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急性心肌梗死患者中使用西罗莫司和紫杉醇洗脱支架的长期安全性和有效性:四年观察研究。

Long-term safety and efficacy of sirolimus- and Paclitaxel-eluting stents in patients with acute myocardial infarction: four-year observational study.

机构信息

Department of Cardiology, Chungnam National University School of Medicine, Daejeon, Korea.

出版信息

Korean Circ J. 2012 Apr;42(4):266-73. doi: 10.4070/kcj.2012.42.4.266. Epub 2012 Apr 26.

Abstract

BACKGROUND AND OBJECTIVES

The comparison of long-term clinical effects between Sirolimus-eluting stent (SES) and Paclitaxel-eluting stents (PES) for treatment of acute myocardial infarction (AMI) remains unclear. Seeking to clarify this issue, we performed a retrospective analysis to evaluate four-year clinical outcomes of SES compared to PES treated AMI patients.

SUBJECTS AND METHODS

From January 2004 to August 2006, all patients with acute ST-segment elevation myocardial infarction and acute non-ST segment elevation myocardial infarction who underwent percutaneous coronary intervention (PCI) by implantation of either SES or PES were enrolled. The occurrences of cardiac and non-cardiac deaths, recurrent infarction, target vessel revascularization (TVR) and stent thrombosis were analyzed. The composite end points of these major adverse cardiac events (MACE) were also analyzed.

RESULTS

During the study period, a total of 668 AMI patients had visited, of which 522 patients (299 with SES and 223 with PES) were enrolled. During the four-year clinical follow-up, both groups showed similar occurrences of non-cardiac death (14.6±2.2% vs. 18.3±3.0%, p=0.26); cardiac death (6.8±1.52% vs. 11.2±2.6%, p=0.39); re-infarction (3.3±1.1% vs. 6.4±1.8%, p=0.31); and stent thrombosis (3.2±1.1% vs. 5.4±1.7%, p=0.53). However, occurrences of TVR {4.0±1.2% vs. 10.0±3.0%, hazard ratio (HR)=0.498, 95% confidence interval (CI)=0.257-0.967, p=0.039} and MACE (19.4±2.5% vs. 29.4±3.5%, HR=0.645, 95% CI=0.443-0.940, p=0.021) were significantly lower in the SES population.

CONCLUSION

In AMI patients treated with either SES or PES implantation, the former had a significantly lower risk of TVR and MACE during four-year clinical follow-up. Rates of death, cardiac death or recurrent infarction, and stent thrombosis were similar.

摘要

背景和目的

比较西罗莫司洗脱支架(SES)和紫杉醇洗脱支架(PES)治疗急性心肌梗死(AMI)的长期临床效果仍不清楚。为了阐明这一问题,我们进行了一项回顾性分析,以评估 SES 与 PES 治疗 AMI 患者的 4 年临床结局。

受试者和方法

2004 年 1 月至 2006 年 8 月,所有接受经皮冠状动脉介入治疗(PCI)植入 SES 或 PES 的急性 ST 段抬高型心肌梗死和急性非 ST 段抬高型心肌梗死患者均纳入研究。分析心脏和非心脏死亡、再梗死、靶血管血运重建(TVR)和支架血栓形成的发生情况。还分析了这些主要不良心脏事件(MACE)的复合终点。

结果

研究期间共就诊 668 例 AMI 患者,其中 522 例(SES 组 299 例,PES 组 223 例)入选。在 4 年的临床随访中,两组非心脏死亡发生率相似(14.6±2.2%比 18.3±3.0%,p=0.26);心脏死亡(6.8±1.52%比 11.2±2.6%,p=0.39);再梗死(3.3±1.1%比 6.4±1.8%,p=0.31);支架血栓形成(3.2±1.1%比 5.4±1.7%,p=0.53)。然而,TVR 的发生率{4.0±1.2%比 10.0±3.0%,风险比(HR)=0.498,95%置信区间(CI)=0.257-0.967,p=0.039}和 MACE(19.4±2.5%比 29.4±3.5%,HR=0.645,95%CI=0.443-0.940,p=0.021)在 SES 组中显著降低。

结论

在接受 SES 或 PES 植入治疗的 AMI 患者中,前者在 4 年临床随访期间 TVR 和 MACE 的风险显著降低。死亡率、心脏死亡率或再梗死率和支架血栓形成率相似。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9e5c/3341424/76cbe78e3f90/kcj-42-266-g001.jpg

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