Prospective randomized comparison of clinical and angiographic outcomes between everolimus-eluting vs. zotarolimus-eluting stents for treatment of coronary restenosis in drug-eluting stents:Intravascular ultrasound volumetric analysis (RESTENT-ISR trial)

European Heart Journal

Volumn 37, Issue 45, 2016, Pages 3409-3418

  Hong, Soon Jun ^a   Ahn, Chul Min ^a,b   Kim, Byeong Keuk ^b   Ko, Young Guk ^b   Hur, Seung Ho ^c   Yu, Cheol Woong ^a   Lee, Seung Jin ^d   Choi, Cheol Ung ^e   Kim, Je Sang ^f   Yoon, Je Sang ^g   Hong, Young Joon ^h   Choi, Jae Woong ⁱ   Choi, Seung Hyuk ^j   Jang, Yangsoo ^b   Lim, Do Sun ^a  

^a College of Medicine   (South Korea)

^b Yonsei University College of Medicine   (South Korea)

^c Dongsan Medical Center   (South Korea)

^d Soonchunhyang University   (South Korea)

^e Korea University College of Medicine   (South Korea)

^f Sejong General Hospital   (South Korea)

^g Yonsei University Wonju College of Medicine   (South Korea)

^h Chonnam National University Medical School   (South Korea)

ⁱ Eulji General Hospital   (South Korea)

^j Sungkyunkwan University School of Medicine   (South Korea)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; AGE; AGED; ARTICLE; BODY MASS; CARDIOVASCULAR DISEASE; CLINICAL OUTCOME; CONTROLLED STUDY; CORONARY ANGIOGRAPHY; CORONARY ARTERY RECANALIZATION; DIABETES MELLITUS; DRUG ELUTING STENT; DYSLIPIDEMIA; EVEROLIMUS ELUTING CORONARY STENT; FEMALE; FOLLOW UP; HUMAN; HYPERTENSION; IN-STENT RESTENOSIS; INTRAVASCULAR ULTRASOUND; INTRAVASCULAR ULTRASOUND SYSTEM; MAJOR CLINICAL STUDY; MALE; NEOINTIMA; PACLITAXEL ELUTING CORONARY STENT; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SEX DIFFERENCE; SIROLIMUS ELUTING CORONARY STENT; SMOKING; STENT THROMBOSIS; ZOTAROLIMUS ELUTING CORONARY STENT; ANALOGS AND DERIVATIVES; PERCUTANEOUS CORONARY INTERVENTION; PROSTHESIS DESIGN; RESTENOSIS; RISK FACTOR; TREATMENT OUTCOME;

EVEROLIMUS; RAPAMYCIN; ZOTAROLIMUS;

CORONARY RESTENOSIS; DRUG-ELUTING STENTS; EVEROLIMUS; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; PERCUTANEOUS CORONARY INTERVENTION; PROSPECTIVE STUDIES; PROSTHESIS DESIGN; RISK FACTORS; SIROLIMUS; TREATMENT OUTCOME;

EID: 85014605441     PISSN: 0195668X     EISSN: 15229645     Source Type: Journal    
DOI: 10.1093/eurheartj/ehw389     Document Type: Article

References (29)

