Progressive stent technologies: New approaches for the treatment of cardiovascular diseases

Expert Opinion on Drug Delivery

Volumn 3, Issue 6, 2006, Pages 783-797

  Vaina, Sophia ^a   Serruys, Patrick W ^a  

^a ERASMUS MEDICAL CENTER   (Netherlands)

Author keywords

Bioabsorbable stent; Drug eluting stent; Polymer coating; Stent design

Indexed keywords

ALUMINUM OXIDE; ANTIMITOTIC AGENT; BIOLIMUS A9; COBALT; DEXAMETHASONE; EVEROLIMUS; GLUCOCORTICOID; HEPARIN; HYDROXYAPATITE; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; MAGNESIUM; NITRIC OXIDE; PACLITAXEL; PHOSPHORYLCHOLINE; PIMECROLIMUS; POLYCAPROLACTONE; POLYGLACTIN; POLYLACTIC ACID; POLYLACTIDE; POLYMER; RAPAMYCIN; RAPAMYCIN DERIVATIVE; SIMVASTATIN; TITANIUM; TSUKUBAENOLIDE; UNCLASSIFIED DRUG; ZOTAROLIMUS;

ARTERY INTIMA PROLIFERATION; ATOPIC DERMATITIS; BIOCOMPATIBILITY; BIODEGRADABLE IMPLANT; BIOMEDICAL TECHNOLOGY ASSESSMENT; CARDIOVASCULAR DISEASE; CLINICAL TRIAL; CORONARY ARTERY DISEASE; CORONARY STENT; DRUG ACTIVATION; DRUG ELUTING STENT; DRUG MECHANISM; DRUG MEGADOSE; DRUG RELEASE; DRUG SAFETY; GRAFT REJECTION; HEART INFARCTION; HEART MUSCLE REVASCULARIZATION; HUMAN; IN-STENT RESTENOSIS; INTRAVASCULAR ULTRASOUND; LIMB ISCHEMIA; LOW DRUG DOSE; MATERIAL COATING; NONHUMAN; OUTCOME ASSESSMENT; PATIENT SAFETY; PERCUTANEOUS CORONARY INTERVENTION; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY; POROSITY; REVIEW; THROMBOSIS;

ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY; ANIMALS; CARDIOVASCULAR DISEASES; COATED MATERIALS, BIOCOMPATIBLE; CORONARY RESTENOSIS; EQUIPMENT DESIGN; HUMANS; PACLITAXEL; SIROLIMUS; STENTS;

EID: 33751209174     PISSN: 17425247     EISSN: None     Source Type: Journal    
DOI: 10.1517/17425247.3.6.783     Document Type: Review

References (78)

