Biodegradable and Bioabsorbable stents

Current Pharmaceutical Design

Volumn 16, Issue 36, 2010, Pages 4041-4051

  Waksman, Ron ^a   Pakala, Rajbabu ^a  

^a WASHINGTON HOSPITAL CENTER   (United States)

Author keywords

Bioabsorption; Biodegradation; Drug; Restenosis; Stent

Indexed keywords

POLYCARBONATE; POLYESTER; POLYLACTIC ACID; RAPAMYCIN; SALICYLIC ACID;

ARTICLE; BARE METAL STENT; BIOABSORBABLE STENT; BIODEGRADABLE IMPLANT; BIODEGRADABLE STENT; BLOOD VESSEL INJURY; CORONARY ARTERY; DRUG COATING; DRUG DELIVERY SYSTEM; DRUG ELUTING STENT; FEASIBILITY STUDY; FLUOROSCOPY; HUMAN; IN-STENT RESTENOSIS; INFLAMMATION; LIMB ISCHEMIA; NONHUMAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESTENOSIS; VASCULAR LESION;

BIOCOMPATIBLE MATERIALS; CHILD; CORONARY VESSELS; HUMANS; STENTS;

EID: 79952657434     PISSN: 13816128     EISSN: None     Source Type: Journal    
DOI: 10.2174/138161210794454905     Document Type: Article

References (81)

