Drug-Eluting Stent Safety

American Journal of Cardiology

Volumn 100, Issue 8 SUPPL. 2, 2007, Pages

  Slottow, Tina L Pinto ^a   Waksman, Ron ^a  

^a WASHINGTON HOSPITAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLCHOLINE; GLYCERYL TRINITRATE;

ANGIOCARDIOGRAPHY; ARTICLE; BIOSAFETY; CELL FUNCTION; CORONARY ARTERY DISEASE; DRUG ELUTING STENT; ENDOTHELIAL DYSFUNCTION; FOLLOW UP; HEART INFARCTION; INTRAVASCULAR ULTRASOUND; OUTCOME ASSESSMENT; PATHOPHYSIOLOGY; PERCUTANEOUS CORONARY INTERVENTION; PRIORITY JOURNAL; RESTENOSIS; RISK ASSESSMENT; THROMBOSIS; VASCULAR ENDOTHELIUM;

ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY; CORONARY DISEASE; CORONARY RESTENOSIS; CORONARY THROMBOSIS; DRUG-ELUTING STENTS; HUMANS; SAFETY;

EID: 35348937713     PISSN: 00029149     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.amjcard.2007.08.017     Document Type: Article

References (60)

1. Leon M.B., Baim D.S., Popma J.J., Gordon P.C., Cutlip D.E., Ho K.K., Giambartolomei A., Diver D.J., Lasorda D.M., Williams D.O., Pocock S.J., Kuntz R.E., and Stent Anticoagulation Restenosis Study Investigators. A clinical trial comparing three antithrombotic-drug regimens after coronary-artery stenting. N Engl J Med 339 (1998) 1665-1671
2. Fischman D.L., Leon M.B., Baim D.S., Schatz R.A., Savage M.P., Penn I., Detre K., Veltri L., Ricci D., Nobuyoshi M., et al., Stent Restenosis Study Investigators. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. N Engl J Med 331 (1994) 496-501
3. Serruys P.W., de Jaegere P., Kiemeneij F., Macaya C., Rutsch W., Heyndrickx G., Emanuelsson H., Marco J., Legrand V., Materne P., et al., Benestent Study Group. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. N Engl J Med 331 (1994) 489-495
4. Sigwart U., Puel J., Mirkovitch V., Joffre F., and Kappenberger L. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med 316 (1987) 701-706
5. Serruys P.W., Unger F., Sousa J.E., Jatene A., Bonnier H.J., Schonberger J.P., Buller N., Bonser R., van den Brand M.J., van Herwerden L.A., Morel M.A., and van Hout B.A. Comparison of coronary-artery bypass surgery and stenting for the treatment of multivessel disease. N Engl J Med 344 (2001) 1117-1124
6. Haude M., Erbel R., Issa H., Straub U., Rupprecht H.J., Treese N., and Meyer J. Subacute thrombotic complications after intracoronary implantation of Palmaz-Schatz stents. Am Heart J 126 (1993) 15-22
7. Colombo A., Hall P., Nakamura S., Almagor Y., Maiello L., Martini G., Gaglione A., Goldberg S.L., and Tobis J.M. Intracoronary stenting without anticoagulation accomplished with intravascular ultrasound guidance. Circulation 91 (1995) 1676-1688
8. Tolleson T.R., Newby L.K., Harrington R.A., Bhapkar M.V., Verheugt F.W., Berger P.B., Moliterno D.J., White H.D., Ohman E.M., Van de Werf F., Topol E.J., and Califf R.M. Frequency of stent thrombosis after acute coronary syndromes (from the SYMPHONY and 2nd SYMPHONY trials). Am J Cardiol 92 (2003) 330-333
9. Kastrati A., Schomig A., Elezi S., Schuhlen H., Dirschinger J., Hadamitzky M., Wehinger A., Hausleiter J., Walter H., and Neumann F.J. Predictive factors of restenosis after coronary stent placement. J Am Coll Cardiol 30 (1997) 1428-1436
10. Cutlip D.E., Chhabra A.G., Baim D.S., Chauhan M.S., Marulkar S., Massaro J., Bakhai A., Cohen D.J., Kuntz R.E., and Ho K.K. Beyond restenosis: five-year clinical outcomes from second-generation coronary stent trials. Circulation 110 (2004) 1226-1230
11. Morice M.C., Serruys P.W., Sousa J.E., Fajadet J., Ban Hayashi E., Perin M., Colombo A., Schuler G., Barragan P., Guagliumi G., Molnar F., and Falotico R. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 346 (2002) 1773-1780
