Biodegradable metal stents: A focused review on materials and clinical studies

Journal of Biomaterials and Tissue Engineering

Volumn 4, Issue 11, 2014, Pages 868-874

  Purnama, Agung ^a   Hermawan, Hendra ^a   Mantovani, Diego ^a  

^a University Laval   (Canada)

Author keywords

Biodegradable Metals; Biodegradable Stent; Coronary Artery Disease; Iron; Magnesium; Zinc

Indexed keywords

ALLOY; IRON; MAGNESIUM; NITINOL; STAINLESS STEEL; ZINC;

ARTERIAL WALL THICKNESS; ARTERY BLOOD FLOW; ARTERY CATHETERIZATION; ARTICLE; BIOCOMPATIBILITY; BIODEGRADABLE IMPLANT; BIODEGRADABLE METAL STENT; CARDIOVASCULAR INFLAMMATION; CORONARY ARTERY DISEASE; DEGRADATION; DRUG ELUTING CORONARY STENT; HUMAN; METAL STENT; METALLIC IMPLANT CORROSION; NONHUMAN; OUTCOME ASSESSMENT; STENT THROMBOSIS; TOXICITY; TRANSLUMINAL CORONARY ANGIOPLASTY;

ANIMALIA;

EID: 84921324952     PISSN: 21579083     EISSN: 21579091     Source Type: Journal    
DOI: 10.1166/jbt.2014.1263     Document Type: Article

References (41)