1. STONE GW, ELLIS SG, COX DA et al.: One-year clinical results with the slow-release, polymer-based, paclitaxel-eluting TAXUS stent: the TAXUS-IV trial. Circulation (2004) 109(16):1942-1947.
2. MORICE MC, SERRUYS PW, SOUSA JE et al.: A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N. Engl. J. Med. (2002) 346(23):1773-1780.
3. KUCHULAKANTI PK, CHU WW, TORGUSON R et al.: Correlates and long-term outcomes of angiographically proven stent thrombosis with sirolimus- and paclitaxel-eluting stents. Circulation (2006) 113(8):1108-1113.
4. LAKOVOU I, SCHMIDT T, BONIZZONI E et al.: Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA (2005) 293(17):2126-2130.
5. ONG AT, HOYE A, AOKI J et al.: Thirty-day incidence and six-month clinical outcome of thrombotic stent occlusion after bare-metal, sirolimus, or paclitaxel stent implantation. J. Am. Coll. Cardiol. (2005) 45(6):947-953.
6. ONG AT, MCFADDEN EP, REGAR E et al.: Late angiographic stent thrombosis (LAST) events with drug-eluting stents. J. Am. Coll. Cardiol. (2005) 45(12):2088-2092.
7. HOYE A, IAKOVOU I, GE L et al.: Long-term outcomes after stenting of bifurcation lesions with the 'crush' technique: predictors of an adverse outcome. J. Am. Coll. Cardiol. (2006) 47(10):1949-1958.
8. SMITH SC Jr, FELDMAN TE, HIRSHFELD JW Jr et al.: ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update 2001 Guidelines for Percutaneous Coronary Intervention). Circulation (2006) 113(7):el66-e286.
9. KASTRATI A, DIBRA A, MEHILLI J et al.: Predictive factors of restenosis after coronary implantation of sirolimus- or paclitaxel-eluting stents. Circulation (2006) 113(19):2293-2300.
10. KIM YH, PARK SW, HONG MK et al.: Comparison of simple and complex stenting techniques in the treatment of unprotected left main coronary artery bifurcation stenosis. Am. J. Cardiol. (2006) 97(11):1597-1601.
11. MEHILLI J, DIBRA A, KASTRATI A et al.: Randomized trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels. Eur. Heart J. (2006) 27(3):260-266.
12. HOYE A, TANABE K, LEMOS PA et al.: Significant reduction in restenosis after the use of sirolimus-eluting stents in the treatment of chronic total occlusions. J. Am. Coll. Cardiol. (2004) 43(11):1954-1958.
13. GE L, IAKOVOU I, COSGRAVE J et al.: Immediate and mid-term outcomes of sirolimus-eluting stent implantation for chronic total occlusions. Eur. Heart J. 2005) 26(11):1056-1062.
14. MEREDITH I, ORMISTON J, WHITBOURN R et al.: First-in-human study of the Endeavor ABT-578-eluting phosphorylcholine-encapsulated stent system in de nova native coronary artery lesions: Endeavor I Trial. EuroIntervention (2005) 1:157-164.
15. MEREDITH I, WIJNS W: ENDEAVOR I and II clinical program. Long term follow-up. European Society of Cardiology Congress. Stockholm, Sweden (4 September 2005).
16. KANDZARI DE: Overview of ABT-578/PC/Cobalt technology and clinical trial program. 55th Annual Scientific Session of the American College of Cardiology. Atlanta, GA, USA (11 - 16 March 2006).
17. KANDZARI DE, LEON MB: ENDEAVOR III. A randomized trial to confirm the safety and efficacy of the medtronic zotarolimus eluting stent in de novo native coronary artery lesions. 17th Transcatheter Cardiovascular Therapeutics Scientific Symposium. Washington, DC, USA (16 - 21 October 2005).
18. ABIZAID A, LANSKY A, FITZGERALD P et al.: Percutaneous coronary revascularization using a trilayer phosphorylocholine-coated zotarolimus-eluting stent: the ZoMaxx IVUS trial. 55th Annual Scientific Session of the American College of Cardiology. Atlanta, GA, USA (11 - 16 March 2006).
19. HONG MK, MINTZ GS, LEE CW et al.: Late stent malapposition after drug-eluting stent implantation: an intravascular ultrasound analysis with long-term follow-up. Circulation (2006) 113(3):414-419.