12. Ardissino D., Cavallini C., Bramucci E., Indolfi C., Marzocchi A., Manari A., Angeloni G., Carosio G., Bonizzoni E., Colusso S., Repetto M., and Merlini P.A. Sirolimus-eluting vs uncoated stents for prevention of restenosis in small coronary arteries: a randomized trial. JAMA 292 (2004) 2727-2734
13. Hill R.A., Dundar Y., Bakhai A., Dickson R., and Walley T. Drug-eluting stents: an early systematic review to inform policy. Eur Heart J 25 (2004) 902-919
14. © sirolimus-eluting coronary stent (2006). http://www.cordis.com/active/crdus/en_US/html/cordis/downloads/press/ 155_5130_1_FDA_Panel_PR.pdf December 7. Available at: http://www.cordis.com/active/crdus/en_US/html/cordis/downloads/press/ 155_5130_1_FDA_Panel_PR.pdf. Accessed May 8, 2007.
15. ™ coronary stent system (2005). http://bostonscientific.mediaroom.com/index.php?s=43&item=451 January 19. Available at: http://bostonscientific.mediaroom.com/index.php?s=43&item=451. Accessed December 12, 2006.
16. Farb A. FDA summary: pathology and clinical overview (2006) Presented at: Meeting of the US Food and Drug Administration Circulatory System Devices Panel; Gaithersburg, MD; December 7-8.
17. Moses J.W., Leon M.B., Popma J.J., Fitzgerald P.J., Holmes D.R., O'Shaughnessy C., Caputo R.P., Kereiakes D.J., Williams D.O., Teirstein P.S., Jaeger J.L., and Kuntz R.E. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 349 (2003) 1315-1323
18. Weisz G., Leon M.B., Holmes Jr. D.R., Kereiakes D.J., Clark M.R., Cohen B.M., Ellis S.G., Coleman P., Hill C., Shi C., et al. Two-year outcomes after sirolimus-eluting stent implantation: results from the Sirolimus-Eluting Stent in de Novo Native Coronary Lesions (SIRIUS) trial. J Am Coll Cardiol 47 (2006) 1350-1355
19. ™ sirolimus-eluting coronary stents: three-year follow-up of the SIRIUS Study (2005) Presented at: American College of Cardiology Scientific Sessions; Orlando, FL; March 6-9.
20. Leon M.B. An evidence-based medicine appraisal of clinical indications for drug-eluting stents-appropriate use, abuse, and uncertainties (2006) Presented at: Transcatheter Therapeutics; Washington, DC; October.
21. Stone G.W., Ellis S.G., Cox D.A., Hermiller J., O'Shaughnessy C., Mann J.T., Turco M., Caputo R., Bergin P., Greenberg J., Popma J.J., and Russell M.E. One-year clinical results with the slow-release, polymer-based, paclitaxel-eluting TAXUS stent: the TAXUS-IV trial. Circulation 109 (2004) 1942-1947
22. Stone G.W. 3-year clinical results of the TAXUS-IV trial (2005) Presented at: Transcatheter Therapeutics; Washington, DC; October.
23. Kimura T., Yokoi H., Nakagawa Y., Tamura T., Kaburagi S., Sawada Y., Sato Y., Hamasaki N., Nosaka H., and Nobuyoshi M. Three-year follow-up after implantation of metallic coronary-artery stents. N Engl J Med 334 (1996) 561-566
24. Kimura T., Abe K., Shizuta S., Odashiro K., Yoshida Y., Sakai K., Kaitani K., Inoue K., Nakagawa Y., Yokoi H., et al. Long-term clinical and angiographic follow-up after coronary stent placement in native coronary arteries. Circulation 105 (2002) 2986-2991
25. Serry R., and Penny W.F. Endothelial dysfunction after sirolimus-eluting stent placement. J Am Coll Cardiol 46 (2005) 237-238
26. Togni M., Windecker S., Cocchia R., Wenaweser P., Cook S., Billinger M., Meier B., and Hess O.M. Sirolimus-eluting stents associated with paradoxic coronary vasoconstriction. J Am Coll Cardiol 46 (2005) 231-236
27. Hofma S.H., van der Giessen W.J., van Dalen B.M., Lemos P.A., McFadden E.P., Sianos G., Ligthart J.M., van Essen D., de Feyter P.J., and Serruys P.W. Indication of long-term endothelial dysfunction after sirolimus-eluting stent implantation. Eur Heart J 27 (2006) 166-170
28. Lerman A., and Eeckhout E. Coronary endothelial dysfunction following sirolimus-eluting stent placement: should we worry about it?. Eur Heart J 27 (2006) 125-126
