title: 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).
abstract: At present no proven standard treatment for drug-eluting stent (DES) restenosis is available, and the efficacy and safety of everolimus-eluting stent (EES) and zotarolimus-eluting stent (ZES) for DES restenosis are limited. The purpose of this prospective, randomized 9-month intracoronary ultrasound (IVUS) and 3-year clinical follow-up study was to compare the effects of EESs and ZESs on neointima volume and major adverse cardiovascular events (MACEs) such as death, myocardial infarction (MI), target lesion revascularization (TLR) and stent thrombosis in DES restenosis patients.
  
  
  
  Patients were eligible for this study if they were between 40 and 75 years old with in-stent restenosis >50% by quantitative coronary angiographic analysis in DES or within 5 mm of the stent edges with signs of ischaemia. Eligible patients (n = 304, 146 women and 158 men) were randomly assigned to receive either EES (158 patients) or ZES (146 patients). The primary endpoint of the study was to compare neointima volume between the EES and ZES groups at the 9-month follow-up IVUS. MACEs, including death, non-fatal MI, stent thrombosis and the need for repeated TLR within 3 years, were noted. The 9-month angiographic and IVUS follow-up showed no significant differences in late lumen loss (0.40 ± 0.56 vs. 0.45 ± 0.61 mm, P = 0.57, respectively) and neointima volume (0.51 ± 0.48 vs. 0.56 ± 0.54 mm3/1 mm, P = 0.47, respectively) in the EES and the ZES groups. Composite MACEs such as death, MI, stent thrombosis and TLR during 3-year follow-up were comparable between the two groups [15.8% (n = 25) in the EES group and 22.6% (n = 33) in the ZES group, P = 0.276], independent of de novo DES type, sex, age, body mass index, presence of diabetes, hypertension and dyslipidaemia.
  
  
  
  Patients with first- and second-generation DES restenosis, both EES and ZES implantation were effective and safe in reducing neointima volume and late loss with a comparable rate of MACEs independent of cardiovascular risk factors.
authors.affiliation: Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, 126-1, 5ka, Anam-dong, Sungbuk-ku, Seoul 136-705, Korea.
authors.forename: Soon Jun
authors.initials: SJ
authors.lastname: Hong
authors.affiliation: Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, 126-1, 5ka, Anam-dong, Sungbuk-ku, Seoul 136-705, Korea.|Severance Cardiovascular Hospital, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul 120-752, Korea.
authors.forename: Chul Min
authors.initials: CM
authors.lastname: Ahn
authors.affiliation: Severance Cardiovascular Hospital, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul 120-752, Korea.
authors.forename: Byeong-Keuk
authors.initials: BK
authors.lastname: Kim
authors.affiliation: Severance Cardiovascular Hospital, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul 120-752, Korea.
authors.forename: Young-Guk
authors.initials: YG
authors.lastname: Ko
authors.affiliation: Keimyung University Dongsan Medical Center, 56 Dalseong-Ro, Jung-Gu, Daegu 700-712 Korea.
authors.forename: Seung-Ho
authors.initials: SH
authors.lastname: Hur
authors.affiliation: Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, 126-1, 5ka, Anam-dong, Sungbuk-ku, Seoul 136-705, Korea.
authors.forename: Cheol Woong
authors.initials: CW
authors.lastname: Yu
authors.affiliation: Soonchunhyang University Medical Center, 23-20, Byeongmyeong-dong, Dongnam-gu, Cheonan, Chungcheongnam-do 31151, Korea.
authors.forename: Seung-Jin
authors.initials: SJ
authors.lastname: Lee
authors.affiliation: Korea University Guro Hospital, 148, Gurodong-ro, Guro-gu, Seoul 08308, Korea.
authors.forename: Cheol Ung
authors.initials: CU
authors.lastname: Choi
authors.affiliation: Sejong General Hospital, Sosabon-dong, Sosa-gu, Bucheon-si, Gyeonggi-do 14754, Korea.
authors.forename: Je Sang
authors.initials: JS
authors.lastname: Kim
authors.affiliation: Yonsei University Wonju College of Medicine, Wonju Christian Hospital, 20 Ilsan-ro, Wonju, Gangwon-do, Wonju 220-701, Korea.
authors.forename: Jung-Han
authors.initials: JH
authors.lastname: Yoon
authors.affiliation: Chonnam National University Hospital, 77 Yongbong-ro, Buk-gu, Gwangju 500-757, Korea.
authors.forename: Young Joon
authors.initials: YJ
authors.lastname: Hong
authors.affiliation: Eulji General Hospital, 68 Hangeulbiseok-Ro, Nowon-Gu, Seoul 01830, Korea.
authors.forename: Jae-Woong
authors.initials: JW
authors.lastname: Choi
authors.affiliation: Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, Korea.
authors.forename: Seung-Hyuk
authors.initials: SH
authors.lastname: Choi
authors.affiliation: Severance Cardiovascular Hospital, Yonsei University, 50-1, Yonsei-ro, Seodaemun-gu, Seoul 120-752, Korea dslmd@kumc.or.kr jangys1212@yuhs.or.kr.
authors.forename: Yangsoo
authors.initials: Y
authors.lastname: Jang
authors.affiliation: Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, 126-1, 5ka, Anam-dong, Sungbuk-ku, Seoul 136-705, Korea dslmd@kumc.or.kr jangys1212@yuhs.or.kr.
authors.forename: Do-Sun
authors.initials: DS
authors.lastname: Lim
mesh_terms: D023903:Coronary Restenosis; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D062645:Percutaneous Coronary Intervention; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D020123:Sirolimus / Q000031:analogs & derivatives; D016896:Treatment Outcome
chemical_list: D000068338:Everolimus; C489443:zotarolimus; D020123:Sirolimus
keywords: Everolimus ; Neointima ; Restenosis; Zotarolimus 