20. YEUNG AC: The Zomaxx Trials. 55th Annual Scientific Session of the American College of Cardiology. Atlanta, GA, USA (11 - 16 March 2006).
21. SERRUYS PW, ONG ATL, PIEK JJ et al.: A randomized comparison of a durable polymer Everolimus-eluting stent with a bare metal coronary stent: the SPIRIT first trial. EuroIntervention (2005) 1(1):58-69.
22. TSUCHIDA I,, PIEK JJ, NEUMANN FJ et al.: One-year results of a durable polymer everolimus-eluting stent in de novo coronary narrowings (The SPIRIT FIRST Trial). EuroIntervention (2005) 1:266-272.
23. STEPKOWSKI SM: Molecular targets for existing and novel immunosuppressive drugs. Expert Rev. Mol. Med. (2000) 2000:1-23.
24. KIPSHIDZE N, DANGAS G, TSAPENKO M et al.: Role of the endothelium in modulating neointimal formation: vasculoprotective approaches to attenuate restenosis after percutaneous coronary interventions. J. Am. Coll. Cardiol. (2004) 44(4):733-739.
25. WERNER N, JUNK S, LAUFS U et al.: Intravenous transfusion of endothelial progenitor cells reduces neointima formation after vascular injury. Circ. Res. (2003) 93(2):e17-e24.
26. AOKI J, SERRUYS PW, VAN BEUSEKOM H et al.: Endothelial progenitor cell capture by stents coated with antibody against CD34: the HEALING-FIM (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth-First In Man) registry. J. Am. Coll. Cardiol. (2005) 45(10):1574-1579.
27. SKETCH MH Jr, BALL M, RUTHERFORD B et al.: Evaluation of the Medtronic (Driver) cobalt-chromium alloy coronary stent system. Am. J. Cardiol. (2005) 95(1):8-12.
28. DUCKERS E: Endothelial progenitor cell capture (EPC): update and perspectives. EuroPCR. Paris, France (24 - 27 May 2005).
29. LIU X, HUANG Y, HANET C et al.: Study of antirestenosis with the BiodivYsio dexamethasone-eluting stent (STRIDE): a first-in-human multicenter pilot trial. Catheter Cardiovasc. Interv. (2003) 60(2):172-178; discussion 179.
30. DE SCHEERDER I: The Abbott vascular devices dexamethasone eluting stent: from STRIDE to the 'real-world' SAFE registry. Transcatheter Therapeutics Scientific Sessions, Washington, DC, USA (2003).
31. LEFER AM, SCALIA R, LEFER DJ: Vascular effects of HMG CoA-reductase inhibitors (statins) unrelated to cholesterol lowering: new concepts for cardiovascular disease. Cardiovasc. Res. (2001) 49(2):281-287.
32. INDOLFI C, CIOPPA A, STABILE E et al.: Effects of hydroxymethylglutaryl coenzyme A reductase inhibitor simvastatin on smooth muscle cell proliferation in vitro and neointimal formation in vivo after vascular injury. J. Am. Coll. Cardiol. (2000) 35(1):214-221.
33. TANABE K, ISHIYAMA H, VAN DER GIESSEN W, SERRUYS PW: Terumo statin releasing stent (preclinical results). In: Drug-Eluting Stents. Gershlick A (Ed.), Taylor and Francis Group, London, UK (2005):313-321.
34. HEUBLEIN B, ROHDE R, KAESE V et al.: Biocorrosion of magnesium alloys: a new principle in cardiovascular implant technology? Heart (2003) 89(6):651-656.
35. VAN DER GIESSEN WJ, LINCOFF AM, SCHWARTZ RS et al.: Marked inflammatory sequelae to implantation of biodegradable and nonbiodegradable polymers in porcine coronary arteries. Circulation (1996) 94(7):1690-1697.
36. DI MARIO C, GRIFFITHS H, GOKTEKIN O et al.: Drug-eluting bioabsorbable magnesium stent. J. Interv. Cardiol. (2004) 17(6):391-395.
37. ERBEL R: Coronary results of the first absorbable metal stent: The Progress-I trial. 55th Annual Scientific Session of the American College of Cardiology. Atlanta, GA, USA (11 - 16 March 2006).
38. SERRUYS PW: Emerging technology 1. Stents - new drugs. 55th Annual Scientific Session of ACC. Atlanta, GA USA, 11 - 14 March (2006).
39. MIDDLETON J, TIPTON A: Synthetic biodegradable polymers as orthopedic devices. Biomaterials (2000) 21(23):2335-2346.
40. 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(15):1330-1340.
41. TAMAI H, IGAKI K, KYO E et al.: Initial and 6-month results of biodegradable poly-1-lactic acid coronary stents in humans. Circulation (2000) 102(4):399-404.
