ST段抬高型心肌梗死患者大冠状动脉中药物洗脱支架与裸金属支架的比较：ICAS注册研究结果

Drug-eluting versus bare-metal stents in large coronary arteries of patients with ST-segment elevation myocardial infarction: findings from the ICAS registry.

作者信息

Abe Daisuke, Sato Akira, Hoshi Tomoya, Maruta Shunsuke, Misaki Masako, Kakefuda Yuki, Watabe Hiroaki, Hiraya Daigo, Sakai Shunsuke, Kawabe Masayuki, Takeyasu Noriyuki, Aonuma Kazutaka

机构信息

Department of Cardiology, Ibaraki Prefectural Central Hospital, Tomobe, Japan.

Cardiovascular Division, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.

出版信息

J Cardiol. 2014 Nov;64(5):377-83. doi: 10.1016/j.jjcc.2014.02.020. Epub 2014 Mar 28.

DOI:10.1016/j.jjcc.2014.02.020

PMID:24685689

Abstract

BACKGROUND AND PURPOSE

There are a few retrospective subgroup analyses or registries of large-vessel (≥ 3.5mm) stenting. We investigated clinical outcomes of patients with ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES) and bare-metal stents (BMS) in large coronary vessels.

METHODS AND SUBJECTS

Of 1100 STEMI patients registered in the Ibaraki Cardiovascular Assessment Study (ICAS) multicenter registry from April 2007 to June 2012 who underwent PCI, we enrolled 454 patients (65.8 ± 12.7 years old, 81% male) with ≥ 3.5-mm stents. We excluded 53 patients with cardiogenic shock or left main trunk lesions. The remaining 401 patients were divided into Group-D, PCI with DES (n = 184), and Group-B, PCI with BMS (n = 217). Propensity score analysis matched 1:1 according to treatment with DES (n = 101) or with BMS (n = 101). We evaluated major adverse cardiac and cerebrovascular events (MACCE) and incidence of stent thrombosis (ST). MACCE was defined as all-cause death, myocardial infarction (MI), target-vessel revascularization (TVR), or cerebrovascular accident (CVA).

ESSENTIAL RESULTS

During a mean follow-up period of 526 days, all-cause death, MI, CVA, MACCE, and ST were not significantly different in Group-D versus Group-B (all-cause death: 4.35% vs. 4.61%, p = 0.90; MI: 0% vs. 0%; CVA: 2.72% vs. 3.23%, p = 0.76; MACCE: 15.2% vs. 20.3%, p = 0.19; and ST: 0.0% vs. 1.38%, p = 0.11). After adjusting for age, insulin use, multivessel disease, intra-aortic balloon pump use, culprit lesions, and estimated glomerular filtration rate <60 ml/min/1.73 m(2), MACCE was not significantly different between the groups (odds ratio: 0.69; 95% CI: 0.40-1.23; p = 0.21). However, TVR was significantly lower in Group-D than Group-B in Kaplan-Meier analysis (p = 0.048) after propensity score matching.

PRINCIPAL CONCLUSION

There was no advantage to using a DES in large vessels for preventing a hard endpoint, whereas DES use resulted in a significant reduction in TVR in the patients with STEMI in this registry.

摘要

背景与目的

关于大血管（≥3.5mm）支架置入术的回顾性亚组分析或登记研究较少。我们调查了接受药物洗脱支架（DES）和裸金属支架（BMS）经皮冠状动脉介入治疗（PCI）的ST段抬高型心肌梗死（STEMI）患者在大冠状动脉血管中的临床结局。

方法与研究对象

在2007年4月至2012年6月登记于茨城心血管评估研究（ICAS）多中心登记处且接受PCI的1100例STEMI患者中，我们纳入了454例（年龄65.8±12.7岁，81%为男性）置入≥3.5mm支架的患者。我们排除了53例心源性休克或左主干病变患者。其余401例患者分为D组（DES PCI，n = 184）和B组（BMS PCI，n = 217）。倾向评分分析根据DES（n = 101）或BMS（n = 101）治疗进行1:1匹配。我们评估了主要不良心脑血管事件（MACCE）和支架血栓形成（ST）的发生率。MACCE定义为全因死亡、心肌梗死（MI）、靶血管血运重建（TVR）或脑血管意外（CVA）。

主要结果

在平均526天的随访期内，D组与B组在全因死亡、MI、CVA、MACCE和ST方面无显著差异（全因死亡：4.35%对4.61%，p = 0.90；MI：0%对0%；CVA：2.72%对3.23%，p = 0.76；MACCE：15.2%对20.3%，p = 0.19；ST：0.0%对1.38%，p = 0.11）。在调整年龄、胰岛素使用情况、多支血管病变、主动脉内球囊泵使用情况、罪犯病变以及估计肾小球滤过率<60 ml/min/1.73 m²后，两组间MACCE无显著差异（比值比：0.69；95%置信区间：0.40 - 1.23；p = 0.21）。然而，在倾向评分匹配后的Kaplan-Meier分析中，D组的TVR显著低于B组（p = 0.048）。