Very late stent thrombosis and late target lesion revascularization after sirolimus-eluting stent implantation: five-year outcome of the j-Cypher Registry.
BACKGROUND
There is a scarcity of long-term data from large-scale drug-eluting stent registries with a large enough sample to evaluate low-frequency events such as stent thrombosis (ST).


RESULTS
Five-year outcomes were evaluated in 12 812 consecutive patients undergoing sirolimus-eluting stent (SES) implantation in the j-Cypher registry. Cumulative incidence of definite ST was low (30 day, 0.3%; 1 year, 0.6%; and 5 years, 1.6%). However, late and very late ST continued to occur without attenuation up to 5 years after sirolimus-eluting stent implantation (0.26%/y). Cumulative incidence of target lesion revascularization within the first year was low (7.3%). However, late target lesion revascularization beyond 1 year also continued to occur without attenuation up to 5 years (2.2%/y). Independent risk factors of ST were completely different according to the timing of ST onset, suggesting the presence of different pathophysiological mechanisms of ST according to the timing of ST onset: acute coronary syndrome and target of proximal left anterior descending coronary artery for early ST; side-branch stenting, diabetes mellitus, and end-stage renal disease with or without hemodialysis for late ST; and current smoking and total stent length >28 mm for very late ST. Independent risk factors of late target lesion revascularization beyond 1 year were generally similar to those risk factors identified for early target lesion revascularization.


CONCLUSIONS
Late adverse events such as very late ST and late target lesion revascularization are continuous hazards, lasting at least up to 5 years after implantation of the first-generation drug-eluting stents (sirolimus-eluting stents), which should be the targets for developing improved coronary stents.
Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan. taketaka@kuhp.kyoto-ua.ac.jp
Takeshi
T
Kimura
Takeshi
T
Morimoto
Yoshihisa
Y
Nakagawa
Kazuya
K
Kawai
Shunichi
S
Miyazaki
Toshiya
T
Muramatsu
Nobuo
N
Shiode
Masanobu
M
Namura
Takahito
T
Sone
Shigeru
S
Oshima
Hideo
H
Nishikawa
Yoshikazu
Y
Hiasa
Yasuhiko
Y
Hayashi
Masakiyo
M
Nobuyoshi
Kazuaki
K
Mitudo
D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000379:methods / Q000401:mortality*; D023903:Coronary Restenosis / Q000401:mortality*; D003328:Coronary Thrombosis / Q000401:mortality*; D016757:Death, Sudden, Cardiac / Q000453:epidemiology; D054855:Drug-Eluting Stents / Q000009:adverse effects* / Q000706:statistics & numerical data; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D015994:Incidence; D007564:Japan / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D012042:Registries / Q000706:statistics & numerical data*; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage*; D013997:Time Factors
D007166:Immunosuppressive Agents; D020123:Sirolimus