A novel platinum chromium everolimus-eluting stent for the treatment of coronary artery disease

Biologics: Targets and Therapy

Volumn 7, Issue 1, 2013, Pages 149-159

  Bennett, Johan ^a   Dubois, Christophe ^a  

^a UNIVERSITY HOSPITALS LEUVEN   (Belgium)

Author keywords

Drug eluting stent; Promus Element; Restenosis; Synergy

Indexed keywords

CHROMIUM; EVEROLIMUS; PACLITAXEL; PLATINUM; RAPAMYCIN; UMIROLIMUS; ZOTAROLIMUS;

ANTIPROLIFERATIVE ACTIVITY; ATHEROSCLEROSIS; BARE METAL STENT; CARDIOVASCULAR RISK; CORONARY ARTERY DISEASE; CORONARY STENT; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG ELUTING STENT; DRUG MECHANISM; DRUG PROTEIN BINDING; DRUG RELEASE; DRUG SAFETY; HEART DEATH; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HUMAN; IN-STENT RESTENOSIS; LONGITUDINAL STENT DEFORMATION; MEDICAL DEVICE COMPLICATION; NONHUMAN; OUTCOME ASSESSMENT; PERCUTANEOUS CORONARY INTERVENTION; REVIEW; RISK ASSESSMENT; RISK FACTOR; STENT THROMBOSIS;

EID: 84879324095     PISSN: 11775475     EISSN: 11775491     Source Type: Journal    
DOI: 10.2147/BTT.S34939     Document Type: Review

References (66)

