Current status of the Xience V® everolimus-eluting coronary stent system

Expert Review of Cardiovascular Therapy

Volumn 8, Issue 10, 2010, Pages 1363-1374

  Claessen, Bimmer E ^a,b   Caixeta, Adriano ^b   Henriques, José Ps ^a   Piek, Jan J ^a  

^a UNIVERSITY OF AMSTERDAM   (Netherlands)

^b CARDIOVASCULAR RESEARCH FOUNDATION   (United States)

Author keywords

drug eluting stent; everolimus; percutaneous coronary intervention; Xience V

Indexed keywords

CHROMIUM; COBALT; ENDEAVOR; ENDEAVOR RESOLUTE; EVEROLIMUS; LIBERTE; PACLITAXEL; RAPAMYCIN; TAXUS ELEMENT; TAXUS EXPRESS; UNCLASSIFIED DRUG; ZOTAROLIMUS;

BIOLIMUS A9 ELUTING STENT; CLINICAL TRIAL; CORONARY ARTERY DISEASE; CORONARY STENT; DRUG ELUTING STENT; EVEROLIMUS ELUTING STENT; FOLLOW UP; HEART INFARCTION; HUMAN; PACLITAXEL ELUTING STENT; RESTENOSIS; REVASCULARIZATION; REVIEW; SIROLIMUS ELUTING STENT; STENT; STENT THROMBOSIS; SUSTAINED RELEASE PREPARATION; ZOTAROLIMUS ELUTING STENT;

ANGIOPLASTY, BALLOON, CORONARY; ANIMALS; CORONARY ARTERY DISEASE; CORONARY RESTENOSIS; DRUG-ELUTING STENTS; HUMANS; MYOCARDIAL INFARCTION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SIROLIMUS; THROMBOSIS;

EID: 77958113259     PISSN: 14779072     EISSN: 17448344     Source Type: Journal    
DOI: 10.1586/erc.10.127     Document Type: Review

References (80)

