Corrosion behavior and biocompatibility evaluation of a novel zinc-based alloy stent in rabbit carotid artery model
Song Lin
Key Laboratory for Biorheological Science and Technology of Ministry of Education, State and Local Joint Engineering Laboratory for Vascular Implants, Bioengineering College of Chongqing University, Chongqing, 400030 China
Search for more papers by this authorXiaolin Ran
Key Laboratory for Biorheological Science and Technology of Ministry of Education, State and Local Joint Engineering Laboratory for Vascular Implants, Bioengineering College of Chongqing University, Chongqing, 400030 China
Search for more papers by this authorXinhao Yan
Xi'an Advanced Medical Technology Co., Ltd, Xi'an, 710000 China
Search for more papers by this authorWenhua Yan
Key Laboratory for Biorheological Science and Technology of Ministry of Education, State and Local Joint Engineering Laboratory for Vascular Implants, Bioengineering College of Chongqing University, Chongqing, 400030 China
Search for more papers by this authorQilong Wang
Key Laboratory for Biorheological Science and Technology of Ministry of Education, State and Local Joint Engineering Laboratory for Vascular Implants, Bioengineering College of Chongqing University, Chongqing, 400030 China
Search for more papers by this authorTieying Yin
Key Laboratory for Biorheological Science and Technology of Ministry of Education, State and Local Joint Engineering Laboratory for Vascular Implants, Bioengineering College of Chongqing University, Chongqing, 400030 China
Search for more papers by this authorJack G Zhou
Xi'an Advanced Medical Technology Co., Ltd, Xi'an, 710000 China
Search for more papers by this authorCorresponding Author
Tingzhang Hu
Key Laboratory for Biorheological Science and Technology of Ministry of Education, State and Local Joint Engineering Laboratory for Vascular Implants, Bioengineering College of Chongqing University, Chongqing, 400030 China
Correspondence to: G. Wang; e-mail: [email protected] or T. Hu; e-mail: [email protected]Search for more papers by this authorCorresponding Author
Guixue Wang
Key Laboratory for Biorheological Science and Technology of Ministry of Education, State and Local Joint Engineering Laboratory for Vascular Implants, Bioengineering College of Chongqing University, Chongqing, 400030 China
Correspondence to: G. Wang; e-mail: [email protected] or T. Hu; e-mail: [email protected]Search for more papers by this authorSong Lin
Key Laboratory for Biorheological Science and Technology of Ministry of Education, State and Local Joint Engineering Laboratory for Vascular Implants, Bioengineering College of Chongqing University, Chongqing, 400030 China
Search for more papers by this authorXiaolin Ran
Key Laboratory for Biorheological Science and Technology of Ministry of Education, State and Local Joint Engineering Laboratory for Vascular Implants, Bioengineering College of Chongqing University, Chongqing, 400030 China
Search for more papers by this authorXinhao Yan
Xi'an Advanced Medical Technology Co., Ltd, Xi'an, 710000 China
Search for more papers by this authorWenhua Yan
Key Laboratory for Biorheological Science and Technology of Ministry of Education, State and Local Joint Engineering Laboratory for Vascular Implants, Bioengineering College of Chongqing University, Chongqing, 400030 China
Search for more papers by this authorQilong Wang
Key Laboratory for Biorheological Science and Technology of Ministry of Education, State and Local Joint Engineering Laboratory for Vascular Implants, Bioengineering College of Chongqing University, Chongqing, 400030 China
Search for more papers by this authorTieying Yin
Key Laboratory for Biorheological Science and Technology of Ministry of Education, State and Local Joint Engineering Laboratory for Vascular Implants, Bioengineering College of Chongqing University, Chongqing, 400030 China
Search for more papers by this authorJack G Zhou
Xi'an Advanced Medical Technology Co., Ltd, Xi'an, 710000 China
Search for more papers by this authorCorresponding Author
Tingzhang Hu
