Advances in drug eluting stents - Focus on the Endeavor® zotarolimus stent

Medical Devices: Evidence and Research

Volumn 2, Issue 1, 2009, Pages 1-8

  Bridges, Jonathan ^a   Cutlip, Donald ^a  

^a BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

Author keywords

Drug eluting stent; Endeavor stent; Zotarolimus stent

Indexed keywords

ACUTE CORONARY SYNDROMES; CAUSES OF DEATH; CLOPIDOGREL; CORONARY ARTERIES; CORONARY ARTERY DISEASE; DRUG-ELUTING STENTS; NEOINTIMAL HYPERPLASIA; PERCUTANEOUS CORONARY INTERVENTION; PHARMACOLOGICAL AGENTS; RESTENOSIS; STENTING;

DISEASES;

HEART;

'TAXUS'; ACETYLSALICYLIC ACID; CLOPIDOGREL; CYPHER; ENDEAVOR; ENDEAVOR RESOLUTE; EVEROLIMUS; PACLITAXEL; POLYMER; RAPAMYCIN; UNCLASSIFIED DRUG; ZOTAROLIMUS;

ACUTE CORONARY SYNDROME; ARTERY INTIMA PROLIFERATION; ARTICLE; BARE METAL STENT; CLINICAL TRIAL; CORONARY ARTERY DISEASE; DRUG ELUTING STENT; DRUG RELEASE; FEASIBILITY STUDY; FOLLOW UP; HUMAN; IN-STENT RESTENOSIS; PERCUTANEOUS CORONARY INTERVENTION; REVASCULARIZATION; STENT THROMBOSIS;

EID: 77953365666     PISSN: None     EISSN: 11791470     Source Type: Journal    
DOI: None     Document Type: Article

References (59)