1. Dotter CT, Judkins MP. Transluminal treatment of arteriosclerotic obstruction. description of a new technic and a preliminary report of its application. Circulation 1964; 30: 654-70.
2. Gruentzig AR. Percutaneous transluminal coronary angioplasty. Semin Roentgenol 1981; 16: 152-3.
3. Mintz GS, Popma JJ, Pichard AD, et al. Arterial remodeling after coronary angioplasty: A serial intravascular ultrasound study. Circulation 1996; 94: 35-43.
4. Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L. Intravascular stents to prevent occlusion and restenosis after translu-minal angioplasty. N Engl J Med 1987; 316: 701-6.
5. Palmaz JC, Richter GM, Noldge G, Kauffmann GW, Wenz W. Intraluminal Palmaz stent implantation. The first clinical case report on a balloon- expanded vascular prosthesis. Radiologe 1987; 27: 560-3.
6. Condado JA, Waksman R, Gurdiel O, et al. Long-term angi-ographic and clinical outcome after percutaneous transluminal coronary angioplasty and intracoronary radiation therapy in humans. Circulation 1997; 96: 727-32.
7. Teirstein PS, Massullo V, Jani S, et al. Catheter-based radiotherapy to inhibit restenosis after coronary stenting. N Engl J Med 1997; 336: 1697-703.
8. Costa MA, Sabaté M, van der Giessen WJ, et al. Late coronary occlusion after intracoronary brachytherapy. Circulation 1999; 100: 789-92.
9. Doriot PA, Dorsaz PA, Verin V. A morphological-mechanical explanation of edge restenosis in lesions treated with vascular brachytherapy. Cardiovasc Radiat Med 2003; 4: 108-15.
10. Indolfi C, Mongiardo A, Curcio A, Torella D. Molecular mechanisms of in-stent restenosis and approach to therapy with eluting stents. Trends Cardiovasc Med 2003; 13: 142-8.
11. Lowe HC, Oesterle SN, Khachigian LM Coronary in-stent resteno-sis: Current status and future strategies. J Am Coll Cardiol 2002; 39: 183-93.
12. Beyar R Novel approaches to reduce restenosis. Ann N Y Acad Sci 2004; 1015: 367-78.
13. Ong AT, Aoki J, McFadden EP, Serruys PW. Classification and current treatment options of in-stent restenosis. Present status and future perspectives. Herz 2004; 29: 187-94.
14. Kim BK, Oh S, Jeon DW, et al. For The Korean Multicenter Angioplasty Team (Komate) Investigatorslong-term clinical outcomes and stent thrombosis of sirolimus-eluting versus bare metal stents in patients with end-stage renal disease: results of korean multicenter angioplasty team (komate) registry. J Interv Cardiol 2009: 22: 411-9.
15. Kawaguchi R, Angiolillo DJ, Futamatsu H, Suzuki N, Bass TA, Costa MA. Stent thrombosis in the era of drug eluting stents. Minerva Cardioangiol 2007; 55: 199-211.
16. Center for Devices and Radiological Health. Circulatory system devices panel: CDRH Advisory Committee, Food and Drug Administration; December 7-8, 2006; Gaithersburg, MD.
17. Erne P, Schier M, Resink TJ. The road to bioabsorbable stents: reaching clinical reality? Cardiovasc Intervent Radiol 2006; 29: 11-6.
18. Ramcharitar S, Vaina S, Serruys PW. The next generation of drug-eluting stents: what's on the horizon? Am J Cardiovasc Drugs 2007; 7: 81-93.
19. Aoki J, Ong AT, Rodriguez Granillo GA, et al. "Full metal jacket" (stented length > or = 64 mm) using drug-eluting stents for de novo coronary artery lesions. Am Heart J 2005; 150: 994-9.
20. Hoffmann R, Mintz GS, Popma JJ, et al. Chronic arterial responses to stent implantation: a serial intravascular ultrasound analysis of Palmaz-Schatz stents in native coronary arteries. J Am Coll Cardiol 1996; 28: 1134-9.
21. Spuentrup E, Ruebben A, Mahnken A, et al. Artifact-free coronary magnetic resonance angiography and coronary vessel wall imaging in the presence of a new, metallic, coronary magnetic resonance imaging stent. Circulation 2005; 111: 1019-26.
22. Pinto Slottow TL, Waksman R. Overview of the 2006 food and drug administration circulatory system devices panel meeting on drug-eluting stent thrombosis. Catheter Cardiovasc Interv 2007; 69: 1064-74.
23. Stack RE, Califf RM, Phillips HR, et al. Interventional cardiac catheterization at Duke Medical Center. Am J Cardiol 1988; 62(suppl F): 3F-24.
24. van der Giessen WJ, Lincoff AM, Schwartz RS, et al. Marked inflammatory sequelae to implantation of biodegradable and non-biodegradable polymers in porcine coronary arteries. Circulation 1996; 94: 1690-7.
25. Venkatraman S, Poh TL, Vinalia T, Mak KH, Boey F. Collapse pressures of biodegradable stents. Biomaterials 2003; 24: 2105-11.