Key Laboratory for Biorheological Science and Technology of Ministry of Education, State and Local Joint Engineering Laboratory for Vascular Implants, Bioengineering College of Chongqing University, Chongqing, 400030 China
Correspondence to: G. Wang; e-mail: [email protected] or T. Hu; e-mail: [email protected]Search for more papers by this authorCorresponding Author
Guixue Wang
Key Laboratory for Biorheological Science and Technology of Ministry of Education, State and Local Joint Engineering Laboratory for Vascular Implants, Bioengineering College of Chongqing University, Chongqing, 400030 China
Correspondence to: G. Wang; e-mail: [email protected] or T. Hu; e-mail: [email protected]Search for more papers by this authorAbstract
Zinc (Zn) and its alloys have been proved to be promising candidate materials for biodegradable cardiovascular stents. In this study, a novel extruded Zn–0.02 Mg–0.02Cu alloy was prepared. Compared with pure Zn, the Zn-based alloy showed higher mechanical properties, and the Zn-based alloy could significantly accelerate Zn2+ release, reaching 0.61 ± 0.11 μg/mL at 15 days of immersion. In vitro biocompatibility studies demonstrated that the Zn-based alloy had excellent cytocompatibility and hemocompatibility, including low hemolysis rate (0.63 ± 0.12%) and strong inhibitory effect on platelet adhesion. Subsequently, the Zn-based alloy stent was implanted into the left carotid arteries of New Zealand white rabbits for 12 months. All the rabbits survived without any adverse clinical events, and all the stented arteries were patent during the study period. Rapid endothelialization at 1 week of implantation was observed, suggesting a low cytotoxicity and thrombosis risk. The stent corroded slowly and no obvious intimal hyperplasia was observed for 6 months, after which corrosion accelerated at 12 months. In addition, no obvious thrombosis and systemic toxicity during implantation period were observed, indicating its potential as the backbone of biodegradable cardiovascular stents. © 2018 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater 107B: 1814–1823, 2019.
CONFLICT OF INTEREST
The authors declare no conflict of interest.
Supporting Information
Filename | Description |
---|---|
JBMB34274-sup-0001-Supinfo.docxWord 2007 document , 3.4 MB | Appendix S1: Supplementary Material |
Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.
REFERENCES
- 1Yahagi K, Kolodgie FD, Otsuka F, Finn AV, Davis HR, Joner M, Virmani R. Pathophysiology of native coronary, vein graft, and in-stent atherosclerosis. Nat Rev Cardiol 2016; 13: 79–98.
- 2Hu T, Yang J, Cui K, Rao Q, Yin T, Tan L, Zhang Y, Li Z, Wang G. Controlled slow-release drug-eluting stents for the prevention of coronary restenosis: Recent progress and future prospects. ACS Appl Mater Interfaces 2015; 7: 11695–11712.
- 3Dangas GD, Claessen BE, Caixeta A, Sanidas EA, Mintz GS, Mehran R. In-stent restenosis in the drug-eluting stent era. J Am Coll Cardiol 2010; 56: 1897–1907.
- 4Hu T, Lin S, Du R, Fu M, Rao Q, Yin T, Huang Y, Wang G. Design, preparation and performance of a novel drug-eluting stent with multiple layer coatings. Biomater Sci 2017; 5: 1845–1857.
- 5Kereiakes DJ, Cox DA, Hermiller JB, Midei MG, Bachinsky WB, Nukta ED, Leon MB, Fink S, Marin L, Lansky AJ. Usefulness of a cobalt chromium coronary stent alloy. Am J Cardiol 2003; 92: 463–466.
- 6Barth KH, Virmani R, Froelich J, Takeda T, Lossef SV, Newsome J, Jones R, Lindisch D. Paired comparison of vascular wall reactions to Palmaz stents, Strecker tantalum stents, and Wallstents in canineiliac and femoral arteries. Circulation 1996; 93: 2161–2169.
- 7Cook S, Wenaweser P, Togni M, Billinger M, Morger C, Seiler C, Vogel R, Hess O, Meier B, Windecker S. Incomplete stent apposition and very late stent thrombosis after drug-eluting stent implantation. Circulation 2007; 115: 2426–2434.
- 8Finn AV, Virmani R. The clinical challenge of disappearing stents. Lancet 2016; 387: 510–512.
- 9Bowen PK, Drelich J, Goldman J. Zinc exhibits ideal physiological corrosion behavior for bioabsorbable stents. Adv Mater 2013; 25: 2577–2582.
