Xience V™ everolimus-eluting coronary stent

Expert Review of Medical Devices

Volumn 6, Issue 3, 2009, Pages 219-229

  Kukreja, Neville ^a   Onuma, Yoshinobu ^a   Serruys, Patrick W ^a  

^a ERASMUS MEDICAL CENTER   (Netherlands)

Author keywords

Cobalt chromium; Drug eluting stent; Everolimus; Percutaneous coronary intervention; Xience V

Indexed keywords

EVEROLIMUS; PACLITAXEL; POLYMER; RAPAMYCIN; BIOMATERIAL; CHROMIUM DERIVATIVE; DRUG DERIVATIVE; IMMUNOSUPPRESSIVE AGENT;

ARTERY OCCLUSION; ARTICLE; BIOCOMPATIBILITY; CORONARY ARTERY DISEASE; CORONARY STENT; DRUG ELUTING STENT; DRUG MECHANISM; DRUG STRUCTURE; HEART INFARCTION; HUMAN; IN-STENT RESTENOSIS; MORTALITY; NONHUMAN; PATIENT SAFETY; ST SEGMENT ELEVATION; GRAFT OCCLUSION; RANDOMIZED CONTROLLED TRIAL; REVIEW;

TAXUS;

CHROMIUM ALLOYS; COATED MATERIALS, BIOCOMPATIBLE; CORONARY ARTERY DISEASE; DRUG-ELUTING STENTS; GRAFT OCCLUSION, VASCULAR; HUMANS; IMMUNOSUPPRESSIVE AGENTS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SIROLIMUS;

EID: 67651012783     PISSN: 17434440     EISSN: 17452422     Source Type: Journal    
DOI: 10.1586/erd.09.1     Document Type: Article

References (78)

1. Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N. Engl. J. Med. 316(12), 701-706 (1987).
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. N. Engl. J. Med. 331(8), 489-495 (1994).
3. 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. N. Engl. J. Med. 331(8), 496-501 (1994).
4. Halloran PF. Immunosuppressive drugs for kidney transplantation. N. Engl. J. Med. 351(26), 2715-2729 (2004).
5. Burke SE, Lubbers NL, Chen YW et al. Neointimal formation after balloon-induced vascular injury in Yucatan minipigs is reduced by oral rapamycin. J. Cardiovasc. Pharmacol. 33(6), 829-835 (1999).
6. 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(16), 2164-2170 (1999).
7. Marx SO, Marks AR. Bench to bedside: the development of rapamycin and its application to stent restenosis. Circulation 104(8), 852-855 (2001).
8. Morice M-C, 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. 346(23), 1773-1780 (2002).
9. 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(14), 1315-1323 (2003).
10. Serruys PW, Ong ATL, Morice M-C et al. Arterial revascularisation therapies study part ii - sirolimus-eluting stents for the treatment of patients with multivessel de novo coronary artery lesions. Euro Intervention 1(2), 147-156 (2005).
11. Daemen J, Ong AT, Stefanini GG et al. Three-year clinical follow-up of the unrestricted use of sirolimus-eluting stents as part of the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) registry. Am. J. Cardiol. 98(7), 895-901 (2006).
12. 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(9390), 1093-1099 (2003).
13. 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(6), 1110-1115 (2004).
14. 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 109(11), 1366-1370 (2004).
15. 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(11), 1434-1441 (2006).
16. Kastrati A, Mehilli J, Pache J et al. Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents. N. Engl. J. Med. 356(10), 1030-1039 (2007).
17. Spaulding C, Daemen J, Boersma E, Cutlip DE, Serruys PW. A pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents. N. Engl. J. Med. 356(10), 989-997 (2007).
18. Spaulding C, Henry P, Teiger E et al. Sirolimus-eluting versus uncoated stents in acute myocardial infarction. N. Engl. J. Med. 355(11), 1093-1104 (2006).
19. Stettler C, Wandel S, Allemann S et al. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-ana lysis. Lancet 370(9591), 937-948 (2007).
20. 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(13), 2002-2011 (2005).
21. Imanishi T, Kobayashi K, Kuki S, Takahashi C, Akasaka T. Sirolimus accelerates senescence of endothelial progenitor cells through telomerase inactivation. Atherosclerosis 189(2), 288-296 (2006).
22. Muldowney JA 3rd, 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(2), 400-406 (2007).
23. Togni M, Windecker S, Cocchia R et al. Sirolimus-eluting stents associated with paradoxic coronary vasoconstriction. J. Am. Coll. Cardiol. 46(2), 231-236 (2005).
24. Hofma SH, van der Giessen WJ, van Dalen BM et al. Indication of long-term endothelial dysfunction after sirolimus-eluting stent implantation. Eur. Heart J. 27(2), 166-170 (2006).
25. Obata JE, Kitta Y, Takano H et al. Sirolimus-eluting stent implantation aggravates endothelial vasomotor dysfunction in the infarct-related coronary artery in patients with acute myocardial infarction. J. Am. Coll. Cardiol. 50(14), 1305-1309 (2007).
26. Fuke S, Maekawa K, Kawamoto K et al. Impaired endothelial vasomotor function after sirolimus-eluting stent implantation. Circ. J. 71(2), 220-225 (2007).
27. 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(3), 221-231 (2004).
28. 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(10), 1215-1223 (2005).
29. Ong ATL, Serruys PW, Aoki J et al. The unrestricted use of paclitaxel- versus sirolimus-eluting stents for coronary artery disease in an unselected population: one-year results of the Taxus-Stent Evaluated at Rotterdam Cardiology Hospital (T-SEARCH) registry. J. Am. Coll. Cardiol. 45(7), 1135-1141 (2005).
30. Grube E, Dawkins KD, Guagliumi G et al. TAXUS VI 2-year follow-up: randomized comparison of polymer-based paclitaxel-eluting with bare metal stents for treatment of long, complex lesions. Eur. Heart J. 28(21), 2578-2582 (2007).
31. Daemen J, Spaulding C, Jacob S, Boersma E, Varenne O, Serruys P. A pooled safety ana lysis of data comparing paclitaxel-eluting stents with bare-metal stents. EuroIntervention 3, 392-399 (2007).
32. Laarman GJ, Suttorp MJ, Dirksen MT et al. Paclitaxel-eluting versus uncoated stents in primary percutaneous coronary intervention. N. Engl. J. Med. 355(11), 1105-1113 (2006).
33. 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(7), 788-794 (2003).
34. 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(2), 149-155 (2006).
35. Togni M, Raber L, Cocchia R et al. Local vascular dysfunction after coronary paclitaxel-eluting stent implantation. Int. J. Cardiol. 120(2), 212-220 (2007).
36. 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(9562), 667-678 (2007).
37. Iakovou I, Schmidt T, Bonizzoni E et al. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA 293(17), 2126-2130 (2005).
38. 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 113(8), 1108-1113 (2006).
39. Park D-W, Park S-W, Park K-H et al. Frequency of and risk factors for stent thrombosis after drug-eluting stent implantation during long-term follow-up. Am. J. Cardiol. 98(3), 352-356 (2006).
40. 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(1), 193-202 (2006).