29. Nakamura M., Kataoka T., Honda Y., Bonneau H.N., Hibi K., Kitamura K., Tamai H., Aizawa T., Yock P.G., and Fitzgerald P.J. Late incomplete stent apposition and focal vessel expansion after bare metal stenting. Am J Cardiol 92 (2003) 1217-1219
30. Mintz G.S. What to do about late incomplete stent apposition?. Circulation 115 (2007) 2379-2381
31. Shah V.M., Mintz G.S., Apple S., and Weissman N.J. Background incidence of late malapposition after bare-metal stent implantation. Circulation 106 (2002) 1753-1755
32. Hong M.K., Mintz G.S., Lee C.W., Kim Y.H., Lee S.W., Song J.M., Han K.H., Kang D.H., Song J.K., Kim J.J., Park S.W., and Park S.J. Incidence, mechanism, predictors, and long-term prognosis of late stent malapposition after bare-metal stent implantation. Circulation 109 (2004) 881-886
33. Tanabe K., Serruys P.W., Degertekin M., Grube E., Guagliumi G., Urbaszek W., Bonnier J., Lablanche J.M., Siminiak T., Nordrehaug J., et al. Incomplete stent apposition after implantation of paclitaxel-eluting stents or bare metal stents: insights from the randomized TAXUS II trial. Circulation 111 (2005) 900-905
34. Hong M.K., Mintz G.S., Lee C.W., Park D.W., Park K.M., Lee B.K., Kim Y.H., Song J.M., Han K.H., Kang D.H., et al. Late stent malapposition after drug-eluting stent implantation: an intravascular ultrasound analysis with long-term follow-up. Circulation 113 (2006) 414-419
35. Kimura M., Mintz G.S., Carlier S., Takebayashi H., Fujii K., Sano K., Yasuda T., Costa R.A., Costa Jr. J.R., Quen J., et al. Outcome after acute incomplete sirolimus-eluting stent apposition as assessed by serial intravascular ultrasound. Am J Cardiol 98 (2006) 436-442
36. Ako J., Morino Y., Honda Y., Hassan A., Sonoda S., Yock P.G., Leon M.B., Moses J.W., Bonneau H.N., and Fitzgerald P.J. Late incomplete stent apposition after sirolimus-eluting stent implantation: a serial intravascular ultrasound analysis. J Am Coll Cardiol 46 (2005) 1002-1005
37. Degertekin M., Serruys P.W., Tanabe K., Lee C.H., Sousa J.E., Colombo A., Morice M.C., Ligthart J.M., and de Feyter P.J. Long-term follow-up of incomplete stent apposition in patients who received sirolimus-eluting stent for de novo coronary lesions: an intravascular ultrasound analysis. Circulation 108 (2003) 2747-2750
38. Cook S., Wenaweser P., Togni M., Billinger M., Morger C., Seiler C., Vogel R., Hess O., Meier B., and Windecker S. Incomplete stent apposition and very late stent thrombosis after drug-eluting stent implantation. Circulation 115 (2007) 2426-2434
39. Siqueira D.A., Abizaid A.A., Costa J.D., Feres F., Mattos L.A., Staico R., Tanajura L.F., Chaves A., Centemero M., Sousa A.G., and Sousa J.E. Late incomplete apposition after drug-eluting stent implantation: incidence and potential for adverse clinical outcomes. Eur Heart J 11 (2007) 1304-1309
40. Cutlip D.E., Baim D.S., Ho K.K., Popma J.J., Lansky A.J., Cohen D.J., Carrozza Jr. J.P., Chauhan M.S., Rodriguez O., and Kuntz R.E. Stent thrombosis in the modern era: a pooled analysis of multicenter coronary stent clinical trials. Circulation 103 (2001) 1967-1971
41. Iakovou I., Schmidt T., Bonizzoni E., Ge L., Sangiorgi G.M., Stankovic G., Airoldi F., Chieffo A., Montorfano M., Carlino M., et al. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA 293 (2005) 2126-2130
42. Ong A.T., Hoye A., Aoki J., van Mieghem C.A., Rodriguez Granillo G.A., Sonnenschein K., Regar E., McFadden E.P., Sianos G., van der Giessen W.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 45 (2005) 947-953
43. Cutlip D.E., Windecker S., Mehran R., Boam A., Cohen D.J., van Es G.A., Steg P.G., Morel M.A., Mauri L., Vranckx P., et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 115 (2007) 2344-2351