- 10Wang YB, Zhang XD. Vascular restoration therapy and bioresorbable vascular scaffold. Regen Biomater 2014; 1: 49–55.
- 11Ormiston JA, Serruys PW. Bioabsorbable coronary stents. Circ Cardiovasc Interv 2009; 2: 255–260.
- 12Wykrzykowska JJ, Kraak RP, Hofma SH, van der Schaaf RJ, Arkenbout EK, IJsselmuiden AJ, Elias J, van Dongen IM, Tijssen RY, Koch KT, JJr B, Vis MM, de Winter RJ, Piek JJ, Tijssen JG, Henriques JP, Investigators AIDA. Bioresorbable scaffolds versus metallic stents in routine PCI. N Engl J Med 2017; 376: 2319–2328.
- 13Montone RA, Niccoli G, De Marco F, Minelli S, D'Ascenzo F, Testa L, Bedogni F, Crea F. Temporal trends in adverse events after everolimus-eluting bioresorbable vascular scaffold versus everolimus-eluting metallic stent implantation: A meta-analysis of randomized controlled trials. Circulation 2017; 135: 2145–2154.
- 14Bowen PK, Shearier ER, Zhao S, Guillory RJ, Zhao F, Goldman J, Drelich JW. Biodegradable metals for cardiovascular stents: From clinical concerns to recent Zn-alloys. Adv Healthc Mater 2016; 5: 1121–1140.
- 15Zheng YF, Gu XN, Witte F. Biodegradable metals. Mater Sci Eng R 2014; 77: 1–34.
- 16Waksman R, Erbel R, Di Mario C, Bartunek J, de Bruyne B, Eberli FR, Erne P, Haude M, Horrigan M, Ilsley C, Böse D, Bonnier H, Koolen J, Lüscher TF, Weissman NJ, PROGRESS-AMS Investigators. Early- and long-term intravascular ultrasound and angiographic findings after bioabsorbable magnesium stent implantation in human coronary arteries. JACC Cardiovasc Intev 2009; 2: 312–320.
- 17Schildwächter M, Biotronik Announces CE Mark for Magmaris, the First Clinically Proven Bioresorbable Magnesium Scaffold, 2016. Available from: https://www.biotronik.com/en-bg/newsroom/press-releases/press-release-magmaris-ce-mark-june15-en.
- 18Pierson D, Edick J, Tauscher A, Pokorney E, Bowen P, Gelbaugh J, Stinson J, Getty H, Lee CH, Drelich J, Goldman J. A simplified in vivo approach for evaluating the bioabsorbable behavior of candidate stent materials. J Biomed Mater Res B Appl Biomater 2012; 100: 58–67.
- 19Peuster M, Wohlsein P, Brügmann M, Ehlerding M, Seidler K, Fink C, Brauer H, Fischer A, Hausdorf G. A novel approach to temporary stenting: Degradable cardiovascular stents produced from corrodible metal-results 6–18 months after implantation into New Zealand white rabbits. Heart 2001; 86: 563–569.
- 20Lin W, Qin L, Qi H, Zhang D, Zhang G, Gao R, Qiu H, Xia Y, Cao P, Wang X. Long-term in vivo corrosion behavior, biocompatibility and bioresorption mechanism of a bioresorbable nitrided iron stent. Acta Biomater 2017; 54: 454–468.
- 21Dou KF, Shu C, Sievert H, Wu YJ. The first-in-man implantation of the IBS™ sirolimus-eluting iron absorbable coronary stent system, 2018. Available from: http://www.lifetechmed.com/en/news/n1/20180612/2070.aspx.
- 22Prasad AS. Zinc in human health: Effect of zinc on immune cells. Mol Med 2008; 14: 353–357.
- 23Prasad AS. Clinical, immunological, anti-inflammatory and antioxidant roles of zinc. Exp Geront 2008; 43: 370–377.
- 24Li HF, Xie XH, Zheng YF, Cong Y, Zhou FY, Qiu KJ, Wang X, Chen SH, Huang L, Tian L, Qin L. Development of biodegradable Zn-1X binary alloys with nutrient alloying elements Mg, Ca and Sr. Sci Rep 2015; 5: 10719.
