The Journal of invasive cardiology · 2009
Long-term safety and efficacy of sirolimus-eluting stents in Japanese patients: a single-center cohort study.
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Nakamura Michinari, Yamashita Takeshi, Yajima Junji, Oikawa Yuji, Ogasawara Ken, Kirigaya Hajime, Nagashima Kazuyuki, Sawada Hitoshi, Aizawa Tadanori
Аннотация
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.
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.