42. GRUBE E, HAUPTMANN KE, BUELLESFELD L, LIM V, ABIZAID A: Six-month results of a randomized study to evaluate safety and efficacy of a Biolimus A9™ eluting stent with a biodegradable polymer coating. EuroIntervention (2005) 1:53-57.
43. COSTA RA, LANSKY AJ, MINTZ GS et al.: Angiographic results of the first human experience with everolimus-eluting stents for the treatment of coronary lesions (the FUTURE I trial). Am. J. Cardiol. (2005) 95(1):113-116.
44. GRUBE E, SONODA S, IKENO F et al.: Six- and twelve-month results from first human experience using everolimus-eluting stents with bioabsorbable polymer. Circulation (2004) 109(18):2168-2171.
45. GRUBE E: FUTURE II: Multicenter evaluation of the bioabsorbable polymer-based everolimus-eluting stent. 15th Annual Transcatheter Cardiovascular Therapeutics. Washington, DC, USA (15 - 19 September 2003).
46. GAMBHIR DS: The Infinnium polymer-based paclitaxel drug-eluting stent: Results from real world clinical trials SIMPLE 1 and SIMPLE 2. Transcatheter Cardiovascular Therapeutics 2004. Washington, DC, USA (22 October 2004).
47. LELE S: Heparin sirolimus stent. EuroPCR 2006. Paris, France (16-19 May 2006).
48. SERRUYS PW, SIANOS G, ABIZAID A et al.: The effect of variable dose and release kinetics on neointimal hyperplasia using a novel paclitaxel-eluting stent platform: the Paclitaxel In-Stent Controlled Elution Study (PISCES). J. Am. Coll. Cardiol. (2005) 46(2):253-260.
49. AOKI J, ONG AT, ABIZAID A et al.: One-year clinical outcome of various doses and pharmacokinetic release formulations of paclitaxel eluted from an erodable polymer. Insight in the Paclitaxel In-Stent Controlled Elution Study (PISCES). EuroIntervention (2005) 2:165-172.
50. KAUL U: Erodablepolymer-reservoir paclitaxel drug eluting stents II: cobalt chromium platforms in complex lesions Transcatheter Cardiovascular Therapeutics 2004. Washington, DC, USA (22 October 2004).
51. SERRUYS PW: The new CoStar™ stent: 12 month results with the new DES technology. EuroPCR. Paris, France (24 - 27 May 2005).
52. WIJNS W.. CoStar™ Paclitaxel-eluting stent: relevance in drug-eluting stent clinical data landscape. EuroPCR 2006. Paris, France (16 - 19 May 2006).
53. DAWKINS K: The Eurostar trial. EuroPCR. Paris, France (24 - 27 May 2005).
54. GERSHLICK A, DE SCHEERDER I, CHEVALIER B et al.: Inhibition of restenosis with a paclitaxel-eluting, polymer-free coronary stent: the European evaLUation of pacliTaxel Eluting Stent (ELUTES) trial. Circulation (2004) 109(4):487-493.
55. PARK SJ, SHIM WH, HO DS et al.: A paclitaxel-eluting stent for the prevention of coronary restenosis. N. Engl. J. Med. (2003) 348(16):1537-1545.
56. LANSKY AJ, COSTA RA, MINTZ GS et al.: Non-polymer-based paclitaxel-coated coronary stents for the treatment of patients with de novo coronary lesions: angiographic follow-up of the DELIVER clinical trial. Circulation (2004) 109(16):1948-1954.
57. VIRMANI R. Atrium medical bioabsorbable oil based delivery of a sirolimus analogue from a stent and balloon. Transcatheter Cardiovascular Therapeutics 2005. Washington, DC, USA (17 - 21 October 2005).
58. WINDECKER, S, MAYER I, DE PASQUALE G et al.: Stent coating with titanium-nitride-oxide for reduction of neointimal hyperplasia. Circulation (2001) 104(8):928-933.
59. WINDECKER S, SIMON R, LINS M et al.: Randomized comparison of a titanium-nitride-oxide-coated stent with a stainless steel stent for coronary revascularization: the TiNOX trial. Circulation (2005) 111(20):2617-2622.
60. WIENEKE H, DIRSCH O, SAWITOWSKI T et al.: Synergistic effects of a novel nanoporous stent coating and tacrolimus on intima proliferation in rabbits. Catheter Cardiovasc. Interv. (2003) 60(3):399-407.
