Long-term safety and efficacy of sirolimus-eluting stents in japanese patients

A single-center cohort study

Michinari Nakamura, Takeshi Yamashita, Junji Yajima, Yuji Oikawa, Ken Ogasawara, Hajime Kirigaya, Kazuyuki Nagashima, Hitoshi Sawada, Tadanori Aizawa

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)526-531
Number of pages6
JournalJournal of Invasive Cardiology
Volume21
Issue number10
StatePublished - Oct 1 2009

Fingerprint

Sirolimus
Stents
Cohort Studies
Safety
Metals
Economic Inflation
Japan
Myocardial Infarction
Confidence Intervals
Pressure
Mortality
Incidence
Cerebral Hemorrhage

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine
  • Radiology Nuclear Medicine and imaging

Keywords

  • Cohort study
  • Intravascular ultrasound
  • Japanese
  • Sirolimus-eluting stents

Cite this

Nakamura, M., Yamashita, T., Yajima, J., Oikawa, Y., Ogasawara, K., Kirigaya, H., ... Aizawa, T. (2009). Long-term safety and efficacy of sirolimus-eluting stents in japanese patients: A single-center cohort study. Journal of Invasive Cardiology, 21(10), 526-531.
Nakamura, Michinari ; Yamashita, Takeshi ; Yajima, Junji ; Oikawa, Yuji ; Ogasawara, Ken ; Kirigaya, Hajime ; Nagashima, Kazuyuki ; Sawada, Hitoshi ; Aizawa, Tadanori. / Long-term safety and efficacy of sirolimus-eluting stents in japanese patients : A single-center cohort study. In: Journal of Invasive Cardiology. 2009 ; Vol. 21, No. 10. pp. 526-531.
@article{7e826db632af4431811455d5e07fdd91,
title = "Long-term safety and efficacy of sirolimus-eluting stents in japanese patients: A single-center cohort study",
abstract = "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.",
keywords = "Cohort study, Intravascular ultrasound, Japanese, Sirolimus-eluting stents",
author = "Michinari Nakamura and Takeshi Yamashita and Junji Yajima and Yuji Oikawa and Ken Ogasawara and Hajime Kirigaya and Kazuyuki Nagashima and Hitoshi Sawada and Tadanori Aizawa",
year = "2009",
month = "10",
day = "1",
language = "English (US)",
volume = "21",
pages = "526--531",
journal = "Journal of Invasive Cardiology",
issn = "1042-3931",
publisher = "HMP Communications",
number = "10",

}

Nakamura, M, Yamashita, T, Yajima, J, Oikawa, Y, Ogasawara, K, Kirigaya, H, Nagashima, K, Sawada, H & Aizawa, T 2009, 'Long-term safety and efficacy of sirolimus-eluting stents in japanese patients: A single-center cohort study', Journal of Invasive Cardiology, vol. 21, no. 10, pp. 526-531.

Long-term safety and efficacy of sirolimus-eluting stents in japanese patients : A single-center cohort study. / Nakamura, Michinari; Yamashita, Takeshi; Yajima, Junji; Oikawa, Yuji; Ogasawara, Ken; Kirigaya, Hajime; Nagashima, Kazuyuki; Sawada, Hitoshi; Aizawa, Tadanori.

In: Journal of Invasive Cardiology, Vol. 21, No. 10, 01.10.2009, p. 526-531.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Long-term safety and efficacy of sirolimus-eluting stents in japanese patients

T2 - A single-center cohort study

AU - Nakamura, Michinari

AU - Yamashita, Takeshi

AU - Yajima, Junji

AU - Oikawa, Yuji

AU - Ogasawara, Ken

AU - Kirigaya, Hajime

AU - Nagashima, Kazuyuki

AU - Sawada, Hitoshi

AU - Aizawa, Tadanori

PY - 2009/10/1

Y1 - 2009/10/1

N2 - 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.

AB - 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.

KW - Cohort study

KW - Intravascular ultrasound

KW - Japanese

KW - Sirolimus-eluting stents

UR - http://www.scopus.com/inward/record.url?scp=72649084964&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=72649084964&partnerID=8YFLogxK

M3 - Article

VL - 21

SP - 526

EP - 531

JO - Journal of Invasive Cardiology

JF - Journal of Invasive Cardiology

SN - 1042-3931

IS - 10

ER -