1. 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. 331, 496-501 (1994).
2. 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. 331, 489-495 (1994).
3. Grube E, Silber S, Hauptmann KE et al. Taxus I: six-and twelve-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions. Circulation 107, 38-42 (2003).
4. Morice MC, Serruys PW, Sousa JE et al. A randomized comparison of a sirolimuseluting stent with a standard stent for coronary revascularization. N. Engl. J. Med. 346, 1773-1780 (2002).
5. 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. 349, 1315-1323 (2003).
6. 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 109, 1942-1947 (2004).
7. Stone GW, Ellis SG, Cox DA et al. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N. Engl. J. Med. 350, 221-231 (2004).
8. Marroquin OC, Selzer F, Mulukutla SR et al. A comparison of bare-metal and drug-eluting stents for off-label indications. N. Engl. J. Med. 358, 342-352 (2008).
9. Win HK, Caldera AE, Maresh K et al. Clinical outcomes and stent thrombosis following off-label use of drug-eluting stents. JAMA 297, 2001-2009 (2007).
10. McFadden EP, Stabile E, Regar E et al. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy Lancet 364, 1519-1521 (2004).
11. Wenaweser P, Daemen J, Zwahlen M et al. Incidence and correlates of drug-eluting stent thrombosis in routine clinical practice. 4-year results from a large 2-institutional cohort study J. Am. Coll. Cardiol. 52, 1134-1140 (2008).
12. 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 369, 667-678 (2007).
13. Ozaki Y, Okumura M, Ismail TF et al. The fate of incomplete stent apposition with drug-eluting stents: an optical coherence tomography-based natural history study. Eur. Heart J. 31, 1470-1476 (2010).
14. Cook S, Ladich E, Nakazawa G et al. Correlation of intravascular ultrasound fndings with histopathological analysis of thrombus aspirates in patients with very late drug-eluting stent thrombosis. Circulation 120, 391-399 (2009).
15. Vezina C, Kudelski A, Sehgal SN. Rapamycin (AY-22,989), a new antifungal antibiotic. I. Taxonomy of the producing streptomycete and isolation of the active principle. J. Antibiot. (Tokyo) 28, 721-726 (1975).
16. Gallo R, Padurean A, Jayaraman T et al. Inhibition of intimal thickening after balloon angioplasty in porcine coronary arteries by targeting regulators of the cell cycle. Circulation 99, 2164-2170 (1999).
17. Marx SO, Jayaraman T, Go LO, Marks AR. Rapamycin-FKBP inhibits cell cycle regulators of proliferation in vascular smooth muscle cells. Circ. Res. 76, 412-417 (1995).
18. Roque M, Cordon-Cardo C, Fuster V, Reis ED, Drobnjak M, Badimon JJ. Modulation of apoptosis, proliferation, and p27 expression in a porcine coronary angioplasty model. Atherosclerosis 153, 315-322 (2000).
19. Schofer J, Schluter M, Gershlick AH et al. Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blind, randomised controlled trial (E-SIRIUS). Lancet 362, 1093-1099 (2003).
20. Schampaert E, Cohen EA, Schluter M et al. The Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries (C-SIRIUS). J. Am. Coll. Cardiol. 43, 1110-1115 (2004).
21. Caixeta A, Leon MB, Lansky AJ et al. 5-year clinical outcomes after sirolimus-eluting stent implantation insights from a patient-level pooled analysis of 4 randomized trials comparing sirolimus-eluting stents with bare-metal stents. J. Am. Coll. Cardiol. 54, 894-902 (2009).
22. Ikari Y, Kotani J, Kozuma K, Kyo E, Nakamura M, Yokoi H. Assessment of sirolimus-eluting coronary stent implantation with aspirin plus low dose ticlopidine administration: one year results from CYPHER Stent Japan Post-Marketing Surveillance Registry (J-PMS). Circ. J. 73, 1038-1044 (2009).
23. Kelbaek H, Klovgaard L, Helqvist S et al. Long-term outcome in patients treated with sirolimus-eluting stents in complex coronary artery lesions: 3-year results of the SCANDSTENT (Stenting Coronary Arteries in Non-Stress/Benestent Disease) trial. J. Am. Coll. Cardiol. 51, 2011-2016 (2008).
24. Urban P, Gershlick AH, Guagliumi G et al. Safety of coronary sirolimus-eluting stents in daily clinical practice: one-year follow-up of the e-Cypher registry Circulation 113, 1434-1441 (2006).
25. Zahn R, Hamm CW, Schneider S et al. Coronary stenting with the sirolimus-eluting stent in clinical practice: fnal results from the prospective multicenter German Cypher Stent Registry J. Interv. Cardiol. 23(1), 18-25 (2010).
26. Muldowney JA, III, Stringham JR, Levy SE et al. Antiproliferative agents alter vascular plasminogen activator inhibitor-1 expression: a potential prothrombotic mechanism of drug-eluting stents. Arterioscler. Thromb. Vasc. Biol. 27, 400-406 (2007).
27. Steffel J, Latini RA, Akhmedov A et al. Rapamycin, but not FK-506, increases endothelial tissue factor expression: implications for drug-eluting stent design. Circulation 112, 2002-2011 (2005).