1. Hong SJ, Kim MH, Cha KS, Park HS, Chae SC, Hur SH, Gwon HC, Bae JH, Lim DS. Comparison of three-year clinical outcomes between sirolimus-versus paclitaxel- eluting stents in diabetic patients: prospective randomized multicenter trial. Catheter Cardiovasc Interv 2010;76:924-933.
2. Mehilli J, Byrne RA, Tiroch K, Pinieck S, Schulz S, Kufner S, Massberg S, Laugwitz KL, Schomig A, Kastrati A, ISAR-DESIRE 2 Investigators. Randomized trial of paclitaxel- versus sirolimus-eluting stents for treatment of coronary restenosis in sirolimus-eluting stents: the ISAR-DESIRE 2 (Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for in-Stent Restenosis 2) Study. J Am Coll Cardiol 2010;55:2710-2716.
3. Chen KY, Rha SW, Wang L, Li YJ, Li GP, Choi CU, Park CG, Seo HS, Oh DJ, Jeong MH, Ahn YK, Hong TJ, Kim YJ, Chae SC, Hur SH, Seong IW, Chae JK, Cho MC, Bae JH, Choi DH, Jang YS, Chae IH, Kim HS, Kim CJ, Yoon JH, Ahn TH, Chung WS, Seung KB, Park SJ, Korea Acute Myocardial Infarction Registry I. One-year clinical outcomes of everolimus- versus sirolimus-eluting stents in patients with acute myocardial infarction. Int J Cardiol 2014;176:583-588.
4. Maeng M, Tilsted HH, Jensen LO, Krusell LR, Kaltoft A, Kelbaek H, Villadsen AB, Ravkilde J, Hansen KN, Christiansen EH, Aaroe J, Jensen JS, Kristensen SD, Botker HE, Thuesen L, Madsen M, Thayssen P, Sorensen HT, Lassen JF. Differential clinical outcomes after 1 year versus 5 years in a randomised comparison of zotarolimuseluting and sirolimus-eluting coronary stents (the SORT OUT III study): a multicentre, open-label, randomised superiority trial. Lancet 2014;383:2047-2056.
5. Dangas GD, Claessen BE, Caixeta A, Sanidas EA, Mintz GS, Mehran R. In-stent restenosis in the drug-eluting stent era. J Am Coll Cardiol 2010;56:1897-1907.
6. Farooq V, Gogas BD, Serruys PW. Restenosis: delineating the numerous causes of drug-eluting stent restenosis. Circ Cardiovasc Interv 2011;4:195-205.
7. Byrne RA, Neumann FJ, Mehilli J, Pinieck S, Wolff B, Tiroch K, Schulz S, Fusaro M, Ott I, Ibrahim T, Hausleiter J, Valina C, Pache J, Laugwitz KL, Massberg S, Kastrati A, Investigators I-D. Paclitaxel-eluting balloons, paclitaxel-eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3): a randomised, open-label trial. Lancet 2013;381:461-467.
8. Piccolo R, Galasso G, Piscione F, Esposito G, Trimarco B, Dangas GD, Mehran R. Meta-analysis of randomized trials comparing the effectiveness of different strategies for the treatment of drug-eluting stent restenosis. Am J Cardiol 2014;114:1339-1346.
9. Lee MS, Pessegueiro A, Zimmer R, Jurewitz D, Tobis J. Clinical presentation of patients with in-stent restenosis in the drug-eluting stent era. J Invasive Cardiol 2008;20:401-403.
10. Siontis GC, Stefanini GG, Mavridis D, Siontis KC, Alfonso F, Perez-Vizcayno MJ, Byrne RA, Kastrati A, Meier B, Salanti G, Juni P, Windecker S. Percutaneous coronary interventional strategies for treatment of in-stent restenosis: a network meta-analysis. Lancet 2015;386:655-664.
11. Giacoppo D, Gargiulo G, Aruta P, Capranzano P, Tamburino C, Capodanno D. Treatment strategies for coronary in-stent restenosis: systematic review and hierarchical Bayesian network meta-analysis of 24 randomised trials and 4880 patients. BMJ 2015;351:h5392.
12. Stone GW, Ellis SG, O'Shaughnessy CD, Martin SL, Satler L, McGarry T, Turco MA, Kereiakes DJ, Kelley L, Popma JJ, Russell ME, Investigators TVI. Paclitaxeleluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the TAXUS V ISR randomized trial. JAMA 2006;295:1253-1263.
13. Kufner S, Cassese S, Valeskini M, Neumann FJ, Schulz-Schupke S, Hoppmann P, Fusaro M, Schunkert H, Laugwitz KL, Kastrati A, Byrne RA, Investigators I-D. Long-term efficacy and safety of paclitaxel-eluting balloon for the treatment of drug-eluting stent restenosis: 3-year results of a randomized controlled trial. JACC Cardiovasc Interv 2015;8:877-884.
14. Alfonso F, Perez-Vizcayno MJ, Cardenas A, Garcia Del Blanco B, Garcia- Touchard A, Lopez-Minguez JR, Benedicto A, Masotti M, Zueco J, Iniguez A, Velazquez M, Moreno R, Mainar V, Dominguez A, Pomar F, Melgares R, Rivero F, Jimenez-Quevedo P, Gonzalo N, Fernandez C, Macaya C, Investigators RIS. A prospective randomized trial of drug-eluting balloons versus everolimus-eluting stents in patients with in-stent restenosis of drug-eluting stents: the RIBS IV randomized clinical trial. J Am Coll Cardiol 2015;66:23-33.
