synergistic functionalities on Mg-2Zn-1Mn bioresorbable stents improves corrosion control effects and biocompatibility. Bioact Mater, 2023, 25: 223-238.
40.	Pan K, Zhang W, Shi H, et al. Zinc Ion-crosslinked polycarbonate/heparin composite coatings for biodegradable Zn-alloy stent applications. Colloids Surf B Biointerfaces, 2022, 218: 112725.
41.	Toong DWY, Toh HW, Ng JCK, et al. Bioresorbable polymeric scaffold in cardiovascular applications. Int J Mol Sci, 2020, 21(10): 3444.
42.	Li L, Soyhan I, Warszawik E, et al. Layered double hydroxides: recent progress and promising perspectives toward biomedical applications. Adv Sci (Weinh), 2024, 11(20): e2306035.
43.	Zong J, He Q, Liu Y, et al. Advances in the development of biodegradable coronary stents: a translational perspective. Mater Today Bio, 2022, 16: 100368.
44.	Li D, Dai D, Xiong G, et al. Composite nanocoatings of biomedical magnesium alloy implants: advantages, mechanisms, and design strategies. Adv Sci (Weinh), 2023, 10(18): e2300658.
45.	Bian J, Yang R, Wang D, et al. Evaluation of the safety and efficacy of a polyzene-F nanocoated coronary stent system: a systematic review and single-arm meta-analysis. Front Cardiovasc Med, 2023, 10: 1095794.
46.	Singh N, Kulkarni PP, Tripathi P, et al. Nanogold-coated stent facilitated non-invasive photothermal ablation of stent thrombosis and restoration of blood flow. Nanoscale Adv, 2024, 6(5): 1497-1506.
47.	Jiang W, Zhao W, Zhou T, et al. A review on manufacturing and post-processing technology of vascular stents. Micromachines (Basel), 2022, 13(1): 140.
48.	Kianifar M, Azadi M, Heidari F. Evaluation of stress-controlled high-cycle fatigue characteristics in PLA-wood fused deposition modeling 3D-printed parts under bending loads. PLoS One, 2024, 19(4): e0300569.
49.	Wang Y, Venezuela J, Dargusch M. Biodegradable shape memory alloys: progress and prospects. Biomaterials, 2021, 279: 121215.
50.	Ryu H, Seo MH, Rogers JA. Bioresorbable metals for biomedical applications: from mechanical components to electronic devices. Adv Healthc Mater, 2021, 10(17): e2002236.
51.	Son D, Lee J, Lee DJ, et al. Bioresorbable electronic stent integrated with therapeutic nanoparticles for endovascular diseases. ACS Nano, 2015, 9(6): 5937-5946.

1. Zhang Y, Roux C, Rouchaud A, et al. Recent advances in Fe-based bioresorbable stents: materials design and biosafety. Bioact Mater, 2023, 31: 333-354.
2. Ahadi F, Azadi M, Biglari M, et al. Evaluation of coronary stents: a review of types, materials, processing techniques, design, and problems. Heliyon, 2023, 9(2): e13575.
3. Koźlik M, Harpula J, Chuchra PJ, et al. Drug-eluting stents: technical and clinical progress. Biomimetics (Basel), 2023, 8(1): 72.
4. Tsai ML, Hsieh MJ, Chen CC, et al. Comparison of 9-month angiographic follow-up and long-term clinical outcomes of biodegradable polymer drug-eluting stents and second-generation durable polymer drug-eluting stents in patients undergoing single coronary artery stenting. Acta Cardiol Sin, 2020, 36(2): 97-104.
5. Torii S, Jinnouchi H, Sakamoto A, et al. Drug-eluting coronary stents: insights from preclinical and pathology studies. Nat Rev Cardiol, 2020, 17(1): 37-51.
6. Sambola A, Rello P, Soriano T, et al. Safety and efficacy of drug eluting stents vs bare metal stents in patients with atrial fibrillation: a systematic review and meta-analysis. Thromb Res, 2020, 195: 128-135.
7. Stone GW, Kereiakes DJ, Gori T, et al. 5-year outcomes after bioresorbable coronary scaffolds implanted with improved technique. J Am Coll Cardiol, 2023, 82(3): 183-195.
8. Song L, Guan C, Yu M, et al. Sirolimus-eluting iron bioresorbable scaffold versus cobalt-chromium everolimus-eluting stents in patients with coronary artery disease: rationale and design of the IRONMAN-II trial. Am Heart J, 2024, 275: 53-61.
9. Wang Z, Song J, Peng Y. New insights and perspectives into biodegradable metals in cardiovascular stents: a mini review. J Alloy Compd, 2024, 1002(8): 175313.
