title: Mid-term results of everolimus-eluting stent in a Japanese population compared with a US randomized cohort: SPIRIT III Japan Registry with harmonization by doing.
abstract: To address safety concerns with first-generation drug-eluting stents (DESs), the everolimus-eluting stent (EES) has been developed as a second-generation DES. The study aim was to: (1) demonstrate that use of the EES in Japanese patients is non-inferior to use of the paclitaxel-eluting stent (PES) in US patients; and (2) compare vessel response to the EES in Japanese vs US patients.
  
  
  METHODS
  The SPIRIT III Japan Registry, a prospective single-arm multicenter study was a part of the SPIRIT III global clinical program using harmonization by doing. The primary endpoint was in-segment late loss at 8 months, compared to US PES.
  
  
  RESULTS
  A total of 88 subjects were enrolled in the Japan EES group. Angiographic in-segment late loss was significantly less in Japan EES vs US PES (0.15 ± 0.34 mm vs 0.28 ± 0.48 mm, respectively; P=.0185; Pnon-inferio r<.0001), while target vessel failure (TVF; 8.0% vs 9.9%) and major adverse cardiac events (MACE) at 9 months (5.7% vs 8.8%) were not significantly different between the 2 groups. No differences were observed between Japan and US EES populations in terms of late loss, TVF, or MACE. Neointimal volume and postprocedural incomplete stent apposition rate were lower in Japan EES vs US EES/PES.
  
  
  CONCLUSIONS
  The SPIRIT III Japan Registry met the primary endpoint of lower late loss in the Japan EES group vs the US PES group, with comparable results for EES between the Japanese and US patients.
authors.affiliation: ShonanKamakura General Hospital, Kamakura, Japan. transradial@kamakuraheart.org
authors.forename: Shigeru
authors.initials: S
authors.lastname: Saito
authors.forename: Shigeru
authors.initials: S
authors.lastname: Nakamura
authors.forename: Kenshi
authors.initials: K
authors.lastname: Fujii
authors.forename: Masato
authors.initials: M
authors.lastname: Nakamura
authors.forename: Takaaki
authors.initials: T
authors.lastname: Isshiki
authors.forename: Haruo
authors.initials: H
authors.lastname: Hirayama
authors.forename: Tadashi
authors.initials: T
authors.lastname: Kikuchi
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Fujita
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Nonogi
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Mitsudo
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kimura
authors.forename: Keiichi
authors.initials: K
authors.lastname: Igarashi
authors.forename: Kumiko
authors.initials: K
authors.lastname: Saito
authors.forename: Alexandra J
authors.initials: AJ
authors.lastname: Lansky
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Honda
authors.forename: Katsuhisa
authors.initials: K
authors.lastname: Waseda
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Fitzgerald
authors.forename: Krishnankutty
authors.initials: K
authors.lastname: Sudhir
mesh_terms: D017023:Coronary Angiography / Q000379:methods*; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000601:surgery*; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D010975:Platelet Aggregation Inhibitors; D011446:Prospective Studies; D012042:Registries; D020123:Sirolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016019:Survival Analysis; D016896:Treatment Outcome; D014481:United States
chemical_list: D010975:Platelet Aggregation Inhibitors; D000068338:Everolimus; D017239:Paclitaxel; D020123:Sirolimus