28. Stahli BE, Camici GG, Steffel J et al. Paclitaxel enhances thrombin-induced endothelial tissue factor expression via c-Jun terminal NH2 kinase activation. Circ. Res. 99, 149-155 (2006).
29. Colombo A, Drzewiecki J, Banning A et al. Randomized study to assess the effectiveness of slow-and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions. Circulation 108, 788-794 (2003).
30. 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 294, 1215-1223 (2005).
31. Tanabe K, Serruys PW, Grube E et al. TAXUS III trial: in-stent restenosis treated with stent-based delivery of paclitaxel incorporated in a slow-release polymer formulation. Circulation 107, 559-564 (2003).
32. Ellis SG, Cannon LA, Mann T et al. Final 5-year outcomes from the TAXUS V de novo trial: long-term safety and effectiveness of the paclitaxel-eluting Taxus stent in complex lesions. Am. J. Cardiol. 104, 135D (2009).
33. Ellis SG, Stone GW, Cox DA et al. Long-term safety and effcacy with paclitaxel-eluting stents: 5-year fnal results of the TAXUS IV clinical trial (TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent). JACC Cardiovasc. Interv. 2, 1248-1259 (2009).
34. Turco MA, Ormiston JA, Popma JJ et al. Polymer-based, paclitaxel-eluting Taxus Liberté stent in de novo lesions: the pivotal TAXUS ATLAS trial. J. Am. Coll. Cardiol. 49, 1676-1683 (2007).
35. Turco MA, Ormiston JA, Popma JJ et al. Reduced risk of restenosis in small vessels and reduced risk of myocardial infarction in long lesions with the new thin-strut Taxus Liberté stent: 1-year results from the Taxus ATLAS program. JACC Cardiovasc. Interv. 1, 699-709 (2008).
36. Kereiakes DJ. Taxus PERSEUS workhorse. Presented at: ACC/I2 Scientifc Sessions 2010. Atlanta, GA, USA, 15 March 2010 (Abstract).
37. Hayward JA, Chapman D. Biomembrane surfaces as models for polymer design: the potential for haemocompatibility Biomaterials 5, 135-142 (1984).
38. Leon MB, Mauri L, Popma JJ et al. A randomized comparison of the ENDEAVOR zotarolimus-eluting stent versus the Taxus paclitaxel-eluting stent in de novo native coronary lesions 12-month outcomes from the ENDEAVOR IV trial. J. Am. Coll. Cardiol. 55, 543-554 (2010).
39. Kandzari DE, Leon MB, Popma JJ et al. Comparison of zotarolimus-eluting and sirolimus-eluting stents in patients with native coronary artery disease: a randomized controlled trial. J. Am. Coll. Cardiol. 48, 2440-2447 (2006).
40. Camenzind E, Wijns W, Mauri L et al. Rationale and design of the Patient Related Outcomes with Endeavor versus Cypher Stenting Trial (PROTECT): randomized controlled trial comparing the incidence of stent thrombosis and clinical events after sirolimus or zotarolimus drug-eluting stent implantation. Am. Heart J. 158, 902-909 (2009).
41. Grube E, Buellesfeld L. BioMatrix biolimus A9-eluting coronary stent: a next-generation drug-eluting stent for coronary artery disease. Expert Rev. Med. Devices 3, 731-741 (2006).
42. Costa RA, Lansky AJ, Abizaid A et al. Angiographic results of the frst human experience with the biolimus A9 drug-eluting stent for de novo coronary lesions. Am. J. Cardiol. 98, 443-446 (2006).
43. 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 372, 1163-1173 (2008).
44. Klauss V. LEADERS: a prospective, randomised, non-inferiority trial comparing biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer: 2-year clinical follow-up. Presented at: Transcatheter Cardiovascular Therapeutics 2009. San Francisco, CA, USA, 23 September 2010 (Abstract).
45. Schuler W, Sedrani R, Cottens S et al. SDZ RAD, a new rapamycin derivative: pharmacological properties in vitro and in vivo. Transplantation 64, 36-42 (1997).
46. Vitko S, Margreiter R, Weimar W et al. Three-year effcacy and safety results from a study of everolimus versus mycophenolate mofetil in de novo renal transplant patients. Am. J. Transplant. 5, 2521-2530 (2005).
47. Snell GI, Valentine VG, Vitulo P et al. Everolimus versus azathioprine in maintenance lung transplant recipients: an international, randomized, double-blind clinical trial. Am. J. Transplant. 6, 169-177 (2006).
48. Eisen HJ, Tuzcu EM, Dorent R et al. Everolimus for the prevention of allograft rejection and vasculopathy in cardiac-transplant recipients. N. Engl. J. Med. 349, 847-858 (2003).
49. Perkins EL, Boeke-Purkis BS, Wang Q, Stringer SK, Coleman LA. Xience V everolimus-eluting coronary stent system: a preclinical assessment. J. Interv. Cardiol. 22, S28-S40 (2009).
50. Ding N, Pacetti S, Tang F, Gada M, Roorda W. Xience V stent design and rational. J. Interv. Cardiol. 22, S18-S27 (2009).
51. Pache J, Kastrati A, Mehilli J et al. Intracoronary Stenting and Angiographic Results: Strut Thickness Effect on Restenosis Outcome (ISAR-STEREO-2) trial. J. Am. Coll. Cardiol. 41, 1283-1288 (2003).
52. Kastrati A, Mehilli J, Dirschinger J et al. Intracoronary Stenting and Angiographic Results: Strut Thickness Effect on Restenosis Outcome (ISAR-STEREO) trial. Circulation 103, 2816-2821 (2001).
