title: Late adverse events after implantation of sirolimus-eluting stent and bare-metal stent: long-term (5-7 years) follow-up of the Coronary Revascularization Demonstrating Outcome study-Kyoto registry Cohort-2.
abstract: BACKGROUND
  Late adverse events such as very late stent thrombosis (VLST) or late target-lesion revascularization (TLR) after first-generation sirolimus-eluting stents (SES) implantation have not been yet fully characterized at long term in comparison with those after bare-metal stent (BMS) implantation.
  
  
  RESULTS
  Among 13 058 consecutive patients undergoing first percutaneous coronary intervention in the Coronary REvascularization Demonstrating Outcome study-Kyoto registry Cohort-2, 5078 patients were treated with SES only, and 5392 patients were treated with BMS only. During 7-year follow-up, VLST and late TLR beyond 1 year after SES implantation occurred constantly and without attenuation at 0.24% per year and at 2.0% per year, respectively. Cumulative 7-year incidence of VLST was significantly higher in the SES group than that in the BMS group (1.43% versus 0.68%, P<0.0001). However, there was no excess of all-cause death beyond 1 year in the SES group as compared with that in the BMS group (20.8% versus 19.6%, P=0.91). Cumulative incidences of late TLR (both overall and clinically driven) were also significantly higher in the SES group than in the BMS group (12.0% versus 4.1%, P<0.0001 and 8.5% versus 2.6%, P<0.0001, respectively), leading to late catch-up of the SES group to the BMS group regarding TLR through the entire 7-year follow-up (18.8% versus 25.2%, and 10.6% versus 10.2%, respectively). Clinical presentation as acute coronary syndrome was more common at the time of late SES TLR compared with early SES TLR (21.2% and 10.0%).
  
  
  CONCLUSIONS
  Late catch-up phenomenon regarding stent thrombosis and TLR was significantly more pronounced with SES than that with BMS. This limitation should remain the target for improvements of DES technology.
authors.affiliation: From the Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan (M. Natsuaki, S. Shizuta, H.S., T. Tada, J.T., Y.K., M.H., T. Kimura); Division of Genera Medicine, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan (T.M.); Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Kobe, Japan (Y.F., T. Kita); Division of Cardiology, Tenri Hospital, Tenri, Japan (Y.N.); Division of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan (K.K., K.M.); Division of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan (K.Y., K.A., M. Nobuyoshi); Division of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan (M.A.); Division of Cardiology, Japanese Red Cross Wakayama Medical Center, Wakayama, Japan (T. Tamura); Division of Cardiology, Nara Hospital, Kinki University Faculty of Medicine, Nara, Japan (M.S.); Division of Cardiology, Mitsubishi Kyoto Hospital, Kyoto, Japan (S.M.); Division of Cardiology, Kishiwada City Hospital, Kishiwada, Japan (M.M.); Division of Cardiology, Shimabara Hospital, Kyoto, Japan (M. Takahashi); Division of Cardiology, Kansai Electric Power Hospital, Osaka, Japan (K.I.); Division of Cardiology, Osaka Red Cross Hospital, Osaka, Japan (M. Tanaka); Division of Cardiology, Shimada Municipal Hospital, Shimada, Japan (T.A., R.H.); Division of Cardiology, Shizuoka General Hospital, Shizuoka, Japan (O.D., H.K.); Division of Cardiology, Maizuru Kyosai Hospital, Maizuru, Japan (M.K.); Division of Cardiology, Juntendo University Shizuoka Hospital, Shizuoka, Japan (S. Suwa); Division of Cardiology, Shizuoka City Shizuoka Hospital, Shizuoka, Japan (A.T.); Division of Cardiology, Hyogo Prefectural Amagasaki Hospital, Amagasaki, Japan (Y.T., H.F.); Division of Cardiology, Hamamatsu Rosai Hospital, Hamamatsu, Japan (E.S.); Division of Cardiology, Nishi-Kobe Medical Center, Kobe, Japan (H.E.); Division of Cardiology, Koto Memorial Hospital
authors.forename: Masahiro
authors.initials: M
authors.lastname: Natsuaki
authors.forename: Takeshi
authors.initials: T
authors.lastname: Morimoto
authors.forename: Yutaka
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authors.lastname: Furukawa
authors.forename: Yoshihisa
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authors.lastname: Nakagawa
authors.forename: Kazushige
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authors.lastname: Kadota
authors.forename: Kyohei
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authors.lastname: Yamaji
authors.forename: Kenji
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authors.lastname: Ando
authors.forename: Satoshi
authors.initials: S
authors.lastname: Shizuta
authors.forename: Hiroki
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authors.lastname: Shiomi
authors.forename: Tomohisa
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authors.lastname: Tada
authors.forename: Junichi
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authors.lastname: Tazaki
authors.forename: Yoshihiro
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authors.lastname: Kato
authors.forename: Mamoru
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authors.lastname: Hayano
authors.forename: Mitsuru
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authors.lastname: Abe
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authors.lastname: Tamura
authors.forename: Manabu
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authors.lastname: Shirotani
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authors.lastname: Miki
authors.forename: Mitsuo
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authors.lastname: Matsuda
authors.forename: Mamoru
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authors.lastname: Takahashi
authors.forename: Katsuhisa
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authors.lastname: Ishii
authors.forename: Masaru
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authors.lastname: Tanaka
authors.forename: Takeshi
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authors.lastname: Aoyama
authors.forename: Osamu
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authors.lastname: Doi
authors.forename: Ryuichi
authors.initials: R
authors.lastname: Hattori
authors.forename: Masayuki
authors.initials: M
authors.lastname: Kato
authors.forename: Satoru
authors.initials: S
authors.lastname: Suwa
authors.forename: Akinori
authors.initials: A
authors.lastname: Takizawa
authors.forename: Yoshiki
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authors.lastname: Takatsu
authors.forename: Eiji
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authors.lastname: Shinoda
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Eizawa
authors.forename: Teruki
authors.initials: T
authors.lastname: Takeda
authors.forename: Jong-Dae
authors.initials: JD
authors.lastname: Lee
authors.forename: Moriaki
authors.initials: M
authors.lastname: Inoko
authors.forename: Hisao
authors.initials: H
authors.lastname: Ogawa
authors.forename: Shuichi
authors.initials: S
authors.lastname: Hamasaki
authors.forename: Minoru
authors.initials: M
authors.lastname: Horie
authors.forename: Ryuji
authors.initials: R
authors.lastname: Nohara
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Kambara
authors.forename: Hisayoshi
authors.initials: H
authors.lastname: Fujiwara
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Mitsudo
authors.forename: Masakiyo
authors.initials: M
authors.lastname: Nobuyoshi
authors.forename: Toru
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authors.lastname: Kita
authors.forename: Takeshi
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authors.lastname: Kimura
mesh_terms: D000368:Aged; D015331:Cohort Studies; D003324:Coronary Artery Disease / Q000628:therapy*; D023903:Coronary Restenosis / Q000453:epidemiology* / Q000209:etiology; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007564:Japan; D008137:Longitudinal Studies; D008297:Male; D008670:Metals; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects*; D012042:Registries; D012189:Retrospective Studies; D020123:Sirolimus; D015607:Stents / Q000009:adverse effects*; D013927:Thrombosis / Q000453:epidemiology* / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D008670:Metals; D020123:Sirolimus
keywords: coronary artery disease; coronary restenosis; stents; thrombosis