1. The World Health Organization. The top ten causes of death fact sheet. 2004. Available at: http://www.who.int/mediacentre/factsheets/fs310/en/index.html. Accessed January 18, 2013.
2. Lloyd-Jones D, Adams RJ, Brown TM, et al. Executive summary: heart disease and stroke statistics - 2010 update: a report from the American Heart Association. Circulation. 2010;121(7):948-954.
3. Lioyd-Jones DM, Larson MG, Beiser A, Levy D. Lifetime risk of developing coronary heart disease. Lancet 1999;353(9147):89-92.
4. Serruys PW, Kutryk MJ, Ong ATL. Coronary-artery stents. N Engl J Med. 2006;354(5):483-495.
5. Moliterno DJ. Healing Achilles - sirolimus versus paclitaxel. N Engl J Med. 2005;353(7):724-727.
6. Arjomand H, Turi Z, McCormick D, Goldberg S. Percutaneous coronary intervention: historical perspectives, current status, and future direction. Am Heart J. 2003;146(5):787-796.
7. Hill RA, Dundar Y, Bakhai A, Dickson R, Walley T. Drug-eluting stents: an early systematic review to inform policy. Eur Heart J. 2004;25(11):902-919.
8. 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.
9. Tsimikas S. Drug-eluting stents and late adverse clinical outcomes: lessons learned, lessons awaited. J Am Coll Cardiol. 2006;47(10):2112-2115.
10. Silber S, Albertsson P, Aviles FF, et al. Guidelines for percutaneous interventions. The task force for percutaneous coronary interventions of the European Society of Cardiology. Eur Heart J. 2005;26(8):804-847.
11. Iakovou 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.
12. Menown IB, Noad R, Garcia EJ, Meredith I. The platinum chromium element stent platform: from alloy, to design, to clinical practice. Adv Ther. 2010;27(3):129-141.
13. Kastrati A, Mehilli J, Dirschinger J, et al. Intracoronay stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO) trial. Circulation. 2001;103(23):2816-2821.
14. Kastrati A, Schomig A, Dirschinger J, et al. Increased risk of restenosis after placement of gold-coated stents. Circulation. 2000;101(21):2478-2483.
15. O'Brien BJ, Stinson JS, Larsen SR, Eppihimer MJ, Carroll WM. A platinum-chromium steel for cardiovascular events. Biomaterials. 2010;31(14):3755-3761.
16. Stettler C, Wandel S, Allemann S, et al. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007;370(9591):937-948.
17. Kedhi E, Joesoef KS, McFadden E, et al. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial. Lancet. 2010;375(9710):201-209.
18. Stone GW, Rizvi A, Newman W, et al. Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. N Engl J Med. 2010;362(18):1663-1674.
19. Jensen LO, Thayssen P, Hansen HS, et al. Randomized comparison of everolimus-eluting and sirolimus-eluting stents in patients treated with percutaneous coronary intervention: the Scandinavian Organization for Randomized Trials with Clinical Outcome IV (SORT OUT IV). Circulation. 2012;125(10):1246-1255.
20. Bangalore S, Kumar S, Fusaro M, et al. Short-and long-term outcomes with drug-eluting and bare-metal coronary stents: a mixed-treatment comparison analysis of 117 762 patient-years of follow-up from randomized trials. Circulation. 2012;125(23):2873-2891.
21. Camenzind E, Wijns W, Mauri L, et al. Stent thrombosis and major clinical events at 3 years after zotarolimus-eluting or sirolimus-eluting coronary stent implantation: a randomised, multicentre, open-label, controlled trial. Lancet. 2012;380(9851):1396-1405.
22. Leon MB, Nikolsky E, Cutlip DE, et al. Improved late clinical safety with zotarolimus-eluting stents compared with paclitaxel-eluting stents in patients with de novo coronary lesions: 3-year follow-up from the ENDEAVOR IV (Randomized Comparison of Zotarolimus-and Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease) trial. JACC Cardiovasc Interv. 2010;3(10):1043-1050.
23. Serruys P, Buszman P, Linke A, et al. 5-year follow-up from a prospective, randomized trial of biolimus A9-eluting stents with a biodegradable polymer vs sirolimus-eluting stents with a durable polymer-final report of the LEADERS study [abstract]. J Am Coll Cardiol. 2012; 60(Suppl 17):B13-B14.
24. Rogers CD. Optimal stent design for drug delivery. Rev Cardiovasc Med. 2004;5(Suppl 2):S9-S15.
25. Kotani J, Awata M, Nanto S, et al. Incomplete neointimal coverage of sirolimus-eluting stents: angioscopic findings. J Am Coll Cardiol. 2006;47(10):2108-2111.
