title: Three-Year Clinical Outcomes of Everolimus-Eluting Stents From the Post-Marketing Surveillance Study of Cobalt-Chromium Everolimus-Eluting Stent (XIENCE V/PROMUS) in Japan.
abstract: BACKGROUND
  The Cobalt-Chromium Everolimus-Eluting Stent (CoCr-EES) Post-marketing Surveillance (PMS) is a prospective multicenter registry designed to evaluate the safety and efficacy of XIENCE V/PROMUS everolimus-eluting stents in routine clinical practice at 47 centers representative of the clinical environment in Japan.
  
  
  RESULTS
  We enrolled 2,010 consecutive patients (2,649 lesions) who underwent PCI using CoCr-EES. Clinical outcomes were evaluated for up to 3 years. Clinical follow-up was available in 1,930 patients (96%) at 3 years. Major adverse cardiovascular events (MACE) occurred in 6.8% of patients, including cardiac death (1.7%), myocardial infarction (1.5%), and clinically driven target lesion revascularization (CD-TLR, 4.2%). Late CD-TLR rate was 0.8% from 1 to 2 years, and 0.5% from 2 to 3 years. Definite or probable stent thrombosis occurred in 7 patients (0.3%) up to 1 year. There was no very late definite or probable stent thrombosis from 1 to 3 years. Significant independent predictors for MACE were hemodialysis, prior coronary intervention, triple-vessel coronary artery disease, and age >70 years.
  
  
  CONCLUSIONS
  Three-year clinical outcomes from the CoCr-EES PMS demonstrated a low incidence of clinical events. There was no major concern about very late stent thrombosis or late catch-up phenomenon in patients treated with EES in routine clinical practice in Japan.
authors.affiliation: Division of Cardiology, Mitsui Memorial Hospital.
authors.forename: Jiro
authors.initials: J
authors.lastname: Aoki
authors.forename: Ken
authors.initials: K
authors.lastname: Kozuma
authors.forename: Masaki
authors.initials: M
authors.lastname: Awata
authors.forename: Mamoru
authors.initials: M
authors.lastname: Nanasato
authors.forename: Nobuo
authors.initials: N
authors.lastname: Shiode
authors.forename: Kengo
authors.initials: K
authors.lastname: Tanabe
authors.forename: Junichi
authors.initials: J
authors.lastname: Yamaguchi
authors.forename: Hajime
authors.initials: H
authors.lastname: Kusano
authors.forename: Hong
authors.initials: H
authors.lastname: Nie
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kimura
mesh_terms: D000368:Aged; D002858:Chromium Alloys; D003324:Coronary Artery Disease / Q000453:epidemiology* / Q000601:surgery*; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007564:Japan; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D013927:Thrombosis / Q000453:epidemiology / Q000209:etiology
chemical_list: D002858:Chromium Alloys; D000068338:Everolimus