Department of Cardiology, Saitama Prefecture Cardiovascular Respiratory Center, Saitama, Japan.
J Cardiol. 2011 Jan;57(1):44-52. doi: 10.1016/j.jjcc.2010.09.005. Epub 2010 Dec 10.
The long-term safety and efficacy of primary stenting using drug-eluting stents (DES) in patients with ST-segment elevation myocardial infarction (STEMI) are not fully understood in Japan. Therefore, we retrospectively examined the midterm clinical and angiographic outcomes in STEMI patients after primary stenting using sirolimus-eluting stents (SES) in a clinical setting through a historical comparison with those of bare-metal stents (BMS).
The study design was a retrospective, nonrandomized, and single-center study. The clinical outcomes for 568 consecutive patients who presented within 12 h of their first STEMI and who were treated with BMS (n = 198; 184 STEMIs from June 2003 to August 2004 and 14 STEMIs from September 2004 to May 2007) or SES (n = 370; from August 2004 to May 2007) at our medical center in Japan were retrospectively investigated in February 2010. The incidence of post-discharge events (comprising cardiac death and nonfatal recurrent MI) after SES placement (3.9%) was not significantly different from that after BMS placement (6.7%). SES was not related to the risk of post-discharge events (mean follow-up for SES, 1327 ± 415 days; BMS, 1818 ± 681 days) (hazard ratio of 0.369 at 95% CI, 0.119-1.147, p = 0.085). The incidence of definite stent thromboses after SES placement (0.54%) was not significantly higher than that after BMS placement (0%). The incidence of binary in-stent restenosis (% diameter stenosis of more than 50% at secondary angiography) after SES placement (8.3%) was significantly lower than that after BMS placement (25.7%; p < 0.001).
From the present historical comparison of SES and BMS, we conclude that primary stenting using SES in a clinical setting has favorable clinical and angiographic outcomes in Japanese STEMI patients.
在日本，关于 ST 段抬高型心肌梗死（STEMI）患者应用药物洗脱支架（DES）行直接经皮冠状动脉介入治疗（PCI）的长期安全性和疗效尚不完全清楚。因此，我们通过历史对照，回顾性分析了我院STEMI 患者应用西罗莫司洗脱支架（SES）行直接 PCI 的中期临床和血管造影结果。
研究设计为回顾性、非随机、单中心研究。我们于 2010 年 2 月对我院收治的 568 例发病 12 h 内的连续 STEMI 患者的临床资料进行了回顾性分析，这些患者分别接受了 BMS（n = 198；184 例 STEMI 患者于 2003 年 6 月至 2004 年 8 月接受治疗，14 例 STEMI 患者于 2004 年 9 月至 2007 年 5 月接受治疗）或 SES（n = 370；均于 2004 年 8 月至 2007 年 5 月接受治疗）治疗。SES 组（3.9%）和 BMS 组（6.7%）患者出院后心脏性死亡和非致死性再发心肌梗死（MI）的发生率均无显著差异。SES 组与 BMS 组的出院后事件（SES 组平均随访 1327 ± 415 天，BMS 组 1818 ± 681 天）风险比（HR）为 0.369（95%CI，0.119-1.147，p = 0.085）。SES 组（0.54%）和 BMS 组（0%）的明确支架血栓形成发生率均无显著差异。SES 组（8.3%）和 BMS 组（25.7%）的支架内再狭窄发生率（指再次血管造影时直径狭窄超过 50%的比例）差异有统计学意义（p < 0.001）。
通过 SES 与 BMS 的历史对照，我们认为 SES 行直接 PCI 治疗日本 STEMI 患者具有良好的临床和血管造影结果。