26. 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(8):2435-2441.
27. Daemen J, Wenaweser P, Tsuchida K, et al. Early and late stent t{stroke}hrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet. 2007;369(9562):667-678.
28. King SB 3rd, Smith SC Jr, Hirshfeld JW Jr, et al. 2007 focused update of the 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. J Am Coll Cardiol. 2008;51(2):172-209.
29. Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS); European Association for Percutaneous Cardio-vascular Interventions (EAPCI), Wijns W, Kolh P, Danchin N, et al. Guidelines on myocardial revascularization. Eur Heart J. 2010; 31(20): 2501-2555.
30. Windecker S, Serruys PW, Wandel S, et al. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial. Lancet. 2008;372(9644):1163-1173.
31. Krucoff MW, Kereiakes DJ, Petersen JL, et al. A novel bioresorbable polymer paclitaxel-eluting stent for the treatment of single and multivessel coronary disease: primary results of the COSTAR (Cobalt Chromium Stent With Antiproliferative for Restenosis) II study. J Am Coll Cardiol. 2008;51(16):1543-1552.
32. Grube E, Schofer J, Hauptmann KE, et al. Novel paclitaxel-eluting stent with an ultrathin abluminal biodegradable polymer 9-month outcomes with the JACTAX HD stent. JACC Cardiovasc Interv. 2010;3(4):431-438.
33. Stefanini GG, Byrne RA, Serruys PW, et al. Biodegradable polymer drug-eluting stents reduce the risk of stent thrombosis at 4 years in patients undergoing percutaneous coronary intervention: a pooled analysis of individual patient data from the ISAR-TEST 3, ISAR-TEST 4, and LEADERS randomized trials. Eur Heart J. 2012;33(10): 1214-1222.
34. Lupi A, Rognoni A, Secco GG, et al. Biodegradable versus durable polymer drug eluting stents in coronary artery disease: Insights from a meta-analysis of 5834 patients. Eur J Prev Cardiol. 2013. [Epub November 14, 2012.]
35. Carrie D, Berland B, Verheye S, et al. A multicenter randomized trial comparing amphilimus-with paclitaxel-eluting stents in de novo native coronary artery lesions. J Am Coll Cardiol. 2012; 59(15):1371-1376.
36. Schuler W, Sedrani R, Cottens S, et al. SDZ RAD, a new rapamycin derivative: pharmacological properties in vitro and in vivo. Transplantation. 1997;64(1):36-42.
37. Marx SO, Marks AR. Bench to bedside: the development of rapamycin and its application to stent restenosis. Circulation. 2001;104(8): 852-855.
38. Carter AJ. TOR of the cell cycle: Are there important implications for diabetics in the era of the drug-eluting stent? Catheter Cardiovasc Interv. 2004;61(2):233-236.
39. Waksman R, Pakala R, Baffour R, et al. Optimal dosing and duration of oral everolimus to inhibit in-stent neointimal growth in rabbit iliac arteries. Cardiovasc Revasc Med. 2006;7(3):179-184.
40. Verheye S, Martinet W, Kockx MM, et al. Selective clearance of macrophages in atherosclerotic plaques by autophagy. J Am Coll Cardiol. 2007;49(6):706-715.
41. Kahan BD, Wong RL, Carter C, et al. A phase I study of a 4-week course of SDZ-RAD (RAD) quiescent cyclosporine-prednisone-treated renal transplant recipients. Transplantation. 1999;68(8):1100-1106.
42. Stone GW, Midei M, Newman W, et al. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. JAMA. 2008;299(16): 1903-1913.
43. Baber U, Mehran R, Sharma SK, et al. Impact of the everolimus-eluting stent on stent thrombosis: a meta-analysis of 13 randomized trials. J Am Coll Cardiol. 2011;58(15):1569-1577.
44. Palmerini T, Kirtane AJ, Serruys PW, et al. Stent thrombosis with everolimus-eluting stents: meta-analysis of comparative randomized controlled trials. Circ Cardiovasc Interv. 2012;5(3):357-364.
45. Xie X, Guidoin R, Nutley M, Zhang Z. Fluoropassivation and gelatin sealing of polyester arterial prostheses to skip preclotting and constrain the chronic inflammatory response. J Biomed Mater Res B Appl Biomater. 2010;93(2):497-509.
46. Gutiérrez-Chico JL, van Geuns RJ, Regar E, et al. Tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent vs a fluoropolymer-coated everolimus-eluting stent at 13-month follow-up: an optical coherence tomography substudy from the RESOLUTE All Comers trial. Eur Heart J. 2011;32(19):2454-2463.
47. Chen Y-L, Foss A, Eppihimer M, et al. Characterization of in vivo poly(dl-lactic-co-glycolic acid) bioabsorption from a drug-eluting stent. EuroIntervention. 2012;8(Suppl N):N043.