10. Seth A, Onuma Y, Chandra P, et al. Three-year clinical and two-year multimodality imaging outcomes of a thin-strut sirolimus-eluting bioresorbable vascular scaffold: MeRes-1 trial. EuroIntervention, 2019, 15(7): 607-614.
11. Lutz M, Abizaid A, Nielsen Holck E, et al. Long-term safety and effectiveness of the Fantom bioresorbable coronary artery scaffold: final results of the FANTOM II trial. EuroIntervention, 2024, 20(7): e453-e456.
12. Wang X, Li Y, Fu G, et al. Three-year clinical outcomes of the novel sirolimus-eluting bioresorbable scaffold for the treatment of de novo coronary artery disease: a prospective patient-level pooled analysis of NeoVas trials. Catheter Cardiovasc Interv, 2023, 101(6): 967-972.
13. Song L, Xu B, Chen Y, et al. Thinner strut sirolimus-eluting BRS versus EES in patients with coronary artery disease: FUTURE-II trial. JACC Cardiovasc Interv, 2021, 14(13): 1450-1462.
14. Ferdous MM, Jie Z, Gao L, et al. A first-in-human study of the bioheart sirolimus-eluting bioresorbable vascular scaffold in patients with coronary artery disease: two-year clinical and imaging outcomes. Adv Ther, 2022, 39(8): 3749-3765.
15. Oliver AA, Sikora-Jasinska M, Demir AG, et al. Recent advances and directions in the development of bioresorbable metallic cardiovascular stents: insights from recent human and in vivo studies. Acta Biomater, 2021, 127: 1-23.
16. Shen D, Qi H, Lin W, et al. PDLLA-Zn-nitrided Fe bioresorbable scaffold with 53-μm-thick metallic struts and tunable multistage biodegradation function. Sci Adv, 2021, 7(23): eabf0614.
17. Wlodarczak A, Montorsi P, Torzewski J, et al. One- and two-year clinical outcomes of treatment with resorbable magnesium scaffolds for coronary artery disease: the prospective, international, multicentre BIOSOLVE-IV registry. EuroIntervention, 2023, 19(3): 232-239.
18. Fu J, Su Y, Qin YX, et al. Evolution of metallic cardiovascular stent materials: a comparative study among stainless steel, magnesium and zinc. Biomaterials, 2020, 230: 119641.
19. Zhang ZQ, Yang YX, Li JA, et al. Advances in coatings on magnesium alloys for cardiovascular stents - a review. Bioact Mater, 2021, 6(12): 4729-4757.
20. Seetharaman S, Sankaranarayanan D, Gupta M. Magnesium-based temporary implants: potential, current status, applications, and challenges. J Funct Biomater, 2023, 14(6): 324.
21. Harawaza K, Cousins B, Roach P, et al. Modification of the surface nanotopography of implant devices: a translational perspective. Mater Today Bio, 2021, 12: 100152.
22. Zhu J, Zhang X, Niu J, et al. Biosafety and efficacy evaluation of a biodegradable magnesium-based drug-eluting stent in porcine coronary artery. Sci Rep, 2021, 11(1): 7330.
23. Haude M, Wlodarczak A, van der Schaaf RJ, et al. A new resorbable magnesium scaffold for de novo coronary lesions (DREAMS 3): one-year results of the BIOMAG-I first-in-human study. EuroIntervention, 2023, 19(5): e414-e422.
24. Deng Y, Huang J, Chen C, et al. Fe₃O₄ coated stent prevent artery neointimal hyperplasia by inhibiting vascular smooth muscle cell proliferation. Mater Today Bio, 2024, 27: 101133.
25. Zheng JF, Xi ZW, Li Y, et al. Long-term safety and absorption assessment of a novel bioresorbable nitrided iron scaffold in porcine coronary artery. Bioact Mater, 2022, 17: 496-505.
26. Gao RL, Xu B, Sun Z, et al. First-in-human evaluation of a novel ultrathin sirolimus-eluting iron bioresorbable scaffold: 3-year outcomes of the IBS-FIM trial. EuroIntervention, 2023, 19(3): 222-231.
27. Roman AM, Cimpoeșu R, Pricop B, et al. Investigations on the degradation behavior of processed FeMnSi-xCu shape memory alloys. Nanomaterials (Basel), 2024, 14(4): 330.
28. Chen L, Guo Y, Chen L, et al. Injectable Zn²⁺ and paeoniflorin release hydrogel for promoting wound healing. ACS Appl Bio Mater, 2023, 6(6): 2184-2195.
29. Mostaed E, Sikora-Jasinska M, Ardakani MS, et al. Towards revealing key factors in mechanical instability of bioabsorbable Zn-based alloys for intended vascular stenting. Acta Biomater, 2020, 105: 319-335.