1. Minino AM, Heron MP, Murphy SL, Kochanek KD. Deaths: final data for 2004. Natl Vital Stat Rep. 2007;55:1-119.
2. Tan K, Sulke N, Taub N, Sowton E. Clinical and lesion morphologic determinants of coronary angioplasty success and complications: current experience. J Am Coll Cardiol. 1995;25:855-865.
3. Lincoff AM, Popma JJ, Ellis SG, Hacker JA, Topol EJ. Abrupt vessel closure complicating coronary angioplasty: clinical, angiographic and therapeutic profile. J Am Coll Cardiol. 1992;19:926-35.
4. Seshadri N, Whitlow PL, Acharya N, Houghtaling P, Blackstone EH, Ellis SG. Emergency coronary artery bypass surgery in the contemporary percutaneous coronary intervention era. Circulation. 2002;106:2346-5230.
5. Mehran R, Mintz GS, Popma JJ, et al. Mechanisms and results of balloon angioplasty for the treatment of in-stent restenosis. Am J Cardiol. 1996;78:618-622.
6. Mintz GS, Popma JJ, Hong MK, et al. Intravascular ultrasound to discern device-specific effects and mechanisms of restenosis. Am J Cardiol. 1996;78:18-22.
7. Serruys PW, Strauss BH, Beatt KJ, et al. Angiographic follow-up after placement of a self-expanding coronary-artery stent. N Engl J Med. 1991;324:13-17.
8. Serruys PW, de Jaegere P, Kiemeneij F, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994;331:489-495.
9. Fischman DL, Leon MB, Baim DS, et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl J Med. 1994;331:496-501.
10. Moussa I, Di Mario C, Di Francesco L, Reimers B, Blengino S, Colombo A. Subacute stent thrombosis and the anticoagulation controversy: changes in drug therapy, operator technique, and the impact of intravascular ultrasound. Am J Cardiol. 1996;78:13-17.
11. Moussa I, Oetgen M, Roubin G, et al. Effectiveness of clopidogrel and aspirin versus ticlopidine and aspirin in preventing stent thrombosis after coronary stent implantation. Circulation. 1999;2364-2366.
12. De Servi S, Repetto S, Klugmann S, et al. Stent thrombosis: incidence and related factors in the R.I.S.E. Registry (Registro Impianto Stent Endocoronarico). Catheter Cardiovasc Interv. 1999;46:13-18.
13. Leon M, Baim D, Popma J, et al. A clinical trial comparing three antithrombotic-drug regimens after coronary-artery stenting. N Engl J Med. 339:1665-1671.
14. Schömig A, Neumann F-J, Kastrati A, et al. A randomized comparison of antiplatelet and anticoagulant therapy after the placement of coronary-artery stents. N Engl J Med. 1996;334:1084-1089.
15. Cutlip DE, Baim DS, Ho KK, et al. Stent thrombosis in the modern era: a pooled analysis of multicenter coronary stent clinical trials. Circulation. 2001;103:1967-1971.
16. Cutlip DE, Chauhan MS, Baim DS, et al. Clinical restenosis after coronary stenting: perspectives from multicenter clinical trials. J Am Coll Cardiol. 2002;40:2082-2089.
17. Cutlip DE, Chhabra AG, Baim DS, et al. Beyond restenosis: five-year clinical outcomes from second-generation coronary stent trials. Circulation. 2004;110:1226-1230.
18. Mauri L, O'Malley AJ, Cutlip DE, et al. Effects of stent length and lesion length on coronary restenosis. Am J Cardiol. 2004;93:1340-6, A5.
19. Topol EJ, Ellis SG, Fishman J, et al. Multicenter study of percutaneous transluminal angioplasty for right coronary artery ostial stenosis. J Am Coll Cardiol. 1987;9:1214-1218.
20. Mathias DW, Mooney JF, Lange HW, Goldenberg IF, Gobel FL, Mooney MR. Frequency of success and complications of coronary angioplasty of a stenosis at the ostium of a branch vessel. Am J Cardiol. 1991;67:491-495.
21. Berger PB, Holmes DR Jr, Ohman EM, et al. Restenosis, reocclusion and adverse cardiovascular events after successful balloon angioplasty of occluded versus nonoccluded coronary arteries. Results from the Multicenter American Research Trial With Cilazapril After Angioplasty to Prevent Transluminal Coronary Obstruction and Restenosis (MARCATOR). J Am Coll Cardiol. 1996;27:1-7.
22. Kitazume H, Ichiro K, Iwama T, Ageishi Y. Repeat coronary angioplasty as the treatment of choice for restenosis. Am Heart J. 1996;132:711-715.
23. Waksman R, Bhargava B, Mintz G, et al. Late total occlusion after intracoronary brachytherapy for patients with in-stent restenosis. J Am Coll Cardiol. 2000;36:65-68.
24. 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;346:1773-1780.
25. Serruys PW, Degertekin M, Tanabe K, et al. Intravascular ultrasound findings in the multicenter, randomized, double-blind RAVEL (RAndomized study with the sirolimus-eluting VElocity balloonexpandable stent in the treatment of patients with de novo native coronary artery Lesions) trial. Circulation. 2002;106:798-803.
26. Fajadet J, Morice MC, Bode C, et al. Maintenance of long-term clinical benefit with sirolimus-eluting coronary stents: three-year results of the RAVEL trial. Circulation. 2005;111:1040-1044.
27. Moses JW, Leon MB, Popma JJ, et al. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003;349:1315-1323.
28. 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;109:1942-7.