1. A. S. Go, D. Mozaffarian, V. L. Roger, E. J. Benjamin, J. D. Berry, M. J. Blaha, S. Dai, E. S. Ford, C. S. Fox, S. Franco, H. J. Fullerton, C. Gillespie, S. M. Hailpern, J. A. Heit, V. J. Howard, M. D. Huffman, S. E. Judd, B. M. Kissela, S. J. Kittner, D. T. Lackland, J. H. Lichtman, L. D. Lisabeth, R. H. Mackey, D. J. Magid, G. M. Marcus, A. Marelli, D. B. Matchar, D. K. McGuire, E. R. Mohler 3rd, C. S. Moy, M. E. Mussolino, R. W. Neumar, G. Nichol, D. K. Pandey, N. P. Paynter, M. J. Reeves, P. D. Sorlie, J. Stein, A. Towfighi, T. N. Turan, S. S. Virani, N. D. Wong, D. Woo, and M. B. Turner, American heart association statistics committee and stroke statistics subcommittee, heart disease and stroke statistics-2014 update: A report from the american heart association. Circulation 129, e28 (2014).
2. S. Allender, P. Scarborough, V. Peto, M. Rayner, J. Leal, R. Luengo-Fernandez, and A. Gray, European cardiovascular disease statistics, European Heart Network, Brussels, England (2008).
3. P. W. Serruys, P. de Jaegere, F. Kiemeneij, C. Macaya, W. Rutsch, G. Heyndrickx, H. Emanuelsson, J. Marco, V. Legrand, P. Materne, J. Belardi, U. Sigwart, A. Colombo, J. J. Goy, P. van den Heuvel, and J. Delcan, Marie-Angele Morel for the Benestent Study Group, A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. New England Journal of Medicine 331, 489 (1994).
4. P. P. Mueller, T. May, A. Perz, H. Hauser, and M. Peuster, Control of smooth muscle cell proliferation by ferrous iron. Biomaterials 27, 2193 (2006).
5. P. W. Serruys, M. J. Kutryk, and A. T. Ong, Coronary-artery stents. New England Journal of Medicine 354, 483 (2006).
6. D. J. Molitermo, Healing achilles–serolimus versus paclitaxel. New England Journal of Medicine 353, 724 (2005).
7. J. Daemen, P. Wenaweser, and K. Tsuchida, Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: Data from a large two-institutional cohort study. Lancet 369, 667 (2007).
8. M. Joner, A. V. Finn, and A. Farb, Pathology of drug-eluting stents in human: Delayed healing and late thrombosis risk. Journal of Amer-ical College of Cardiology 48, 193 (2006).
9. R. Virmani, F. Liistro, and G. Stankovic, Mechanism of late in-stent restenosis after implantation of a paclitaxel derivate-eluting polymer stent system in humans. Circulation 106, 2649 (2002).
10. T. F. Lüscher, J. Steffel, F. R. Eberli, M. Joner, G. Nakazawa, F. C. Tanner, and R. Virmani, Drug-eluting stent and coronary thrombosis: Biological mechanisms and clinical implications. Circulation 115, 1051 (2007).
11. A. K. Hassan, S. C. Bergheanu, T. Stijnen, B. L. van der Hoeven, J. D. Snoep, J. W. Plevier, M. J. Schalij, and J. W. Jukema, Late stent malapposition risk is higher after drug-eluting stent compared with bare-metal stent implantation and associates with late stent thrombosis. European Heart Journal 31, 1172 (2010).
12. H. Hermawan and D. Mantovani, Degradable metallic biomaterials: The concept, current developments and future directions. Minerva Biotecnol. 21, 207 (2009).
13. J. A. Ormiston and P. W. S. Serruys, Bioabsorbable coronary stents. Circulation: Cardiovascular Interventions 2, 255 (2009).
14. Y. F. Zheng, X. N. Gu, and F. Witte, Biodegradable metals. Materials Science and Engineering: R: Reports 77, 1 (2014).
15. J. Vormann, Magnesium: Nutrition and metabolism. Molecular Aspects of Medicine 24, 27 (2003).
16. B. Heublein, B. Rohde, V. Kaese, M. Niemeyer, W. Hartung, and A. Haverich, Biocorrosion of magnesium alloys: A new principle in cadiovascular implant technology. Heart 89, 651 (2003).
17. Y. Chen, J. Yan, C. Zhao, S. Zhang, S. Yu, Z. Wang, X. Wang, X. Zhang, and Q. Zheng, In vitro and in vivo assessment of the bio-compatibility of an Mg-6Z(n) alloy in the bile. Journal of Materials Science: Materials in Medicine 25, 471 (2014).
18. M. Bosiers, P. Peeters, O. D’Archambeau, J. Hendriks, E. Pilger, C. Duber, T. Zeller, A. Gussmann, P. N. M. Lohle, E. Minar, D. Scheinert, K. Hausegger, K.-L. Schulte, J. Verbist, K. Deloose, and J. Lammer, AMS INSIGHT-Absorbable metal stent implanta tion for treatment of below-the-knee critical limb ischemia: 6-month analysis. Cardiovascular Interventional Radiology 32, 424 (2009).
19. R. Erbel, C. Di Mario, J. Bartunek, J. Bonnier, B. de Bruyne, F. R. Eberli, et al., Temporary scaffolding of coronary arteries with bioab-sorbable magnesium stents: A prospective, non-randomised multi-centre trial. Lancet 369, 1869 (2007).
20. R. Waksman, R. Pakala, R. Baffour, R. Seabron, D. Hellinga, and F. O. Tio, Short-term effects of biocorrodible iron stents in porcine coronary arteries. Journal of Interventional Cardiology 21, 15 (2008).
21. M. Peuster, C. Hesse, T. Schloo, C. Fink, P. Beerbaum, and C. V. Schnakenburg, Long term biocompatibility of a corrodible peripheral iron stent in the porcine descending aorta. Biomaterials 27, 4955 (2006).