26. Uurto I, Juuti H, Parkkinen J, et al. Biodegradable self-expanding poly-L/D-lactic acid vascular stent: a pilot study in canine and porcine iliac arteries. J Endovasc Ther 2004; 11: 712-8.
27. Vogt F, Stein A, Rettemeier G, et al. Long-term assessment of a novel biodegradable paclitaxel-eluting coronary polylactide stent. Eur Heart J 2004; 25: 1330-40.
28. Asplund B, Sperens J, Mathisen T, Hilborn J. Effects of hydrolysis on a new biodegradable co-polymer. J Biomater Sci Polym Ed 2006; 17: 615-30.
29. Hastings G.W. Ed. Cardiovascular Biomaterials. London: Springer-Verlag 1992.
30. Murphy JG, Schwartz RS, Huber KC, Holmes DR Jr. Polymeric stents: modern alchemy or the future?. J Invasive Cardiol 1991; 3: 144-8.
31. Tsuji T, Tamai H, Kyo E. The effect of PLLA stent design on neointimal hyperplasia. J Cardiol 1998; 32: 235A.
32. Eury KR. Multi-layered biodegradable stent and method for its manufacture. European Patent 604022 A1.
33. Lincoff AM, Furst JG, Ellis SG, Tuch RJ, Topol EJ. Sustained local delivery of dexamethasone by a novel intravascular eluting stent to prevent restenosis in the porcine coronary injury model. J Am Coll Cardiol 1997; 29: 808-16.
34. Tamai H, Igaki K, Tsuji T, et al. A biodegradable poly-l-lactic acid coronary stent in porcine coronary artery. J Interv Cardiol 1999; 12: 443-50.
35. Hietala EM, Salminen US, Stahls A, et al. Biodegradation of the copolymeric polylactide stent: Long-term follow-up in a rabbit aorta model. J Vasc Res 2001; 38: 361-9.
36. Yamawaki T, Shimokawa H, Kozai T, et al. Intramural delivery of a specific tyrosine kinase inhibitor with biodegradable stent suppresses the restenotic changes of the coronary artery in pigs in vivo. J Am Coll Cardiol 1998; 32: 780-6.
37. Ye YW, Landau C, Willard JE, et al. Bioresorbable microporous stents deliver recombinant adenovirus gene transfer vectors to the arterial wall. Ann Biomed Eng 1998; 26: 398-408.
38. Ye YW, Landau C, Meidell RS, et al. Improved bioresorbable microporous intravascular stents for gene therapy. ASAIO J 1996; 42: M823-7.
39. Tamai H, Igaki K, Kyo E, et al. Initial and 6-month results of biodegradable poly-l-lactic acid coronary stents in humans. Circulation 2000; 102: 399-404.
40. Tsuji T, Tamai H, Igaki K, et al. Biodegradable polymeric stents. Curr Interv Cardiol Rep 2001; 3: 10-7.
41. Tamai H. Biodegradable stents four-year follow-up [presentation]. Complex Coronary Therapeutics; 2004 Oct 21-24; Kobe.
42. Ormiston JA, Serruys PW, Regar E, et al. A bioabsorbable ever-olimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet 2008; 371: 899-907.
43. Serruys PW, Ormiston JA, Onuma Y, et al. A bioabsorbable ever-olimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet 2009; 373: 897-910.
44. Schultz R. REVA Medical, Inc., Bioabsorbable Technology. Presented at the Cardiovascular Research Technologies. Annual Meeting, March 4-6, 2006; Washington, DC.
45. Grube E. Bioabsorbable stent. The Boston Scientific and REVA technology. Presented at EuroPCR May 19-22, 2009: Barcelona, Spain.
46. Garg S, Serruys PW. Biodegradable stents and non-biodegradable stents. Minerva Cardioangiol 2009; 57: 537-65.
47. Jabara R, Chronos N, Robinson K. Novel bioabsorbable salicylate-based polymer as a drug-eluting stent coating. Catheter Cardiovasc Interv 2008; 72: 186-94.
48. Jabara R, Pendyala L, Geva S, Chen J, Chronos N, Robinson K. Novel fully bioabsorbable salicylate-based sirolimuseluting stent EuroIntervention F 2009; Suppl F; 58-F64.
49. Jabara R. Poly-anhydride based on salicylic acid and adipic acid anhydride. Presented at EuroPCR May 19-22, 2009: Barcelona, Spain.
50. Heublein B, Rohde R, Kaese V, Niemeyer M, Hartung W, Haverich A. Biocorrosion of magnesium alloys: a new principle in cardiovascular implant technology? Heart 2003; 89: 651-6.
51. Peeters P, Bosiers M, Verbist J, Deloose K, Heublein B. Preliminary results after application of absorbable metal stents in patients with critical limb ischemia. J Endovasc Ther 2005; 12: 1-5.
52. Waksman R, Pakala R, Kuchulakanti PK, et al. Safety and efficacy of bioabsorbable magnesium alloy stents in porcine coronary arteries. Catheter Cardiovasc Interv 2006; 68: 606-17.
53. Peuster M, Wohlsein P, Brugmann M, et al. 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: 563-9.
54. Waksman R, Pakala R, Baffour R, Seabron R, Hellinga D, Tio FO. Short-term effects of biocorrodible iron stents in porcine coronary arteries. J Interv Cardiol 2008; 21: 15-20.
55. Hermawan H, Alamdari H, Mantovani D, Dubé D. Iron- manganese: new class of degradable metallic biomaterials prepared by powder metallurgy. Powder Metall 2008; 51: 38-45.
