Long-term safety and efficacy of sirolimus-eluting stents in Japanese patients: a single-center cohort study.
BACKGROUND
The long-term safety and efficacy of sirolimus-eluting stents (SES) remain uncertain in real practice in Japan.


METHODS
We used a hospital-based cohort (n = 6,562) comprising all the new patients who had visited our hospital between 2004 and 2007 to investigate the mortality and morbidity after SES or bare-metal stent (BMS) implantation.


RESULTS
Of the total, coronary artery disease was observed in 822 patients (12.5%), and SES or BMS were implanted in 208 and 167 patients, respectively. Patients receiving SES more often had diabetes but less often presented with acute myocardial infarction (MI). Median follow-up periods were 815 and 894 days for SES and BMS, respectively (p = 0.305). Intravascular ultrasound (IVUS) was used at a high rate (> 90%) in both groups, and maximum pressure inflation for SES was high at approximately 18 atm. The unadjusted cumulative incidence of all-cause death and major adverse cardiac events (MACE) (cardiac death, MI or target vessel revascularization) at 2 years was 4.3% versus 7.2% (p = 0.233) and 16.3% versus 32.9% (p < 0.001), respectively. In multivariate analysis, all-cause mortality was similar between SES (hazard ratio [HR] 0.981, 95% confidence interval [CI] 0.366-2.632) and BMS, but SES significantly reduced MACE (HR 0.468, 95% CI 0.280-0.784). Definite stent thrombosis set by the Academic Research Consortium was not observed in either group, and the incidence of cerebral hemorrhage was 0.5% in SES and 1.2% in BMS, respectively (p = 0.588).


CONCLUSIONS
SES used in real-world settings appeared to be safe and significantly associated with a lower risk of adverse events at long-term follow up in Japan, especially utilizing a careful stent deployment technique including high-pressure inflation and IVUS use.
Nakamura
Michinari
M
The Cardiovascular Institute, 7-3-10 Roppongi, Minato-ku, Tokyo, 106-0032, Japan. nmichi-kyu@umin.ac.jp
Yamashita
Takeshi
T
Yajima
Junji
J
Oikawa
Yuji
Y
Ogasawara
Ken
K
Kirigaya
Hajime
H
Nagashima
Kazuyuki
K
Sawada
Hitoshi
H
Aizawa
Tadanori
T
D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D002543:Cerebral Hemorrhage / Q000453:epidemiology; D015331:Cohort Studies; D003324:Coronary Artery Disease / Q000208:ethnology / Q000628:therapy*; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016016:Proportional Hazards Models; D012189:Retrospective Studies; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents / Q000009:adverse effects; D013927:Thrombosis / Q000453:epidemiology; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D020123:Sirolimus