30. 钱漪, 袁广银. 可降解锌合金血管支架的研究现状、面临的挑战与对策思考. 金属学报, 2021, 57(3): 272-282.
31. 袁广银. 新型全降解锌合金血管支架研发及其临床应用基础研究. 科技成果管理与研究, 2022, 17(12): 63-66.
32. Lin S, Ran X, Yan X, et al. Corrosion behavior and biocompatibility evaluation of a novel zinc-based alloy stent in rabbit carotid artery model. J Biomed Mater Res B Appl Biomater, 2019, 107(6): 1814-1823.
33. Jiang J, Qian Y, Huang H, et al. Biodegradable Zn-Cu-Mn alloy with suitable mechanical performance and in vitro degradation behavior as a promising candidate for vascular stents. Biomater Adv, 2022, 133: 112652.
34. Zhang X, Niu J, Yeung KW, et al. Developing Zn-2Cu-xLi (x<0.1wt%) alloys with suitable mechanical properties, degradation behaviors and cytocompatibility for vascular stents. Acta Biomater, 2024, 12: S1742-7061(24)00313-1.
35. Zeng Y, Guan Z, Linsley CS, et al. Experimental study on novel biodegradable Zn-Fe-Si alloys. J Biomed Mater Res B Appl Biomater, 2022, 110(10): 2266-2275.
36. Guan Z, Linsley CS, Pan S, et al. Zn-Mg-WC nanocomposites for bioresorbable cardiovascular stents: microstructure, mechanical properties, fatigue, shelf life, and corrosion. ACS Biomater Sci Eng, 2022, 8(1): 328-339.
37. Yang H, Jin D, Rao J, et al. Lithium-induced optimization mechanism for an ultrathin-strut biodegradable Zn-based vascular scaffold. Adv Mater, 2023, 35(19): e2301074.
38. Guillory RJ 2nd, Mostaed E, Oliver AA, et al. Improved biocompatibility of Zn-Ag-based stent materials by microstructure refinement. Acta Biomater, 2022, 145: 416-426.
39. Dou Z, Chen S, Wang J, et al. A “built-up” composite film with synergistic functionalities on Mg-2Zn-1Mn bioresorbable stents improves corrosion control effects and biocompatibility. Bioact Mater, 2023, 25: 223-238.
40. Pan K, Zhang W, Shi H, et al. Zinc Ion-crosslinked polycarbonate/heparin composite coatings for biodegradable Zn-alloy stent applications. Colloids Surf B Biointerfaces, 2022, 218: 112725.
41. Toong DWY, Toh HW, Ng JCK, et al. Bioresorbable polymeric scaffold in cardiovascular applications. Int J Mol Sci, 2020, 21(10): 3444.
42. Li L, Soyhan I, Warszawik E, et al. Layered double hydroxides: recent progress and promising perspectives toward biomedical applications. Adv Sci (Weinh), 2024, 11(20): e2306035.
43. Zong J, He Q, Liu Y, et al. Advances in the development of biodegradable coronary stents: a translational perspective. Mater Today Bio, 2022, 16: 100368.
44. Li D, Dai D, Xiong G, et al. Composite nanocoatings of biomedical magnesium alloy implants: advantages, mechanisms, and design strategies. Adv Sci (Weinh), 2023, 10(18): e2300658.
45. Bian J, Yang R, Wang D, et al. Evaluation of the safety and efficacy of a polyzene-F nanocoated coronary stent system: a systematic review and single-arm meta-analysis. Front Cardiovasc Med, 2023, 10: 1095794.
46. Singh N, Kulkarni PP, Tripathi P, et al. Nanogold-coated stent facilitated non-invasive photothermal ablation of stent thrombosis and restoration of blood flow. Nanoscale Adv, 2024, 6(5): 1497-1506.
47. Jiang W, Zhao W, Zhou T, et al. A review on manufacturing and post-processing technology of vascular stents. Micromachines (Basel), 2022, 13(1): 140.
48. Kianifar M, Azadi M, Heidari F. Evaluation of stress-controlled high-cycle fatigue characteristics in PLA-wood fused deposition modeling 3D-printed parts under bending loads. PLoS One, 2024, 19(4): e0300569.
49. Wang Y, Venezuela J, Dargusch M. Biodegradable shape memory alloys: progress and prospects. Biomaterials, 2021, 279: 121215.
50. Ryu H, Seo MH, Rogers JA. Bioresorbable metals for biomedical applications: from mechanical components to electronic devices. Adv Healthc Mater, 2021, 10(17): e2002236.
51. Son D, Lee J, Lee DJ, et al. Bioresorbable electronic stent integrated with therapeutic nanoparticles for endovascular diseases. ACS Nano, 2015, 9(6): 5937-5946.

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