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创新研究(ST段抬高型心肌梗死患者即刻支架植入与延迟支架植入对梗死面积和微血管灌注的影响)

INNOVATION Study (Impact of Immediate Stent Implantation Versus Deferred Stent Implantation on Infarct Size and Microvascular Perfusion in Patients With ST-Segment-Elevation Myocardial Infarction).

作者信息

Kim Je Sang, Lee Hyun Jong, Woong Yu Cheol, Kim Yang Min, Hong Soon Jun, Park Jae Hyung, Choi Rak Kyeong, Choi Young Jin, Park Jin Sik, Kim Tae Hoon, Jang Ho-Jun, Joo Hyung Joon, Cho Sang-A, Ro Young Moo, Lim Do-Sun

机构信息

From the Division of Cardiology, Department of Internal Medicine (J.S.K., H.J.L., R.K.C., Y.J.C., J.S.P., T.H.K., H.-J.J., Y.M.R.) and Division of Radiology (Y.M.K.), Sejong General Hospital, Bucheon, Korea; and Division of Cardiology, Department of Internal Medicine, Korea University Anam Hospital, Korea University School of Medicine, Seoul (C.W.Y., S.J.H., J.H.P., H.J.J., S.-A.C., D.-S.L.).

出版信息

Circ Cardiovasc Interv. 2016 Dec;9(12). doi: 10.1161/CIRCINTERVENTIONS.116.004101.

DOI:10.1161/CIRCINTERVENTIONS.116.004101
PMID:27965296
Abstract

BACKGROUND

The aim of this study was to assess whether deferred stenting (DS) reduces infarct size and microvascular obstruction (MVO) compared with immediate stenting (IS) in primary percutaneous coronary intervention for ST-segment-elevation myocardial infarction.

METHODS AND RESULTS

From February 2013 to August 2015, 114 patients (mean age: 69 years) were randomized into the following 2 groups: DS with an intention to stent 3 to 7 days later or IS after primary reperfusion in 2 centers. The primary and secondary end points were infarct size and the incidence of MVO, respectively, assessed by cardiac magnetic resonance imaging at 30 days after primary reperfusion. The median time to the second procedure in the DS was 72.8 hours. Six patients in the DS group were crossed over to the IS group because of progression of dissection or safety concerns after randomization. In the intention-to-treat analysis, DS did not significantly reduce infarct size (15.0% versus 19.4%; P=0.112) and the incidence of MVO (42.6% versus 57.4%; P=0.196), compared with IS. However, in anterior wall myocardial infarction, infarct size (16.1% versus 22.7%; P=0.017) and the incidence of MVO (43.8% versus 70.3%; P=0.047) were significantly reduced in the DS group. There was no urgent revascularization event during deferral period.

CONCLUSIONS

A routine DS did not significantly reduce infarct size and MVO compared with IS, although it was safe. The beneficial effect of DS in patients with anterior myocardial infarction should be confirmed by larger randomized studies.

CLINICAL TRIAL REGISTRATION

URL: http://www.clinicaltrials.gov. Unique identifier: NCT02324348.

摘要

背景

本研究旨在评估在ST段抬高型心肌梗死的直接经皮冠状动脉介入治疗中,与即刻支架置入术(IS)相比,延迟支架置入术(DS)是否能减小梗死面积和微血管阻塞(MVO)。

方法与结果

2013年2月至2015年8月,114例患者(平均年龄:69岁)被随机分为以下两组:在两个中心,一组为计划在3至7天后进行支架置入的DS组,另一组为初次再灌注后即刻进行IS组。主要和次要终点分别为梗死面积和MVO发生率,在初次再灌注后30天通过心脏磁共振成像进行评估。DS组第二次手术的中位时间为72.8小时。DS组有6例患者因随机分组后夹层进展或安全问题而 crossover 至IS组。在意向性分析中,与IS组相比,DS组并未显著减小梗死面积(15.0%对19.4%;P = 0.112)和MVO发生率(42.6%对57.4%;P = 0.196)。然而,在前壁心肌梗死中,DS组的梗死面积(16.1%对22.7%;P = 0.017)和MVO发生率(43.8%对70.3%;P = 0.047)显著降低。延迟期内无紧急血运重建事件。

结论

与IS组相比,常规DS虽安全,但未显著减小梗死面积和MVO。DS对前壁心肌梗死患者的有益作用应通过更大规模的随机研究予以证实。

临床试验注册

网址:http://www.clinicaltrials.gov。唯一标识符:NCT02324348。

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