56. Peuster M, Hesse C, Schloo T, Fink C, Beerbaum P, von Schnak-enburg C. Longterm biocompatibility of a corrodible peripheral iron stent in the porcine descending aorta. Biomaterials 2006; 27: 4955-62.
57. Balcon R, Beyar R, Chierchia S, et al. Recommendations on stent manufacture, implantation and utilization. Eur Heart J 1997; 18: 1536-47.
58. Heublein B, Hausdorf G. Metallic stent which is degradable in vivo. EPO 2002: EP1270023.
59. Levesque J, Dube D, Fiset M, Mantovani D. Investigation of corrosion behaviour of magnesium alloy AM60B-F under pseudo-physiological conditions. Mater Sci Forum 2003; 521-6.
60. Klocke B, Diener T, Fringes M, Harder C. Degradable metal stent having agent-containing coating. USPTO 2009: US20090030507.
61. Bolz A, Popp T. Implantable, bioresorbable vessel wall support, in particular coronary stent. USPTO 2001: US20016287332.
62. Mueller H. Stent having a base body of a biocorrodable alloy. USPTO 2009: US20090069884.
63. Andrews NC. Disorders of iron metabolism. N Engl J Med 1999; 341: 1986-95.
64. Emsley J. The elements. Oxford: Clarendon Press 1998.
65. Mueller PP, May T, Perz A, Hauser H, Peuster M. Control of smooth muscle cell proliferation by ferrous iron. Biomaterials 2006; 27: 2193-200.
66. Saris NE, Mervaala E, Karppanen H, Khawaja JA, Lewenstam A. Magnesium. An update on physiological, clinical and analytical aspects. Clin Chim Acta 2000; 294: 1-26.
67. Vormann J. Magnesium: nutrition and metabolism. Mol Aspects Med 2003; 24: 27-37.
68. Song G. Control of biodegradation of biocompatible magnesium alloys. Corros Sci 2007; 49: 1696-701.
69. Li Z, Gu X, Lou S, Zheng Y. The development of binary Mg-Ca alloys for use as biodegradable materials within bone. Biomaterials 2008; 29: 1329-44.
70. Currey J. Cortical bone. In: Black J, Hastings G, Eds. Handbook of biomaterial properties. London: Chapman & Hall 1998; pp. 3-14.
71. Staiger MP, Pietak AM, Huadmai J, Dias G. Magnesium and its alloys as orthopedic biomaterials: a review. Biomaterials 2006; 27: 1728-34.
72. Waksman R, Pakala R, Okabe T, et al. Efficacy and safety of ab-sorbable metallic stents with adjunct intracoronary beta radiation in porcine coronary arteries. J Interv Cardiol 2007; 20: 367-72.
73. Zartner P, Cesnjevar R, Singer H, Weyand M. First successful implantation of a biodegradable metal stent into the left pulmonary artery of a preterm baby. Catheter Cardiovasc Interv 2005; 66: 590-4.
74. Schranz D, Zartner P, Michel-Behnke I, Akinturk H. Bioabsorbable metal stents for percutaneous treatment of critical recoarctation of the aorta in a newborn. Catheter Cardiovasc Interv 2006; 67: 671-3.
75. Zartner P, Buettner M, Singer H, Sigler M. First biodegradable metal stent in a child with congenital heart disease: evaluation of macro and histopathology. Catheter Cardiovasc Interv 2007; 69: 443-6.
76. McMahon CJ, Oslizlok P, Walsh KP. Early restenosis following biodegradable stent implantation in an aortopulmonary collateral of a patient with pulmonary atresia and hypoplastic pulmonary arteries. Catheter Cardiovasc Interv 2007; 69: 735-8.
77. Bosiers M, Deloose K, Verbist J, Peeters P. Percutaneous translu-minal angioplasty for treatment of below-the-knee critical limb ischemia: Early outcomes following the use of sirolimus-eluting stents. J Cardiovasc Surg (Torino) 2006; 47: 171-6.
78. Bosiers M, Peeters P, D'Archambeau O, et al. AMSINSIGHT- absorbable metal stent implantation for treatment of below-theknee critical limb ischemia: 6-month analysis. Cardiovasc Intervent Radiol 2009: 32: 424-35.
79. Erbel R, Di Mario C, Bartunek J, et al. PROGRESS-AMS (Clinical Performance and Angiographic Results of Coronary Stenting with Absorbable Metal Stents) Investigators. Temporary scaffolding of coronary arteries with bioabsorbable magnesium stents: a prospective, non-randomised multicentre trial. Lancet 2007; 369: 1869-75.
80. Waksman R, Erbel R, Di Mario C, et al. PROGRESS-AMS (Clinical Performance Angiographic Results of Coronary Stenting with Absorbable Metal Stents) Investigators. Early- and long-term in-travascular ultrasound and angiographic findings after bioabsorb-able magnesium stent implantation in human coronary arteries. JACC Cardiavasc Interv 2009; 2: 312-20.
81. Ghimire G, Spiro J, Kharbanda R, et al. Initial evidence for the return of coronary vaso reactivity following the absorption of bio-absorbable magnesium alloy coronary stents. EuroIntervention 2009; 4: 481-4.