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在 PRoximal Embolic Protection in Acute myocardial infarction and Resolution of ST-segment Elevation(PREPARE)试验中梗死面积和左心室功能:辅助心血管磁共振研究。

Infarct size and left ventricular function in the PRoximal Embolic Protection in Acute myocardial infarction and Resolution of ST-segment Elevation (PREPARE) trial: ancillary cardiovascular magnetic resonance study.

机构信息

Department of Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.

出版信息

Heart. 2010 Feb;96(3):190-5. doi: 10.1136/hrt.2009.180448. Epub 2009 Oct 26.

Abstract

OBJECTIVES

The aim of the study was to evaluate whether primary percutaneous coronary intervention (PCI) with combined proximal embolic protection and thrombus aspiration results in smaller final infarct size and improved left ventricular function assessed by cardiovascular magnetic resonance (CMR) in ST-segment elevation myocardial infarction (STEMI) patients compared with primary PCI alone. Background Primary PCI with the Proxis system improves immediate microvascular flow post-procedure as measured by ST-segment resolution, which could result in better outcomes.

METHODS

The ancillary CMR study included 206 STEMI patients who were enrolled in the PRoximal Embolic Protection in Acute myocardial infarction and Resolution of ST-Elevation (PREPARE) trial. CMR imaging was assessed between 4 and 6 months after the index procedure.

RESULTS

There were no significant differences in final infarct size (6.1 g/m(2) vs 6.3 g/m(2), p = 0.78) and left ventricular ejection fraction (50% vs 50%, p = 0.46) between both groups. Also, systolic wall thickening in the infarct area (44% vs 45%, p = 0.93) or the extent of transmural segments (8.3% of segments vs 8.3% of segments, p = 0.60) showed no significant differences. The incidence of major adverse cardiac and cerebral events at 6 months was similar in the Proxis and control group (8% vs 10%, respectively, p = 0.43). Conclusions Primary PCI with combined proximal embolic protection and thrombus aspiration in STEMI patients did not result in significant differences in final infarct size or left ventricular function at follow-up CMR. In addition, there was no difference in the incidence of major adverse cardiac and cerebral events at 6 months.

TRIAL REGISTRATION

number ISRCTN71104460.

摘要

目的

本研究旨在评估与单纯直接经皮冠状动脉介入治疗(PCI)相比,近端血栓保护装置联合血栓抽吸术在 ST 段抬高型心肌梗死(STEMI)患者中是否能使梗死面积更小,左心室功能改善,这种改善通过心血管磁共振(CMR)评估。背景:Proxis 系统辅助直接 PCI 可改善术后即刻微血管血流,通过 ST 段回落来评估,可能会带来更好的结果。

方法

该辅助 CMR 研究纳入了 206 名 STEMI 患者,他们参加了 Proximal Embolic Protection in Acute myocardial infarction and Resolution of ST-Elevation(PREPARE)试验。在指数手术后 4-6 个月进行 CMR 成像评估。

结果

两组患者最终梗死面积(6.1g/m²比 6.3g/m²,p=0.78)和左心室射血分数(50%比 50%,p=0.46)无显著差异。梗死区收缩期壁增厚(44%比 45%,p=0.93)或透壁节段范围(8.3%节段比 8.3%节段,p=0.60)也无显著差异。6 个月时,Proxis 组和对照组主要不良心脏和脑血管事件发生率相似(分别为 8%和 10%,p=0.43)。

结论

STEMI 患者直接 PCI 联合近端血栓保护装置和血栓抽吸术并不能使随访 CMR 检查的最终梗死面积或左心室功能产生显著差异。此外,6 个月时主要不良心脏和脑血管事件的发生率也无差异。

试验注册

ISRCTN71104460 号。

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