15. Mauri L, Hsieh WH, Massaro JM, Ho KK, D'Agostino R, Cutlip DE. Stent thrombosis in randomized clinical trials of drug-eluting stents. N Engl J Med 2007;356:1020-1029.
16. Ryan TJ, Bauman WB, Kennedy JW, Kereiakes DJ, King SB III, McCallister BD, Smith SC Jr, Ullyot DJ. Guidelines for percutaneous transluminal coronary angioplasty. A report of the American Heart Association/American College of Cardiology Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Committee on Percutaneous Transluminal Coronary Angioplasty). Circulation 1993;88:2987-3007.
17. Hong SJ, Choi SC, Kim JS, Shim WJ, Park SM, Ahn CM, Park JH, Kim YH, Lim DS. Low-dose versus moderate-dose atorvastatin after acute myocardial infarction: 8-month effects on coronary flow reserve and angiogenic cell mobilisation. Heart 2010;96:756-764.
18. Tsuchiya Y, Lansky AJ, Costa RA, Mehran R, Pietras C, Shimada Y, Sonoda S, Cristea E, Negoita M, Dangas GD, Moses JW, Leon MB, Fitzgerald PJ, Muller R, Storger H, Hauptmann KE, Grube E. Effect of everolimus-eluting stents in different vessel sizes (from the pooled FUTURE I and II trials). Am J Cardiol 2006;98:464-469.
19. Hong SJ, Kim ST, Kim TJ, Kim EO, Ahn CM, Park JH, Kim JS, Lee KM, Lim DS. Cellular and molecular changes associated with inhibitory effect of pioglitazone on neointimal growth in patients with type 2 diabetes after zotarolimus-eluting stent implantation. Arterioscler Thromb Vasc Biol 2010;30:2655-2665.
20. Abe M, Kimura T, Morimoto T, Taniguchi T, Yamanaka F, Nakao K, Yagi N, Kokubu N, Kasahara Y, Kataoka Y, Otsuka Y, Kawamura A, Miyazaki S, Nakao K, Horiuchi K, Ito A, Hoshizaki H, Kawaguchi R, Setoguchi M, Inada T, Kishi K, Sakamoto H, Morioka N, Imai M, Shiomi H, Nonogi H, Mitsudo K, j-Cypher Registry I. Sirolimus-eluting stent versus balloon angioplasty for sirolimus-eluting stent restenosis: insights from the j-Cypher Registry. Circulation 2010;122:42-51.
21. Garg S, Smith K, Torguson R, Okabe T, Slottow TL, Steinberg DH, Roy P, Xue Z, Gevorkian N, Satler LF, Kent KM, Suddath WO, Pichard AD, Waksman R. Treatment of drug-eluting stent restenosis with the same versus different drugeluting stent. Catheter Cardiovasc Interv 2007;70:9-14.
22. Cassese S, Byrne RA, Schulz S, Hoppman P, Kreutzer J, Feuchtenberger A, Ibrahim T, Ott I, Fusaro M, Schunkert H, Laugwitz KL, Kastrati A. Prognostic role of restenosis in 10 004 patients undergoing routine control angiography after coronary stenting. Eur Heart J 2015;36:94-99.
23. Authors/Task Force members, Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J 2014;35:2541-2619.
24. Mishkel GJ, Moore AL, Markwell S, Shelton MC, Shelton ME. Long-term outcomes after management of restenosis or thrombosis of drug-eluting stents. J Am Coll Cardiol 2007;49:181-184.
25. Kastrati A, Mehilli J, von Beckerath N, Dibra A, Hausleiter J, Pache J, Schuhlen H, Schmitt C, Dirschinger J, Schomig A, Investigators I-DS. Sirolimus-eluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: a randomized controlled trial. JAMA 2005;293:165-171.
26. Kang SJ, Mintz GS, Park DW, Lee SW, Kim YH, Whan Lee C, Han KH, Kim JJ, Park SW, Park SJ. Mechanisms of in-stent restenosis after drug-eluting stent implantation: intravascular ultrasound analysis. Circ Cardiovasc Interv 2011;4:9-14.
27. Lee JY, Park DW, Kim YH, Ahn JM, Kim WJ, Kang SJ, Lee SW, Lee CW, Park SW, Yun SC, Yang TH, Lee BK, Lee NH, Yang JY, Shin WY, Park HS, Kim KS, Hur SH, Lee SY, Park JS, Choi YS, Lee SU, Her SH, Park SJ. Comparison of biolimus A9-eluting (Nobori) and everolimus-eluting (Promus Element) stents in patients with de novo native long coronary artery lesions: a randomized Long Drug-Eluting Stent V trial. Circ Cardiovasc Interv 2014;7:322-329.
28. Lim KS, Jeong MH, Bae IH, Park DS, Kim JM, Kim JH, Cho DL, Sim DS, Park KH, Hong YJ, Ahn Y. Histopathological comparison among biolimus, zotarolimus and everolimus-eluting stents in porcine coronary restenosis model. Korean Circ J 2013;43:744-751.
29. Frangieh AH, Templin C, Binder RK. Optical coherence tomography follow-up after bioresorbable in metallic and metallic in bioresorbable stenting: tackling instent restenosis in the era of bioresorbable vascular scaffolds. Eur Heart J 2015;36:2183.