53. Rittersma SZ, de Winter RJ, Koch KT et al. Impact of strut thickness on late luminal loss after coronary artery stent placement. Am. J. Cardiol. 93, 477-480 (2004).
54. Finn AV, Joner M, Nakazawa G et al. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation 115, 2435-2441 (2007).
55. Joner M, Finn AV, Farb A et al. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J. Am. Coll. Cardiol. 48, 193-202 (2006).
56. Joner M, Nakazawa G, Finn AV et al. Endothelial cell recovery between comparator polymer-based drug-eluting stents. J. Am. Coll. Cardiol. 52, 333-342 (2008).
57. Grube E, Sonoda S, Ikeno F et al. Six-and twelve-month results from frst human experience using everolimus-eluting stents with bioabsorbable polymer. Circulation 109, 2168-2171 (2004).
58. Tsuchiya Y, Lansky AJ, Costa RA et al. Effect of everolimus-eluting stents in different vessel sizes (from the pooled FUTURE I and II trials). Am. J. Cardiol. 98, 464-469 (2006).
59. 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 1, 58-65 (2005).
60. Tsuchida K, 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 1, 266-272 (2005).
61. Wiemer M, Serruys P, Miquel-Hebert K et al. Five-year long-term clinical follow-up of the Xience V everolimus eluting coronary stent system in the treatment of patients with de novo coronary artery lesions: the SPIRIT FIRST trial. Catheter. Cardiovasc. Interv. 75(7), 997-1003 (2010).
62. 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 2, 286-294 (2006).
63. Claessen BE, Beijk MA, Legrand V et al. Two-year clinical, angiographic, and intravascular ultrasound follow-up of the Xience V everolimus-eluting stent in the treatment of patients with de novo native coronary artery lesions: the SPIRIT II trial. Circ. Cardiovasc. Interv. 2, 339-347 (2009).
64. Garg S, Serruys P, Onuma Y et al. 3-year clinical follow-up of the Xience V everolimus-eluting coronary stent system in the treatment of patients with de novo coronary artery lesions: the SPIRIT II trial (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions). JACC Cardiovasc. Interv. 2, 1190-1198 (2009).
65. 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 299, 1903-1913 (2008).
66. Stone G. Three-year outcome of the SPIRIT III trial. Presented at: Transcatheter Cardiovascular Therapeutics (TCT). San Francisco, CA, USA, 21 September 2009.
67. Gordon PC, Applegate RJ, Hermiller JB et al. Clinical and angiographic outcomes with an everolimus-eluting stent in large coronary arteries: the SPIRIT III 4.0 mm registry. Catheter. Cardiovasc. Interv. 75, 179-186 (2010).
68. Stone GW, Rizvi A, Newman W et al. Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. N. Engl. J. Med. 362, 1663-1674 (2010).
69. Cutlip DE, Windecker S, Mehran R et al Clinical end points in coronary stent trials: a case for standardized defnitions. Circulation 115, 2344-2351 (2007).
70. Grube E. SPIRIT V diabetic randomised controlled trial: 1 year results. Presented at: EUROPCR 2010. Paris, France, 25 May 2010.
71. 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 375, 201-209 (2010).
72. Serruys PW. Twelve months primary endpoint results of the RESOLUTE all-comers trial: a randomised comparison of a zotarolimus-eluting stent with an everolimus-eluting stent for percutaneous coronary intervention. Presented at: EUROPCR 2010. Paris, France, 25 May 2010.
73. Byrne RA, Kastrati A, Kufner S et al. Randomized, non-inferiority trial of three limus agent-eluting stents with different polymer coatings: the Intracoronary Stenting and Angiographic Results: Test Effcacy of 3 Limus-Eluting Stents (ISAR-TEST-4) trial. Eur. Heart J. 30, 2441-2449 (2009).
74. Onuma Y, Kukreja N, Piazza N et al. The everolimus-eluting stent in real-world patients: 6-month follow-up of the X-SEARCH (Xience V Stent Evaluated at Rotterdam Cardiac Hospital) registry J. Am. Coll. Cardiol. 54, 269-276 (2009).
75. Latib A, Ferri L, Ielasi A et al. Clinical outcomes after unrestricted implantation of everolimus-eluting stents. JACC Cardiovasc. Interv. 2, 1219-1226 (2009).
76. Grube E. SPIRIT V registry: one-year follow-up. Presented at: EUROPCR 2009. Barcelona, Spain, 21 May 2009.
77. Serruys PW, Morice MC, Kappetein AP et al. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N. Engl. J. Med. 360, 961-972 (2009).
78. Claessen BE, Stone GW, Smits PC et al. Would SYNTAX have been a positive trial if Xience V was used in stead of TAXUS? A meta-analysis of a frst-generation vs. a second generation drug eluting stent system. Neth. Heart. J. 18, 451-453 (2010).
79. Ormiston JA, Serruys PW, Regar E et al. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet 371, 899-907 (2008).
80. Serruys PW, Ormiston JA, Onuma Y et al. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet 373, 897-910 (2009).