title: Impact of sirolimus-eluting stent fracture on 4-year clinical outcomes.
abstract: BACKGROUND
  Although stent fracture (SF) after sirolimus-eluting stent (SES) implantation has been recognized as one of the predisposing factors of in-stent restenosis, it remains uncertain whether SF can increase the risk of major adverse cardiac events (MACE), especially beyond 1 year after SES implantation. The aim of this study was to assess the impact of SF relative to non-SF on 4-year clinical outcomes after treatment with SES of comparable unselected lesions.
  
  
  RESULTS
  A total of 874 lesions in 793 patients undergoing SES implantation and subsequent angiography 6 to 9 months after index procedure were analyzed. At 6- to 9-month angiographic follow-up, SF was identified in 70 of 874 lesions (8.0%). In-stent late loss was significantly higher in SF lesions versus non-SF lesions (0.42±0.59 mm versus 0.13±0.49 mm, P<0.001), resulting in a significantly higher in-stent restenosis rate (21.4% versus 4.1%, P<0.001). At 4 years, SF versus non-SF was associated with a significantly higher MACE rate (23.2% versus 12.6%, P=0.014), mainly driven by significantly higher target-lesion revascularization (18.8% versus 10.2%, P=0.029) rate. Adverse effects of SF on clinical outcomes occurred mostly within the first year (17.4% versus 6.6%, P=0.001), with similar MACE rate between 1 and 4 years (5.8% versus 5.9%, P=0.611). No significant differences between SF versus non-SF patients were observed in the cumulative frequency of very late stent thrombosis (2.9% versus 1.4%, P=0.281), death (0% versus 2.1%, P=0.252), or myocardial infarction (5.8% versus 2.9%, P=0.165).
  
  
  CONCLUSIONS
  SF of SES was associated with higher MACE rate up to 1 year, mainly driven by higher target-lesion revascularization, whereas no significant association was evident between years 1 and 4.
authors.affiliation: Division of Cardiology, Toyota Memorial Hospital, 1-1 Heiwa-cho, Toyota, Japan. hisashi_umeda_aa@mail.toyota.co.jp
authors.forename: Hisashi
authors.initials: H
authors.lastname: Umeda
authors.forename: Tomoko
authors.initials: T
authors.lastname: Kawai
authors.forename: Naoki
authors.initials: N
authors.lastname: Misumida
authors.forename: Tomoyuki
authors.initials: T
authors.lastname: Ota
authors.forename: Kazutaka
authors.initials: K
authors.lastname: Hayashi
authors.forename: Mitsunori
authors.initials: M
authors.lastname: Iwase
authors.forename: Hideo
authors.initials: H
authors.lastname: Izawa
authors.forename: Shigeo
authors.initials: S
authors.lastname: Sugino
authors.forename: Takeshi
authors.initials: T
authors.lastname: Shimizu
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Takeichi
authors.forename: Ryoji
authors.initials: R
authors.lastname: Ishiki
authors.forename: Haruo
authors.initials: H
authors.lastname: Inagaki
authors.forename: Yukio
authors.initials: Y
authors.lastname: Ozaki
authors.forename: Toyoaki
authors.initials: T
authors.lastname: Murohara
mesh_terms: D000368:Aged; D019917:Blood Vessel Prosthesis Implantation; D023903:Coronary Restenosis / Q000453:epidemiology* / Q000209:etiology*; D054855:Drug-Eluting Stents / Q000706:statistics & numerical data; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011475:Prosthesis Failure / Q000009:adverse effects*; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D020123:Sirolimus