61. KOLLUM M, FARB A, SCHREIBER R et al.: Particle debris from a nanoporous stent coating obscures potential antiproliferative effects of tacrolimus-eluting stents in a porcine model of restenosis. Catheter Cardiovasc. Interv. (2005) 64(1):85-90.
62. GERCKENS U, BUELLESFELD L, HORSKOTTE D et al.: Evaluation of a tacrolimus-eluting coronary stent with nanoporous ceramic coating in treatment of native coronary artery lesions: Phase I and II of the PRESENT study. J. Am. Coll. Cardiol. (2003) 41(Suppl. A):7A.
63. HAUSLEITER J, KASTRATI A, WESSELY R et al.: Prevention of restenosis by a novel drug-eluting stent system with a dose-adjustable, polymer-free, on-site stent coating. Eur. Heart J. (2005) 26(15):1475-1481.
64. MORICE MC, BESTEHORN HP, CARRIE D et al.: Direct stenting of the de novo coronary stenoses with tacrolimus-eluting versus carbon-coated carbostents. The randomized JUPITER II trial. EuroIntervention (2006) 2:45-52.
65. MCFADDEN EP, STABILE E, REGAR E et al.: Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet (2004) 364(9444):1519-1521.
66. NEBEKER JR, VIRMANI R, BENNETT CL et al: Hypersensitivity cases associated with drug-eluting coronary stents: a review of available cases from the Research on Adverse Drug Events and Reports (RADAR) project. J Am. Coll Cardiol. (2006) 47(1):175-181.
67. SAIA F, LEMOS PA, ARAMPATZIS CA et al.: Routine sirolimus eluting stent implantation for unselected in-stent restenosis: insights from the rapamycin eluting stent evaluated at Rotterdam Cardiology Hospital (RESEARCH) registry. Heart (2004) 90(10):1183-1188.
68. NEUMANN FJ, DESMET W, GRUBE E et al.: Effectiveness and safety of sirolimus-eluting stents in the treatment of restenosis after coronary stent placement. Circulation (2005) 111(16):2107-2111.
69. KASTRATI A, MEHILLI J, VON BECKERATH N et al.: ISAR-DESIRE: drug-eluting stents for in-stent restenosis. European Society of Cardiology Congress. Munich, Germany (28 August - 1 September 2004).
70. LEMOS PA, HOYE A, GOEDHART D et al.: Clinical, angiographic, and procedural predictors of angiographic restenosis after sirolimus-eluting stent implantation in complex patients: an evaluation from the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) study. Circulation (2004) 109(11):1366-1370.
71. COLOMBO A, MOSES JW. MORICE MC et al.: Randomized study to evaluate sirolimus-eluting scents implanted at coronary bifurcation lesions. Circulation (2004) 109(10):1244-1249.
72. SHARMA SK: Simultaneous kissing drug-eluting stent technique for percutaneous treatment of bifurcation lesions in large-size vessels. Catheter Cardiovasc. Interv. (2005) 65(1):10-16.
73. NAKAMURA S, MUTHUSAMY TS, BAE JH et al.: Impact of sirolimus-eluting stent on the outcome of patients with chronic total occlusions. Am. J. Cardiol. (2005) 95(2):161-166.
74. WERNER GS, KRACK A, SCHWARZ G et al.: Prevention of lesion recurrence in chronic total coronary occlusions by paclitaxel-eluting stents. J. Am. Coll. Cardiol. (2004) 44(12):2301-2306.
75. SERRUYS PW, ONG AT, COLOMBO A et al.: Arterial revascularization therapies study part II: sirolimus-eluting stents for the treatment of patients with multivessel de novo coronary artery lesions. 54th American College of Cardiology Annual Scientific Session. Orlando, FL, USA (6 March 2005).
76. KAPUR A, MALIK IS, BAGGER JP et al.: The Coronary Artery Revascularisation in Diabetes (CARDia) trial: background, aims, and design. Am. Heart J. (2005) 149(1):13-19.
77. ONG AT, SERRUYS PW, MOHR FW et al.: The Synergy Between Percutaneous Coronary Intervention with TAXus™ and Cardiac Surgery (SYNTAX) Study: design, rationale and run-in phase. Am. Heart J. (2006). 151(6):1194-1204.
78. SERRUYS PW: Drug-eluting scents: results from clinical trials. The PISCES trials. 55th Annual Scientific Session of the American College of Cardiology. Atlanta, GA, USA (11-16 March 2006).