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

European Heart Journal

Volumn 32, Issue 19, 2011, Pages 2454-2463

  Gutiérrez Chico, Juan Luis ^a   Van Geuns, Robert Jan ^a   Regar, Evelyn ^a   Van Der Giessen, Willem J ^a   Kelbæk, Henning ^b   Saunamäki, Kari ^b   Escaned, Javier ^c   Gonzalo, Nieves ^c   Di Mario, Carlo ^d   Borgia, Francesco ^d   Nüesch, Eveline ^e   García García, Hctor M ^f   Silber, Sigmund ^g   Windecker, Stephan ^h   Serruys, Patrick W ^a  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b International Center for Research and Research Training in Endocrine Disruption of Male Reproduction and Child Health   (Denmark)

^c HOSPITAL CLÍNICO SAN CARLOS   (Spain)

^d ROYAL BROMPTON HOSPITAL   (United Kingdom)

^e UNIVERSITY OF BERN   (Switzerland)

^f CARDIALYSIS   (Netherlands)

^g Kardiologische Gemeinschaftspraxis und Praxisklinik   (Germany)

^h Schweizerisches HerzzentrumInselspital   (Switzerland)

Author keywords

Angioplasty, transluminal, percutaneous coronary; Coronary vessels; Drug eluting stents; Everolimus; optical coherence; Poly(vinylidene fluoride co hexafluoropropylene); Polymers; Tomography; Zotarolimus

Indexed keywords

EVEROLIMUS; FLUOROPOLYMER; POLYMER; UNCLASSIFIED DRUG; ZOTAROLIMUS;

ADULT; ARTICLE; BIOCOMPATIBILITY; CONTROLLED STUDY; DRUG ELUTING STENT; FEMALE; FOLLOW UP; HUMAN; MAJOR CLINICAL STUDY; MALE; MATERIAL COATING; MULTICENTER STUDY; NEOINTIMA; OPTICAL COHERENCE TOMOGRAPHY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT DURATION;

AGED; CORONARY STENOSIS; DRUG-ELUTING STENTS; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MIDDLE AGED; POLYMERS; PROSPECTIVE STUDIES; SIROLIMUS; TOMOGRAPHY, OPTICAL COHERENCE; TREATMENT OUTCOME; TUBULIN MODULATORS;

EID: 80054071576     PISSN: 0195668X     EISSN: 15229645     Source Type: Journal    
DOI: 10.1093/eurheartj/ehr182     Document Type: Article

References (41)

