title: Long-term (8-10 years) outcomes after biodegradable polymer-coated biolimus-eluting stent implantation.
abstract: Efficacy and safety data on biodegradable polymer-coated biolimus-eluting stent (BP-BES) are currently limited to 5 years. We evaluated longer term (8-10 years) clinical and angiographic outcomes after BP-BES implantation.
  
  
  
  Between 2005 and 2008, 243 patients (301 lesions) underwent BP-BES implantation. The primary clinical outcome measure was defined as any target lesion revascularisation (TLR). Absolute serial angiographic studies without any concomitant TLR within 2 years after the procedure were performed in 55 patients (65 lesions) at postprocedure, mid-term (within 1 year), late term (between 1 and 2 years) and very late term (beyond 2 years).
  
  
  
  The median follow-up duration was 9.4 years (IQR 8.2-10.2 years). The 8-year cumulative incidence of any TLR was 20.3%. The increase rate was approximately 7% per year in the first 2 years, but decelerated to approximately 1.2% per year beyond 2 years after the procedure. The minimal lumen diameter significantly decreased from postprocedure (2.63±0.44 mm) to mid-term (2.43±0.59 mm, p=0.002) and from late term (2.27±0.63 mm) to very late term (1.98±0.73 mm, p=0.002). The 8-year cumulative incidences of definite or probable stent thrombosis (ST) and major bleeding (Bleeding Academic Research Consortium (BARC) ≥3) were 0.5% and 12.0%, respectively. Definite ST was none within 10 years in the entire cohort.
  
  
  
  The long-term clinical outcomes after BP-BES implantation were favourable, although angiographic late progression of luminal narrowing did not reach a plateau. The incidence of ST remained notably low, whereas that of major bleeding gradually increased.
authors.affiliation: Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Okayama, Japan.
authors.forename: Masanobu
authors.initials: M
authors.lastname: Ohya
authors.affiliation: Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Okayama, Japan.
authors.forename: Shunsuke
authors.initials: S
authors.lastname: Kubo
authors.affiliation: Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Okayama, Japan.
authors.forename: Akimune
authors.initials: A
authors.lastname: Kuwayama
authors.affiliation: Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Okayama, Japan.
authors.forename: Katsuya
authors.initials: K
authors.lastname: Miura
authors.affiliation: Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Okayama, Japan.
authors.forename: Takenobu
authors.initials: T
authors.lastname: Shimada
authors.affiliation: Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Okayama, Japan.
authors.forename: Hidewo
authors.initials: H
authors.lastname: Amano
authors.affiliation: Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Okayama, Japan.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Hyodo
authors.affiliation: Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Okayama, Japan.
authors.forename: Suguru
authors.initials: S
authors.lastname: Otsuru
authors.affiliation: Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Okayama, Japan.
authors.forename: Seiji
authors.initials: S
authors.lastname: Habara
authors.affiliation: Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Okayama, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Tada
authors.affiliation: Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Okayama, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Tanaka
authors.affiliation: Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Okayama, Japan.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Fuku
authors.affiliation: Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Okayama, Japan.
authors.forename: Harumi
authors.initials: H
authors.lastname: Katoh
authors.affiliation: Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Okayama, Japan.
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Goto
authors.affiliation: Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Okayama, Japan.
authors.forename: Kazushige
authors.initials: K
authors.lastname: Kadota
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000601:surgery*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D005544:Forecasting; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D008297:Male; D009204:Myocardial Revascularization / Q000379:methods; D011108:Polymers; D011474:Prosthesis Design; D012189:Retrospective Studies; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000494:pharmacology; D016896:Treatment Outcome
chemical_list: D020099:Coated Materials, Biocompatible; D007166:Immunosuppressive Agents; D011108:Polymers; C518022:umirolimus; D020123:Sirolimus