41. 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 94(7), 1690-1697 (1996).
42. 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 109(6), 701-705 (2004).
43. 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. 47(1), 175-181 (2006).
44. 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. 51(2), 172-209 (2008).
45. Aoki J, Nakazawa G, Tanabe K et al. Incidence and clinical impact of coronary stent fracture after sirolimus-eluting stent implantation. Catheter Cardiovasc. Interv. 69(3), 380-386 (2007).
46. Kastrati A, Mehilli J, Dirschinger J et al. Intracoronary Stenting and Angiographic Results: Strut Thickness Effect on Restenosis Outcome (ISAR-STEREO) trial. Circulation 103(23), 2816-2821 (2001).
47. Kereiakes DJ, Cox DA, Hermiller JB et al. Usefulness of a cobalt chromium coronary stent alloy. Am. J. Cardiol. 92(4), 463-466 (2003).
48. 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(8), 1283-1288 (2003).
49. Schuler W, Sedrani R, Cottens S et al. SDZ RAD, a new rapamycin derivative: pharmacological properties in vitro and in vivo. Transplantation 64(1), 36-42 (1997).
50. 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(9), 847-858 (2003).
51. Verheye S, Martinet W, Kockx MM et al. Selective clearance of macrophages in atherosclerotic plaques by autophagy. J. Am. Coll. Cardiol. 49(6), 706-715 (2007).
52. Farb A, John M, Acampado E, Kolodgie FD, Prescott MF, Virmani R. Oral everolimus inhibits in-stent neointimal growth. Circulation 106(18), 2379-2384 (2002).
53. Carter AJ, Brodeur A, Collingwood R et al. Experimental efficacy of an everolimus eluting cobalt chromium stent. Catheter Cardiovasc. Interv., 68(1), 97-103 (2006).
54. Joner M, Nakazawa G, Finn AV et al. Endothelial cell recovery between comparator polymer-based drug-eluting stents. J. Am. Coll. Cardiol. 52(5), 333-342 (2008).
55. 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 109(18), 2168-2171 (2004).
56. 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. 95(1), 113-116 (2005).
57. 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(4), 464-469 (2006).
58. Serruys PW, Ong ATL, Piek JJ et al. A randomized comparison of a durable polymer Everolimus-eluting stent with bare metal coronary stent: the SPIRIT first trial. EuroIntervention 1(1), 58-65 (2005).
59. Tsuchida K, Piek JJ, Neumann F 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).
60. Beijk MA, Neumann F, Wiemer M et al. Two-year results of a durable polymer everolimus-eluting stent in de novo coronary artery stenosis (the SPIRIT FIRST trial). EuroIntervention 3, 206-212 (2007).
61. Cutlip DE, Windecker S, Mehran R et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 115(17), 2344-2351 (2007).
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. Khattab A, Richardt G, Verin V et al. Differentiated ana lysis of an everolimus-eluting stent and a paclitaxel-eluting stent among higher risk subgroups for restenosis: results from the SPIRIT II trial. EuroIntervention 3, 566-573 (2008).
64. PW Serruys. SPIRIT II trial 24 month data. Presented at: The American College of Cardiology 57th Annual Scientific Session. Chicago, IL, USA. 29 March- 1 April 2008.
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(16), 1903-1913 (2008).
66. Grube E. The 30-day results of the SPIRIT V trial. Presented at: European Society of Cardiology Congress. Munich, Germany, 30 August-3 September 2008.
67. Serruys, PW, Kukreja, N, Onuma, Y, van Domburg, R. Unrestricted use of Everolimus-eluting stents: 30-day clinical outcome of the Xience V Stent Evaluated At Rotterdam Cardiology Hospital (X-SEARCH) registry. Presented at: The American College of Cardiology 57th Annual Scientific Session. Chicago, IL, USA. 29 March-1 April 2008.
68. Lemos PA, Serruys PW, van Domburg RT et al. Unrestricted utilization of sirolimus-eluting stents compared with conventional bare stent implantation in the 'real world': the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiolog Hospital (RESEARCH) registry. Circulation 109(2), 190-195 (2004).
69. 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. 100(8 Suppl. 2), S56-S61 (2007).
70. Fajadet J, Wijns W, Laarman G-J et al. Randomized, double-blind, 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 114(8), 798-806 (2006).
71. 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(12), 2440-2447 (2006).
72. Byrne R. A polymer-free dual drug-eluting stent in patients with coronary artery disease: randomized trial versus polymer-based DES: ISAR-TEST 2 trial. Eur. Heart J. DOI:10.1093/eurheartj/ehp044 (2009) (Epub ahead of print).
73. Lassen JF, Rasmussen K, Galløe A et al. SORT-OUT III: a prospective randomized comparison of zotarolimus-eluting and sirolimus-eluting stents in patients with coronary artery disease. Proceedings of the 20th Transcatheter Cardiovascular Therapeutics Symposium. DC, USA, 12-17 October 2008.
74. Meredith I, Worthley S, Whitbourn R et al. The next-generation Endeavor™ Resolute™ stent: 4-month clinical and angiographic results from the Resolute first-in-man trial. EuroIntervention 3, 50-53 (2007).
75. Grube E, Hauptmann K-E, 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 1(1), 53-57 (2005).
76. Costa RA, Lansky AJ, Abizaid A et al. Angiographic results of the first human experience with the biolimus A9 drug-eluting stent for de novo coronary lesions. Am. J. Cardiol. 98(4), 443-446 (2006).
77. 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(9644), 1163-1173 (2008).
78. 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(9616), 899-907 (2008).