- 25Hennig B, Toborek M, Mcclain CJ. Antiatherogenic properties of zinc: Implications in endothelial cell metabolism. Nutrition 1996; 12: 711–717.
- 26Bowen PK, Guillory RJ, Shearier ER, Seitz JM, Drelich J, Bocks M, Zhao F, Goldman J. Metallic zinc exhibits optimal biocompatibility for bioabsorbable endovascular stents. Korean J Couns Psychother 2015; 56: 467–472.
- 27Drelich AJ, Zhao S, Guillory RJ, Drelich JW, Goldman J. Long-term surveillance of zinc implant in murine artery: Surprisingly steady biocorrosion rate. Acta Biomater 2017; 58: 539–549.
- 28Zhao S, Seitz JM, Eifler R, Maier HJ, Guillory RJ, Earley EJ, Drelich A, Goldman J, Drelich JW. Zn-li alloy after extrusion and drawing: Structural, mechanical characterization, and biodegradation in abdominal aorta of rat. Korean J Couns Psychother 2017; 76: 301–312.
- 29Yang H, Wang C, Liu C, Chen H, Wu Y, Han J, Jia Z, Lin W, Zhang D, Li W, Yuan W, Guo H, Li H, Yang G, Kong D, Zhu D, Takashima K, Ruan L, Nie J, Li X, Zheng Y. Evolution of the degradation mechanism of pure zinc stent in the one-year study of rabbit abdominal aorta model. Biomaterials 2017; 145: 92–105.
- 30Vojtěch D, Kubásek J, Serák J, Novák P. Mechanical and corrosion properties of newly developed biodegradable Zn-based alloys for bone fixation. Acta Biomater 2011; 7: 3515–3522.
- 31Mostaed E, Sikora-Jasinska M, Drelich JW, Vedani M. Zinc-based alloys for degradable vascular stent applications. Acta Biomater 2018; 71: 1–23.
- 32 ASTM, ASTM-E8/E8m-11: Standard Test Methods for Tension Testing of Metallic Materials, Annual Book of ASTM Standards, 2011.
- 33 ASTM, ASTM-G31-72: Standard Practice for Laboratory Immersion Corrosion Testing of Metals, Annual Book of ASTM Standards, 2004.
- 34Bowen PK, Drelich A, Drelich J, Goldman J. Rates of in vivo (arterial) and in vitro biocorrosion for pure magnesium. J Biomed Mater Res A 2015; 103: 341–349.
- 35Tang ZB, Huang H, Niu JL, Zhang L, Zhang H, Pei J, Tan JY, Yuan GY. Design and characterizations of novel biodegradable Zn–Cu–Mg alloys for potential biodegradable implants. Mater Design 2017; 117: 84–94.
- 36 ASTM, ASTM-F756-08: Standard Practice for Assessment of Hemolytic Properties of Materials. Annual Book of ASTM Standards, 2008.
- 37Joner M, Nakazawa G, Finn AV, Quee SC, Coleman L, Acampado E, Wilson PS, Skorija K, Cheng Q, Xu X, Gold HK, Kolodgie FD, Virmani R. Endothelial cell recovery between comparator polymer-based drug-eluting stents. J Am Coll Cardiol 2008; 52: 333–342.
- 38O'Brien B, Carroll W. The evolution of cardiovascular stent materials and surfaces in response to clinical drivers: A review. Acta Biomater 2009; 5: 945–958.
- 39Ma J, Zhao N, Zhu D. Endothelial cellular responses to biodegradable metal zinc. ACS Biomater Sci Eng 2015; 1: 1174–1182.
- 40Shearier ER, Bowen PK, He W, Drelich A, Drelich J, Goldman J, Zhao F. In vitro cytotoxicity, adhesion, and proliferation of human vascular cells exposed to zinc. ACS Biomater Sci Eng 2016; 2: 634–642.
- 41Ma J, Zhao N, Zhu D. Bioabsorbable zinc ion induced biphasic cellular responses in vascular smooth muscle cells. Sci Rep 2016; 6: 26661.