title: SPIRIT III JAPAN versus SPIRIT III USA: a comparative intravascular ultrasound analysis of the everolimus-eluting stent.
abstract: The aim of this study was to evaluate the vascular response after everolimus-eluting stent (EES) implantation in the SPIRIT III Japan Registry (JAPAN) compared to EES implantation in the SPIRIT III United States (USA) trial using serial intravascular ultrasound (IVUS) analysis. Data were obtained from the JAPAN and the randomized EES arm of the USA trial. Serial (postprocedure and 8-month follow-up) IVUS analysis was available in 199 lesions (JAPAN 82, USA 117) of 183 patients (JAPAN 73, USA 110). Although no difference was observed in vessel size in the reference segment between the 2 groups, postprocedure minimum lumen area and stent volume index were significantly greater in the JAPAN arm (minimum lumen area 5.8 +/- 2.2 vs 5.1 +/- 1.5 mm(2), p = 0.03; stent volume index 7.0 +/- 2.4 vs 6.3 +/- 1.7 mm(3)/mm, p = 0.03). Postprocedure incomplete stent apposition (ISA) was less frequently observed in the JAPAN arm (15.9% vs 33.3%, p = 0.006), possibly related to higher maximum balloon pressure and/or more postdilatation without excess tissue prolapse or edge dissection. In the JAPAN arm, percent neointimal obstruction and maximum percent cross-sectional narrowing were significantly lower at 8-month follow-up (percent neointimal obstruction 3.5 +/- 4.2% vs 6.8 +/- 6.4%, p = 0.0004). Late acquired ISA was infrequent in the 2 arms. In conclusion, comparative IVUS analysis between the JAPAN and USA arms showed more optimal stent deployment in the JAPAN arm as evidenced by the lower incidence of postprocedure ISA and larger minimum lumen area after the procedure. Moreover, there was less neointimal hyperplasia in patients with EES implants from the JAPAN arm compared to the USA arm.
authors.affiliation: Stanford University Medical Center, Stanford, California, USA.
authors.forename: Takao
authors.initials: T
authors.lastname: Shimohama
authors.forename: Junya
authors.initials: J
authors.lastname: Ako
authors.forename: Masao
authors.initials: M
authors.lastname: Yamasaki
authors.forename: Hiromasa
authors.initials: H
authors.lastname: Otake
authors.forename: Ichizo
authors.initials: I
authors.lastname: Tsujino
authors.forename: Takao
authors.initials: T
authors.lastname: Hasegawa
authors.forename: Daisaku
authors.initials: D
authors.lastname: Nakatani
authors.forename: Ryota
authors.initials: R
authors.lastname: Sakurai
authors.forename: Hyeonsoo
authors.initials: H
authors.lastname: Chang
authors.forename: Hajime
authors.initials: H
authors.lastname: Kusano
authors.forename: Katsuhisa
authors.initials: K
authors.lastname: Waseda
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Honda
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.forename: Shigeru
authors.initials: S
authors.lastname: Saito
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Fitzgerald
authors.forename: Krishnankutty
authors.initials: K
authors.lastname: Sudhir
mesh_terms: D000368:Aged; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging* / Q000473:pathology*; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D006801:Humans; D006965:Hyperplasia / Q000000981:diagnostic imaging; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D007564:Japan; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives; D018084:Ultrasonography, Interventional; D014481:United States
chemical_list: D007166:Immunosuppressive Agents; D000068338:Everolimus; D020123:Sirolimus