title: Randomized trial of optimal treatment strategies for in-stent restenosis after drug-eluting stent implantation.
abstract: OBJECTIVE
  The purpose of this study is to compare the efficacy of the treatment strategies for in-stent restenosis (ISR) of drug-eluting stents (DES) according to the morphologic pattern of restenosis.
  
  
  BACKGROUND
  Optimal treatment strategies for ISR within DES have not been adequately addressed yet.
  
  
  METHODS
  Patients with ISR of DES were randomized according to the lesion length to compare outcomes of sirolimus-eluting stent (SES) versus cutting balloon angioplasty for focal type (≤10 mm) and SES versus everolimus-eluting stent (EES) for diffuse type (>10 mm). The primary endpoint was in-segment late loss at 9 months. Overall 162 patients, 96 with focal ISR and 66 with diffuse ISR, were enrolled.
  
  
  RESULTS
  In focal lesions, in-segment late loss was significantly higher in the cutting balloon group (n = 48) than in the SES group (n = 48; 0.25 mm, interquartile range [IQR]: -0.01 to 0.68 mm vs. 0.06 mm, IQR: -0.08 to 0.17 mm; p = 0.04). Consequently, in-segment restenosis rate tended to be higher in the cutting balloon group than in the SES group (20.7% vs. 3.1%, p = 0.06) with comparable incidences of the composite of death, myocardial infarction, or target vessel revascularization at 12 months of clinical follow up (6.3% vs. 6.3%, p > 0.99). In 66 cases of diffuse ISR, in-segment late loss (0.11 mm, IQR: -0.02 to 0.30 mm; vs. 0.00 mm, IQR: -0.08 to 0.25 mm; p = 0.64), in-segment restenosis rate (5.0% vs. 14.3%, p = 0.32), and the composite incidence of death, myocardial infarction, or target lesion revascularization (9.6% vs. 8.8%, p > 0.99) did not differ between SES group (n = 32) and EES group (n = 34).
  
  
  CONCLUSIONS
  For lesions of focal DES restenosis, repeat implantation of SES is more effective in reducing late luminal loss and subsequent restenosis rate than cutting balloon angioplasty. For diffuse DES restenosis, implantation of SES or EES is comparably effective in terms of angiographic and clinical outcomes.
authors.affiliation: Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
authors.forename: Hae-Geun
authors.initials: HG
authors.lastname: Song
authors.forename: Duk-Woo
authors.initials: DW
authors.lastname: Park
authors.forename: Young-Hak
authors.initials: YH
authors.lastname: Kim
authors.forename: Jung-Min
authors.initials: JM
authors.lastname: Ahn
authors.forename: Won-Jang
authors.initials: WJ
authors.lastname: Kim
authors.forename: Jong-Young
authors.initials: JY
authors.lastname: Lee
authors.forename: Soo-Jin
authors.initials: SJ
authors.lastname: Kang
authors.forename: Seung-Whan
authors.initials: SW
authors.lastname: Lee
authors.forename: Cheol Whan
authors.initials: CW
authors.lastname: Lee
authors.forename: Seong-Wook
authors.initials: SW
authors.lastname: Park
authors.forename: Seungbong
authors.initials: S
authors.lastname: Han
authors.forename: In-Whan
authors.initials: IW
authors.lastname: Seong
authors.forename: Nae-Hee
authors.initials: NH
authors.lastname: Lee
authors.forename: Bong-Ki
authors.initials: BK
authors.lastname: Lee
authors.forename: Keun
authors.initials: K
authors.lastname: Lee
authors.forename: Seung-Wook
authors.initials: SW
authors.lastname: Lee
authors.forename: Deuk-Young
authors.initials: DY
authors.lastname: Nah
authors.forename: Seung-Jung
authors.initials: SJ
authors.lastname: Park
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D015986:Confounding Factors, Epidemiologic; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000150:complications / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D054855:Drug-Eluting Stents; D004562:Electrocardiography; D000068338:Everolimus; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D011446:Prospective Studies; D012086:Reoperation; D056910:Republic of Korea; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D007166:Immunosuppressive Agents; D000068338:Everolimus; D020123:Sirolimus