44. Honda Y., and Fitzgerald P.J. Stent thrombosis: an issue revisited in a changing world. Circulation 108 (2003) 2-5
45. Luscher T.F., Steffel J., Eberli F.R., Joner M., Nakazawa G., Tanner F.C., and Virmani R. Drug-eluting stent and coronary thrombosis: biological mechanisms and clinical implications. Circulation 115 (2007) 1051-1058
46. Schwartz R.S., Chronos N.A., and Virmani R. Preclinical restenosis models and drug-eluting stents: still important, still much to learn. J Am Coll Cardiol 44 (2004) 1373-1385
47. Virmani R., Guagliumi G., Farb A., Musumeci G., Grieco N., Motta T., Mihalcsik L., Tespili M., Valsecchi O., and Kolodgie F.D. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious?. Circulation 109 (2004) 701-705
48. Nebeker J.R., Virmani R., Bennett C.L., Hoffman J.M., Samore M.H., Alvarez J., Davidson C.J., McKoy J.M., Raisch D.W., Whisenant B.K., 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 (2006) 175-181
49. Joner M., Finn A.V., Farb A., Mont E.K., Kolodgie F.D., Ladich E., Kutys R., Skorija K., Gold H.K., and Virmani R. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol 48 (2006) 193-202
50. Farb A., Burke A.P., Kolodgie F.D., and Virmani R. Pathological mechanisms of fatal late coronary stent thrombosis in humans. Circulation 108 (2003) 1701-1706
51. Kotani J., Awata M., Nanto S., Uematsu M., Oshima F., Minamiguchi H., Mintz G.S., and Nagata S. Incomplete neointimal coverage of sirolimus-eluting stents: angioscopic findings. J Am Coll Cardiol 47 (2006) 2108-2111
52. Takano M., Ohba T., Inami S., Seimiya K., Sakai S., and Mizuno K. Angioscopic differences in neointimal coverage and in persistence of thrombus between sirolimus-eluting stents and bare metal stents after a 6-month implantation. Eur Heart J 27 (2006) 2189-2195
53. Guagliumi G., Farb A., Musumeci G., Valsecchi O., Tespili M., Motta T., and Virmani R. Images in cardiovascular medicine. Sirolimus-eluting stent implanted in human coronary artery for 16 months: pathological findings. Circulation 107 (2003) 1340-1341
54. Finn A.V., Joner M., Nakazawa G., Kolodgie F., Newell J., John M.C., Gold H.K., and Virmani R. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation 115 (2007) 2435-2441
55. Cheneau E., Leborgne L., Mintz G.S., Kotani J., Pichard A.D., Satler L.F., Canos D., Castagna M., Weissman N.J., and Waksman R. Predictors of subacute stent thrombosis: results of a systematic intravascular ultrasound study. Circulation 108 (2003) 43-47
56. Moreno R., Fernandez C., Hernandez R., Alfonso F., Angiolillo D.J., Sabate M., Escaned J., Banuelos C., Fernandez-Ortiz A., and Macaya C. Drug-eluting stent thrombosis: results from a pooled analysis including 10 randomized studies. J Am Coll Cardiol 45 (2005) 954-959
57. Kuchulakanti P.K., Chu W.W., Torguson R., Ohlmann P., Rha S.W., Clavijo L.C., Kim S.W., Bui A., Gevorkian N., Xue Z., et al. Correlates and long-term outcomes of angiographically proven stent thrombosis with sirolimus- and paclitaxel-eluting stents. Circulation 113 (2006) 1108-1113
58. Park D.W., Park S.W., Park K.H., Lee B.K., Kim Y.H., Lee C.W., Hong M.K., Kim J.J., and Park S.J. Frequency of and risk factors for stent thrombosis after drug-eluting stent implantation during long-term follow-up. Am J Cardiol 98 (2006) 352-356
59. Wenaweser P., Rey C., Eberli F.R., Togni M., Tuller D., Locher S., Remondino A., Seiler C., Hess O.M., Meier B., and Windecker S. Stent thrombosis following bare-metal stent implantation: success of emergency percutaneous coronary intervention and predictors of adverse outcome. Eur Heart J 26 (2005) 1180-1187
60. Fajadet J., Wijns W., Laarman G.J., Kuck K.H., Ormiston J., Munzel T., Popma J.J., Fitzgerald P.J., Bonan R., and Kuntz R.E. 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 (2006) 798-806