22. A. Drynda, T. Hassel, F. W. Bach, and M. Peuster, In vitro and in vivo corrosion properties of new iron-manganese alloys designed for cardiovascular applications. Journal of Biomedical Materials Research B 00B, 000 (2014), DOI:10.1002/jbm.b.33234.
23. H. Hermawan, D. Dube, and D. Mantovani, Developments in metallic biodegradable stents. Acta Biomaterialia 6, 1693 (2010).
24. T. Kraus, F. Moszner, S. Fischerauer, M. Fiedler, E. Martinelli, J. Eichler, F. Witte, E. Willbold, M. Schinhammer, M. Meischel, P. J. Uggowitzer, J. F. Loffler, and A. Weinberg, Biodegradable Fe-based alloys for use in osteosynthesis: Outcome of an in vivo study after 52 weeks. Acta Biomaterialia 10, 3346 (2014).
25. P. K. Bowen, J. Drelich, and J. Goldman, Zinc exhibits ideal physiological corrosion behavior for bioabsorbable stents. Advanced Materials 25, 2577 (2013).
26. D. Vojtech, J. Kubasek, J. Serak, and P. Novak, Mechanical and corrosion properties of newly developed biodegradable Zn-based alloys for bone fixation. Acta Biomaterialia 7, 3515 (2011).
27. D. Pierson, J. Edick, A. Tauscher, E. Pokorney, P. Bowen, J. Gelbaugh, J. Stinson, H. Getty, C. H. Lee, J. Drelich, and J. Goldman, A simplified in vivo approach for evaluating the bioab-sorbable behavior of candidate stent materials. Journal of Biomedical Materials Research B 100, 58 (2012).
28. Q. Feng, D. Zhang, C. Xin, X. Liu, W. Lin, W. Zhang, S. Chen, and K. Sun, Characterization and in vivo evaluation of a bio-corrodible nitrided iron stent. Journal of Materials Science: Materials in Medicine 24, 713 (2013).
29. M. Peuster, P. Wohlsein, M. Brugmann, M. Ehlerding, K. Seidler, C. Fink, H. Brauer, A. Fischer, and G. Hausdorf, A novel approach to temporary stenting: Degradable cardiovascular stents produced from corodble metal-results 6-18 months after implantation into New Zealand white rabbits. Heart 86, 563 (2001).
30. C. Di Mario, H. Griffiths, O. Goktekin, N. Peeters, J. Verbist, M. Bosiers, K. Deloose, B. Heublein, R. Rohde, V. Kasese, C. Ilsley, and R. Erbel, Drug-eluting bioabsorbable magnesium stent. Journal of Interventional Cardiology 17, 391 (2004).
31. P. Peeters, M. Bosiers, J. Verbist, K. Deloose, and B. Heublein, Preliminary results after application of absorable metal stents in patients with critical limb ischemia. Journal of Endovascular Therapy 12, 1 (2005).
32. R. Waksman, R. Pakala, R. Baffour, R. Seabron, D. Hellingga, and F. O. Tio, Short term effects of biocorrodible iron stents in porcine coronary arteries. Journal of Interventional Cardiology 21, 15 (2008).
33. P. Zartner, R. Cesnjevar, H. Singer, and M. Weyand, Firt successful implantation of a biodegradable metal stent into the left pulmonary artery of a preterm baby. Catheterization and Cardiovascular Interventions 66, 590 (2005).
34. D. Schranz, P. Zartner, I. Michel-Behnke, and H. Akinturk, Bioab-sorbable metal stents for percutaneous treatment of critical recoarc-tation of the aorta in a newborn. Catheterization and Cardiovascular Interventions 67, 671 (2006).
35. A. Loos, R. Rohde, A. Haverich, and S. Barlach, In vitro and in vivo biocompatibility testing of absorbable metal stents. Macromolecular Symposia 253, 103 (2007).
36. R. Erbel, C. Di Mario, J. Bartunek, J. Bonnier, B. Bruyne, F. R. Eberli, P. Erne, M. Haude, B. Heublein, M. Horrigan, C. Ilsley, D. Bose, J. Koolen, T. F. Luscher, N. Weissman, and R. Waksman, Temporary scaffolding of coronary arteries with bioabsorbable magnesium stents: A prospective, non-randomised multicenter trial. Lancet 369, 1869 (2007).
37. M. Maeng, L. O. Jensen, E. Falk, H. R. Andersen, and L. Thuesen, Negative vascular reodelling after implantation of bioabsorbable magnesium alloy stents in porcine coronary arteries: A randomised comparison with bare-metal and sirolimus-eluting stents. Heart 95, 241 (2009).
38. M. Peuster, C. Fink, P. Wohlsein, M. Bruegmann, A. Gunther, V. Kaese, M. Niemeyer, H. Haferkamp, and C. van Schnakenburg, Degradation of tungsten coils implanted into the subclavian artery of New Zealand white rabbits is not associated with local or systemic toxicity. Biomaterials 24, 393 (2003).
39. S. W. Shalaby and K. J. L. Burg, Absorbable and biodegradable polymers, Advances in Polymeric Biomaterials Series, CRC Press, New York (2004).
40. Y. Knobel, M. Glei, K. Osswald, and B. L. Pool-Zobel, Ferric iron increases ROS formation, modulates cell growth and enhances geno-toxic damage by 4-hydroxynonenal in human colon tumor cells. To x -icology in Vitro: An International Journal Published in Association with BIBRA 20, 793 (2006).
41. A. Purnama, H. Hermawan, J. Couet, and D. Mantovani, Assessing the biocompatibility of degradable metallic materials: State-of-the-art and focus on the potential of genetic regulation. Acta Biomateri-alia 6, 1800 (2010).