1. Garg S, Serruys PW. Coronary stents: current status. J Am Coll Cardiol 2010;56: S1-S42.
2. Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G, Airoldi F, Chieffo A, Montorfano M, Carlino M, Michev I, Corvaja N, Briguori C, Gerckens U, Grube E, Colombo A. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA 2005;293: 2126-2130. (Pubitemid 40617065)
3. Ong AT, McFadden EP, Regar E, de Jaegere PP, van Domburg RT, Serruys PW. Late angiographic stent thrombosis (LAST) events with drug-eluting stents. J Am Coll Cardiol 2005;45:2088-2092. (Pubitemid 40814135)
4. Pfisterer M, Brunner-La Rocca HP, Buser PT, Rickenbacher P, Hunziker P, Mueller C, Jeger R, Bader F, Osswald S, Kaiser C. 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. (Pubitemid 44881238)
5. Lagerqvist B, James SK, Stenestrand U, Lindback J, Nilsson T, Wallentin L, the SCAAR Study Group. Long-term outcomes with drug-eluting stents versus baremetal stents in Sweden. N Engl J Med 2007;356:1009-1019. (Pubitemid 46376801)
6. Farb A, Heller PF, Shroff S, Cheng L, Kolodgie FD, Carter AJ, Scott DS, Froehlich J, Virmani R. Pathological analysis of local delivery of paclitaxel via a polymer-coated stent. Circulation 2001;104:473-479. (Pubitemid 32678280)
7. Farb AM, Burke APM, Kolodgie FDP, Virmani RM. Pathological mechanisms of fatal late coronary stent thrombosis in humans. Circulation 2003;108:1701-1706.
8. Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol 2006;48:193-202. (Pubitemid 43929240)
9. Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, Gold HK, Virmani R. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation 2007;115:2435-2441. (Pubitemid 46717966)
10. Virmani R, Guagliumi G, Farb A, Musumeci G, Grieco N, Motta T, Mihalcsik L, Tespili M, Valsecchi O, Kolodgie FD. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation 2004;109:701-705. (Pubitemid 38222887)
11. Duckers HJ, Soullie T, den Heijer P, Rensing B, de Winter RJ, Rau M, Mudra H, Silber S, Benit E, Verheye S, Wijns W, Serruys PW. Accelerated vascular repair following percutaneous coronary intervention by capture of endothelial progenitor cells promotes regression of neointimal growth at long term follow-up: final results of the Healing II trial using an endothelial progenitor cell capturing stent (Genous R stent). EuroIntervention 2007;3:350-358.
12. Suzuki Y, Ikeno F, Koizumi T, Tio F, Yeung AC, Yock PG, Fitzgerald PJ, Fearon WF. In vivo comparison between optical coherence tomography and intravascular ultrasound for detecting small degrees of in-stent neointima after stent implantation. JACC Cardiovasc Interv 2008;1:168-173. (Pubitemid 351506553)
13. Prati F, Zimarino M, Stabile E, Pizzicannella G, Fouad T, Rabozzi R, Filippini A, Pizzicannella J, Cera M, De Caterina R. Does optical coherence tomography identify arterial healing after stenting? An in vivo comparison with histology, in a rabbit carotid model. Heart 2008;94:217-221. (Pubitemid 351211734)
14. Murata A, Wallace-Bradley D, Tellez A, Alviar C, Aboodi M, Sheehy A, Coleman L, Perkins L, Nakazawa G, Mintz G, Kaluza GL, Virmani R, Granada JF. Accuracy of optical coherence tomography in the evaluation of neointimal coverage after stent implantation. JACC Cardiovasc Imaging 2010;3:76-84.
15. Templin C, Meyer M, Muller MF, Djonov V, Hlushchuk R, Dimova I, Flueckiger S, Kronen P, Sidler M, Klein K, Nicholls F, Ghadri JR, Weber K, Paunovic D, Corti R, Hoerstrup SP, Luscher TF, Landmesser U. Coronary optical frequency domain imaging (OFDI) for in vivo evaluation of stent healing: comparison with light and electron microscopy. Eur Heart J 2010;31:1792-1801.
16. Barlis P, Regar E, Serruys PW, Dimopoulos K, van der Giessen WJ, van Geuns RJ, Ferrante G, Wandel S, Windecker S, Van Es GA, Eerdmans P, Juni P, di Mario C. An optical coherence tomography study of a biodegradable vs. durable polymercoated limus-eluting stent: a LEADERS trial sub-study. Eur Heart J 2010;31: 165-176.