48. Stone GW, Teirstein PS, Meredith IT, et al. A prospective randomized evaluation of a novel everolimus-eluting stent: the PLATINUM (a prospective, randomized, multicenter trial to assess an everlimuseluting coronary stent system [Promus Element] for the treatment of up to two de novo coronary artery lesions) trial. J Am Coll Cardiol. 2011;57(16):1700-1708.
49. Stone GW, Teirstein PS, Meredith IT, et al. Two-year results of the PLATINUM randomized trial comparing platinum chromium promus element and cobalt chromium PROMUS/XIENCE V everolimus-eluting stents in de novo coronary artery lesions. J Am Coll Cardiol. 2012; 59(13 Suppl 1):E323.
50. Stone GW, Ellis SG, Cannon L, et al. Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease: a randomized controlled trial. JAMA. 2005;294(10):1215-1223.
51. Cannon L, Kereiakes DJ, Mann T, et al. A prospective evaluation of the safety and efficacy of TAXUS Element paclitaxel-eluting coronary stent implantation for the treatment of de novo coronary artery lesions in small vessels: The PERSEUS Small Vessel Trial. EuroIntervention. 2011;6(8):920-927.
52. Cannon LA, Simon DI, Kereiakes D, et al. The XIENCE nano everolimus eluting coronary stent system for the treatment of small coronary arteries: The SPIRIT small vessel trial. Catheter Cardiovasc Interv. 2012;80(4):546-553.
53. Wykrzykowska JJ, Serruys PW, Onuma Y, et al. Impact of vessel size on angiographic and clinical outcomes of revascularization with biolimus-eluting stent with biodegradable polymer and sirolimus-eluting stent with durable polymer, the LEADERS trial substudy. JACC Cardiovasc Interv. 2009;2(9):861-870.
54. Meredith I, Teirstein P, Stone G, et al. Two-year results of the PLATINUM small vessel trial: evaluation of a 2.25 mm platinum chromium everolimus-eluting stent in de novo coronary artery lesions. EuroIntervention. 2012;8(Suppl N):N161.
55. Kim YH, Park SW, Lee SW, et al. Sirolimus-eluting stent versus paclitaxel-eluting stent for patients with long coronary artery disease. Circulation. 2006;114(20):2148-2153.
56. Serruys PW, Ong AT, 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):58-65.
57. Serruys PW, Ruygrok P, Neuzner J, et al. A randomised comparison of an everolimus-eluting coronary stent with a paclitaxel-eluting coronary stent: the SPIRIT II trial. EuroIntervention. 2006;2(3):286-294.
58. Meredith IT, Whitbourn R, Scott D, et al. PLATINUM QCA: a prospective, multicentre study assessing clinical, angiographic, and intravascular ultrasound outcomes with the novel platinum chromium thin-strut PROMUS Element everolimus-eluting stent in de novo coronary stenoses. EuroIntervention. 2011;7(1):84-90.
59. Meredith IT, Verheye S, Dubois CL, et al. Primary endpoint results of the EVOLVE trial: a randomized evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent. J Am Coll Cardiol. 2012;59(15):1362-1370.
60. Verheye S, Meredith IT, Weissman NJ, et al. Six-month IVUS and 12-month clinical outcomes in the EVOLVE FHU trial: a randomized evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting stent. EuroIntervention. 2012;8(Suppl N):N42.
61. Hanratty CG, Walsh SJ. Longitudinal compression: a "new" complication with modern coronary stent platforms time to think beyond deliverability? EuroIntervention. 2011;7(7):872-877.
62. Williams PD, Mamas MA, Morgan KP, et al. Longitudinal stent deformation: a retrospective analysis of frequency and mechanisms. EuroIntervention. 2012;8(2):267-274.
63. Mamas MA, Williams PD. Longitudinal stent deformation: insights on mechanisms, treatments and outcomes from the Food and Drug Administration Manufacturer and User Facility Device Experience database. EuroIntervention. 2012;8(2):196-204.
64. Prabhu S, Schikorr T, Mahmoud T, Jacobs J, Potgieter A, Simonton C. Engineering assessment of the longitudinal compression behaviour of contemporary coronary stents. EuroIntervention. 2012;8(2):275-281.
65. Ormiston JA, Webber B, Webster MW. Stent longitudinal integrity. bench insights into a clinical problem. JACC Cardiovasc Interv. 2011;4(12):1310-1317.
66. Kereiakes DJ, Popma JJ, Cannon LA, et al. Longitudinal stent deformation: quantitative coronary angiographic analysis from the PERSEUS and PLATINUM randomised controlled clinical trials. EuroIntervention. 2012;8(2):187-195.