29. Pfisterer M, Brunner-La Rocca HP, Buser PT, et al. Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-metal stents. J Am Coll Cardiol. 2006;48:2584-2591.
30. Camenzind E, Steg PG, Wijns W. Stent thrombosis late after implantation of first-generation drug-eluting stents: a cause for concern. Circulation. 2007;115:1440-55; discussion 1455.
31. Nordmann AJ, Briel M, Bucher HC. Mortality in randomized controlled trials comparing drug-eluting vs. bare metal stents in coronary artery disease: a meta-analysis. Eur Heart J. 2006;27:2784-2814.
32. Mauri L, Hsieh WH, Massaro JM, Ho KK, D'Agostino R, Cutlip DE. Stent thrombosis in randomized clinical trials of drug-eluting stents. N Engl J Med. 2007;356:1020-1029.
33. Farb A, Boam AB. Stent thrombosis redux - the FDA perspective. N Engl J Med. 2007;356:984-987.
34. Daemen J, Wenaweser P, Tsuchida K, et al. 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. 2007;369:667-678.
35. Finn AV, Joner M, Nakazawa G, et al. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation. 2007;115:2435-2441.
36. Luscher TF, Steffel J, Eberli FR, et al. Drug-eluting stent and coronary thrombosis: biological mechanisms and clinical implications. Circulation. 2007;115:1051-1058.
37. Virmani R, Guagliumi G, Farb A, et al. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation. 2004;109:701-705.
38. Farb A, Burke AP, Kolodgie FD, Virmani R. Pathological mechanisms of fatal late coronary stent thrombosis in humans. Circulation. 2003;108:1701-1706.
39. Maisel WH. Unanswered questions - drug-eluting stents and the risk of late thrombosis. N Engl J Med. 2007;356:981-984.
40. Mauri L, Orav EJ, Kuntz RE. Late loss in lumen diameter and binary restenosis for drug-eluting stent comparison. Circulation. 2005;111:3435-3442.
41. Schwartz RS, van der Giessen WJ, Holmes DR Jr. Biomimicry, vascular restenosis and coronary stents. Semin Interv Cardiol. 1998;3:151-156.
42. Hayward JA, Durrani AA, Shelton CJ, Lee DC, Chapman D. Biomembranes as models for polymer surfaces. III. Characterization of a phosphorylcholine surface covalently bound to glass. Biomaterials. 1986;7:126-131.
43. Lewis AL, Tolhurst LA, Stratford PW. Analysis of a phosphorylcholinebased polymer coating on a coronary stent pre- and post-implantation. Biomaterials. 2002;23:1697-1706.
44. Virmani R, Guagliumi G, Farb A, et al. Localized Hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent should we be cautious? Circulation. 2004;109:701-705.
45. Whelan DM, van der Giessen WJ, Krabbendam SC, et al. Biocompatibility of phosphorylcholine coated stents in normal porcine coronary arteries. Heart. 2000;83:338-345.
46. Malik N, Gunn J, Shepherd L, Crossman DC, Cumberland DC, Holt CM. Phosphorylcholine-coated stents in porcine coronary arteries: in vivo assessment of biocompatibility. J Invasive Cardiol. 2001;13:193-201.
47. Kandzari DE, Leon MB. Overview of pharmacology and clinical trials program with the zotarolimus-eluting endeavor stent. J Interv Cardiol. 2006;19:405-413.
48. Burke SE, Kuntz RE, Schwartz LB. Zotarolimus (ABT-578) eluting stents. Adv Drug Deliv Rev. 2006;58:437-446.
49. Meredith IT, Ormiston J, Whitbourn R, et al. Four-year clinical follow-up after implantation of the endeavor zotarolimus-eluting stent: ENDEAVOR I, the first-in-human study. Am J Cardiol. 2007;100:56M-61M.
50. Meredith IT Ormiston J, Whitbourn R, et al. First-in-human study of the Endeavor ABT-578-eluting phosphorylcholine-encapsulated stent system in de novo native coronary artery lesions: Endeavor I trial. EuroIntervention. 2005;1:157-164.
51. Fajadet J, Wijns W, Laarman GJ, et al. Randomized, doubleblind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine- encapsulated stent for treatment of native coronary artery lesions: clinical and angiographic results of the ENDEAVOR II trial. Circulation. 2006;114:798-806.
52. Fadajet J. EuroPCR May 2008.
53. Kandzari D, Leon M, Popma J, et al. Comparison of zotarolimus-eluting and sirolimus-eluting stents in patients with native coronary artery disease. J Am Coll Cardiol. 2006;48:2440-2447.
54. Leon M, Endeavor IV: A randomized comparison of a zotarolimuseluting stent and a paclitaxel-eluting stent in patients with coronary artery disease; TCT Conference; Oct 2007.
55. Meredith I. EuroPCR May 2008.
56. Rivero, F, Moreno R, Barreales L, et al. Lower levels of in-stent late loss are not associated with the risk of stent thrombosis in patients receiving drug-eluting stents. EuroIntervention. 2008;4:124-132.
57. Udipi, K, Melder, R, et al. The Next Generation Endeavor Resolute Stent: Role of the Biolinx Polymer System. EuroIntervention. 2007;3:137-139.
58. Meredith I, Worthley S, Whitbourn R, et al. The next-generation Endeavor Resolute stent: 4-month clinical and angiographic results from the Endeavor Resolute first-in-man trial. EuroIntervtion. 2007;3:50-53.
59. Stone GW, Midei M, Newman W, et al. Comparison of an everolimuseluting stent and a paclitaxel-eluting stent in patients with a coronary artery disease: A randomized trial. JAMA. 2008;299:1903-1913.