17. Guagliumi G, Sirbu V, Musumeci G, Bezerra HG, Aprile A, Kyono H, Fiocca L, Matiashvili A, Lortkipanidze N, Vassileva A, Popma JJ, Allocco DJ, Dawkins KD, Valsecchi O, Costa MA. Strut coverage and vessel wall response to a newgeneration paclitaxel-eluting stent with an ultrathin biodegradable abluminal polymer: Optical Coherence Tomography Drug-Eluting Stent Investigation (OCTDESI). Circ Cardiovasc Interv 2010;3:367-375.
18. Guagliumi G, Sirbu V, Bezerra H, Biondi-Zoccai G, Fiocca L, Musumeci G, Matiashvili A, Lortkipanidze N, Tahara S, Valsecchi O, Costa M. Strut coverage and vessel wall response to zotarolimus-eluting and bare-metal stents implanted in patients with ST-segment elevation myocardial infarction: the OCTAMI (Optical Coherence Tomography in Acute Myocardial Infarction) Study. JACC Cardiovasc Interv 2010;3:680-687.
19. Cook S, Ladich E, Nakazawa G, Eshtehardi P, Neidhart M, Vogel R, Togni M, Wenaweser P, Billinger M, Seiler C, Gay S, Meier B, Pichler WJ, Juni P, Virmani R, Windecker S. Correlation of intravascular ultrasound findings with histopathological analysis of thrombus aspirates in patients with very late drug-eluting stent thrombosis. Circulation 2009;120:391-399.
20. Windecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, Lenk K, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, Di MC, Davies S, van Geuns RJ, Eerdmans P, Van Es GA, Meier B, Juni P. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial. Lancet 2008;372:1163-1173.
21. Udipi K, Melder RJ, Chen M, Cheng P, Hezi-Yamit A, Sullivan C,Wong J, Wilcox J. The next generation Endeavor Resolute Stent: role of the BioLinx Polymer System. EuroIntervention 2007;3:137-139.
22. Udipi K, Chen M, Cheng P, Jiang K, Judd D, Caceres A, Melder RJ, Wilcox JN. Development of a novel biocompatible polymer system for extended drug release in a next-generation drug-eluting stent. J Biomed Mater Res A 2008;85: 1064-1071. (Pubitemid 351717975)
23. Hezi-Yamit A, Sullivan C, Wong J, David L, Chen M, Cheng P, Shumaker D, Wilcox JN, Udipi K. Impact of polymer hydrophilicity on biocompatibility: implication for DES polymer design. J Biomed Mater Res A 2009;90:133-141.
24. Rogers C, Welt FG, Karnovsky MJ, Edelman ER. Monocyte recruitment and neointimal hyperplasia in rabbits. Coupled inhibitory effects of heparin. Arterioscler Thromb Vasc Biol 1996;16:1312-1318. (Pubitemid 26339721)
25. Carter AJ, Melder RJ, Udipi K, Ozdil F, Virmani R, Wilcox J. In vivo performance of a novel co-polymer system for extended release of zotarolimus in a next generation drug-eluting stent. Presented at the Transcatheter Cardiovascular Therapeutics Annual Meeting, Washington, DC. 2006. Ref Type: Abstract.
26. Guidoin R, Marois Y, Zhang Z, King M, Martin L, Laroche G, Awad J. The benefits of fluoropassivation of polyester arterial prostheses as observed in a canine model. ASAIO J 1994;40:M870-M879. (Pubitemid 24364325)
27. 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;93:497-509.
28. Meredith IT, Worthley S, Whitbourn R, Walters D, Popma J, Cutlip D, Fitzgerald P. The next-generation Endeavor Resolute stent: 4-month clinical and angiographic results from the Endeavor Resolute first-in-man trial. EuroIntervention 2007;3:50-53.
29. Meredith IT, Worthley S, Whitbourn R, Walters DL, McClean D, Horrigan M, Popma JJ, Cutlip DE, DePaoli A, Negoita M, Fitzgerald PJ. Clinical and angiographic results with the next-generation resolute stent system: a prospective, multicenter, first-in-human trial. JACC Cardiovasc Interv 2009;2:977-985.
30. Meredith IT, Worthley S, Whitbourn R, Walters D, McClean D, Ormiston J, Horrigan M, Wilkins GT, Hendriks R, Matsis P, Muller D, Cutlip D. Long-term clinical outcomes with the next-generation Resolute Stent System: a report of the two-year follow-up from the RESOLUTE clinical trial. EuroIntervention 2010; 5:692-697.
