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急性 ST 段抬高型心肌梗死中采用 Minimalist 即刻机械干预方法行即刻与延迟支架置入的对比:MIMI 研究。

Comparison of Immediate With Delayed Stenting Using the Minimalist Immediate Mechanical Intervention Approach in Acute ST-Segment-Elevation Myocardial Infarction: The MIMI Study.

机构信息

From the Departments of Cardiology and Radiology, Centre Hospitalier Annecy-Genevois, Annecy, France (L. Belle, L.M., A.M.); Department of Cardiology, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France (P.M., G.S.); Department of Cardiology, Les Hôpitaux de Chartres, Eure-et-Loir, France (G.R.); Department of Cardiology, Centre Hospitalier de Vichy, Vichy, France (X.M., N.F.); Department of Cardiology, Centre Hospitalier St Luc St Joseph, Lyon, France (O.D.); Department of Cardiology, Centre Hospitalier de Cannes, Cannes, France (G.Z.); Department of Cardiology, Institut Mutualiste Monsouris, Paris, France (C.C., N.A.); Department of Cardiology, Hopital Nord, University hospital of Saint-Étienne, Saint-Étienne, France (K.I.); Department of Cardiology, Centre Hospitalier Universitaire de La Croix Rousse, Lyon, France (R.D.); Department of Cardiology, Clinique Saint Hilaire, Rouen, France (R.K.); Department of Cardiology, Clinique Convert, Bourg en Bresse, France (C.R.); Cardiovascular Institute, Groupe Hospitalier Mutualiste, Grenoble, France (B.F.); Department of Cardiology, Centre Hospitalier Universaitaire Marseille Nord, France (L. Bonello); Department of Cardiology, Hôpital de Valence, Valence, France (S.C.); Department of Cardiology, Hôpital Cardiologique, Lille university hospital, Lille, France (C.D.); Department of Cardiology, Hospital of Macon, Macon, France (F.C.); Department of Cardiology, Clinical Investigation Center, INSERM 1407, Hôpital Cardiovasculaire Louis Pradel, Lyon, France (N.M.); Clinical Investigation Centre, University Hospital of Grenoble, Grenoble, France (C.G., J.L.B.); and Department of Radiology, Hôpital Nord, University Hospital of Saint-Étienne, Saint-Étienne, France (M.V., P.C.).

出版信息

Circ Cardiovasc Interv. 2016 Mar;9(3):e003388. doi: 10.1161/CIRCINTERVENTIONS.115.003388.

DOI:10.1161/CIRCINTERVENTIONS.115.003388
PMID:26957418
Abstract

BACKGROUND

Delayed stent implantation after restoration of normal epicardial flow by a minimalist immediate mechanical intervention aims to decrease the rate of distal embolization and impaired myocardial reperfusion after percutaneous coronary intervention. We sought to confirm whether a delayed stenting (DS) approach (24-48 hours) improves myocardial reperfusion, versus immediate stenting, in patients with acute ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention.

METHODS AND RESULTS

In the prospective, randomized, open-label minimalist immediate mechanical intervention (MIMI) trial, patients (n=140) with ST-segment-elevation myocardial infarction ≤12 hours were randomized to immediate stenting (n=73) or DS (n=67) after Thrombolysis In Myocardial Infarction 3 flow restoration by thrombus aspiration. Patients in the DS group underwent a second coronary arteriography for stent implantation a median of 36 hours (interquartile range 29-46) after randomization. The primary end point was microvascular obstruction (% left ventricular mass) on cardiac magnetic resonance imaging performed 5 days (interquartile range 4-6) after the first procedure. There was a nonsignificant trend toward lower microvascular obstruction in the immediate stenting group compared with DS group (1.88% versus 3.96%; P=0.051), which became significant after adjustment for the area at risk (P=0.049). Median infarct weight, left ventricular ejection fraction, and infarct size did not differ between groups. No difference in 6-month outcomes was apparent for the rate of major cardiovascular and cerebral events.

CONCLUSIONS

The present findings do not support a strategy of DS versus immediate stenting in patients with ST-segment-elevation infarction undergoing primary percutaneous coronary intervention and even suggested a deleterious effect of DS on microvascular obstruction size.

CLINICAL TRIAL REGISTRATION

URL: http://www.clinicaltrials.gov. Unique identifier: NCT01360242.

摘要

背景

通过极简即刻机械干预恢复正常心外膜血流后延迟支架植入,旨在降低经皮冠状动脉介入治疗后远端栓塞和受损心肌再灌注的发生率。我们旨在确认在接受直接经皮冠状动脉介入治疗的急性 ST 段抬高型心肌梗死患者中,与即刻支架置入相比,延迟支架置入(DS)(24-48 小时)是否能改善心肌再灌注。

方法和结果

在前瞻性、随机、开放标签极简即刻机械干预(MIMI)试验中,140 名 ST 段抬高型心肌梗死患者(发病时间≤12 小时)随机分为即刻支架置入组(n=73)和 DS 组(n=67),两组患者在血栓抽吸后溶栓治疗 3 达到血流恢复后立即进行支架置入。DS 组患者在随机分组后中位 36 小时(四分位距 29-46)进行第二次冠状动脉造影以植入支架。主要终点是首次治疗后 5 天(四分位距 4-6)行心脏磁共振成像检查的微血运阻塞(左心室质量的%)。即刻支架置入组的微血运阻塞率较 DS 组有降低的趋势(1.88% vs. 3.96%;P=0.051),但在调整危险面积后无统计学意义(P=0.049)。两组间梗死重量、左心室射血分数和梗死面积无差异。主要心血管和脑事件发生率两组间无差异。

结论

目前的研究结果不支持在接受直接经皮冠状动脉介入治疗的 ST 段抬高型心肌梗死患者中采用 DS 策略与即刻支架置入相比的策略,甚至提示 DS 对微血运阻塞程度有不良影响。

临床试验注册

网址:http://www.clinicaltrials.gov。唯一识别码:NCT01360242。

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