31. Serruys PW, Silber S, Garg S, van Geuns RJ, Richardt G, Buszman PE, Kelbaek H, van Boven AJ, Hofma SH, Linke A, Klauss V, Wijns W, Macaya C, Garot P, DiMario C, Manoharan G, Kornowski R, Ischinger T, Bartorelli A, Ronden J, Bressers M, Gobbens P, Negoita M, van Leeuwen F, Windecker S. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N Engl J Med 2010;363:136-146.
32. Ruygrok PN, Desaga M, Van Den BF, Rasmussen K, Suryapranata H, Dorange C, Veldhof S, Serruys PW. One year clinical follow-up of the XIENCE V Everolimus-eluting stent system in the treatment of patients with de novo native coronary artery lesions: the SPIRIT II study. EuroIntervention 2007;3: 315-320.
33. Gonzalo N, Tearney GJ, Serruys PW, van Soest G, Okamura T, Garcia-Garcia HM, van Geuns RJ, van der Ent M, Ligthart JM, Bouma BE, Regar E. Second-generation optical coherence tomography in clinical practice. High-speed data acquisition is highly reproducible in patients undergoing percutaneous coronary intervention. Rev Esp Cardiol 2010;63:893-903.
34. Gonzalo N, Garcia-Garcia HM, Serruys PW, Commissaris KH, Bezerra H, Gobbens P, Costa M, Regar E. Reproducibility of quantitative optical coherence tomography for stent analysis. EuroIntervention 2009;5:224-232.
35. Guagliumi G, Musumeci G, Sirbu V, Bezerra HG, Suzuki N, Fiocca L, Matiashvili A, Lortkipanidze N, Trivisonno A, Valsecchi O, Biondi-Zoccai G, Costa MA. Optical coherence tomography assessment of in vivo vascular response after implantation of overlapping bare-metal and drug-eluting stents. JACC Cardiovasc Interv 2010;3: 531-539.
36. Guagliumi G, Costa MA, Sirbu V, Musumeci G, Bezerra HG, Suzuki N, Matiashvili A, Lortkipanidze N, Mihalcsik L, Trivisonno A, Valsecchi O, Mintz GS, Dressler O, Parise H, Maehara A, Cristea E, Lansky AJ, Mehran R, Stone GW. Strut coverage and late malapposition with paclitaxel-eluting stents compared with bare metal stents in acute myocardial infarction: optical coherence tomography substudy of the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) Trial. Circulation 2011;123:274-281.
37. Stone GW, Lansky AJ, Pocock SJ, Gersh BJ, Dangas G,Wong SC, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Mö ckel M, Ochala A, Kellock A, Parise H, Mehran R. Paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction. N Engl J Med 2009;360:1946-1959.
38. Tanaka N, Terashima M, Rathore S, Itoh T, Habara M, Nasu K, Kimura M, Itoh T, Kinoshita Y, Ehara M, Tsuchikane E, Asakura K, Asakura Y, Katoh O, Suzuki T. Different patterns of vascular response between patients with or without diabetes mellitus after drug-eluting stent implantation: optical coherence tomographic analysis. JACC Cardiovasc Interv 2010;3:1074-1079.
39. Duckers HJ, Silber S, de Winter R, den Heijer P, Rensing B, Rau M, Mudra H, Benit E, Verheye S, Wijns W, Serruys PW. Circulating endothelial progenitor cells predict angiographic and intravascular ultrasound outcome following percutaneous coronary interventions in the HEALING-II trial: evaluation of an endothelial progenitor cell capturing stent. EuroIntervention 2007;3:67-75.
40. Wentzel JJ, Krams R, Schuurbiers JC, Oomen JA, Kloet J, van der Giessen WJ, Serruys PW, Slager CJ. Relationship between neointimal thickness and shear stress after Wallstent implantation in human coronary arteries. Circulation 2001; 103:1740-1745. (Pubitemid 32291410)
41. Gijsen FJH, Oortman RM, Wentzel JJ, Schuurbiers JCH, Tanabe K, Degertekin M, Ligthart JM, Thury A, de Feyter PJ, Serruys PW, Slager CJ. Usefulness of shear stress pattern in predicting neointima distribution in sirolimus-eluting stents in coronary arteries. Am J Cardiol 2003;92:1325-1328. (Pubitemid 37431144)