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ST段抬高型心肌梗死患者再灌注前冠状动脉内注射腺苷:一项随机对照临床试验。

Intracoronary injection of adenosine before reperfusion in patients with ST-segment elevation myocardial infarction: a randomized controlled clinical trial.

作者信息

Garcia-Dorado David, García-del-Blanco Bruno, Otaegui Imanol, Rodríguez-Palomares José, Pineda Victor, Gimeno Federico, Ruiz-Salmerón Rafael, Elizaga Jaime, Evangelista Arturo, Fernandez-Avilés Francisco, San-Román Alberto, Ferreira-González Ignacio

机构信息

Cardiology Department, Vall d'Hebron Hospital, Universitat Autónoma de Barcelona, Barcelona, Spain.

Cardiology Department, Vall d'Hebron Hospital, Universitat Autónoma de Barcelona, Barcelona, Spain.

出版信息

Int J Cardiol. 2014 Dec 20;177(3):935-41. doi: 10.1016/j.ijcard.2014.09.203. Epub 2014 Oct 7.

Abstract

BACKGROUND

The effect of intracoronary adenosine (ADO) on ST-segment elevation myocardial infarction (STEMI) size and adverse remodeling is not well established.

METHODS

In a double-blind trial, 201 patients with STEMI were randomized to receive percutaneous coronary intervention (PCI) within 6 hours of symptom onset, 4.5mg ADO or saline immediately prior to reperfusion. Primary end-point: percentage of total myocardial necrotic mass by cardiac magnetic resonance (CMR) 2-7 days post-reperfusion. Secondary end-points: changes in left ventricular volumes and ejection fraction (LVEF) at baseline and at 6 months.

RESULTS

Baseline CMR could not be performed in 20 patients. Overall, no significant differences were observed between ADO and placebo regarding infarct size (20.8% vs. 22.5%; p=0.40). However, infarct size was significantly reduced (19.4% vs. 25.7%; p for interaction=0.031) in those with ischemia duration below the median (200 min). CMR at 6 months, performed in 138 patients, did not show statistically significant differences between groups in the rate of LVEF increase (3.3 units (SD 9.6) in ADO group vs. 1.5 units (SD 9) in placebo group; p=0.25). In the subgroup analysis, among patients with ischemia time below 200 min, the increase in LVEF was slightly higher with ADO (3.59% vs. 0.43%; p for interaction=0.06).

CONCLUSIONS

Although our study failed to demonstrate that intracoronary administration of ADO prior to PCI limits infarct size, in patients receiving early PCI ADO might enhance myocardial salvage and has a favorable effect on LVEF evolution, which may help to reconcile apparently contradictory results of previous studies.

CLINICAL TRIAL REGISTRATION

http://clinicaltrials.gov (NCT00781404).

摘要

背景

冠状动脉内注射腺苷(ADO)对ST段抬高型心肌梗死(STEMI)面积及不良重构的影响尚未明确。

方法

在一项双盲试验中,201例STEMI患者在症状发作6小时内随机接受经皮冠状动脉介入治疗(PCI),在再灌注前即刻给予4.5mg ADO或生理盐水。主要终点:再灌注后2 - 7天通过心脏磁共振成像(CMR)测定的心肌坏死总量百分比。次要终点:基线及6个月时左心室容积和射血分数(LVEF)的变化。

结果

20例患者无法进行基线CMR检查。总体而言,ADO组与安慰剂组在梗死面积方面无显著差异(20.8%对22.5%;p = 0.40)。然而,在缺血持续时间低于中位数(200分钟)的患者中,梗死面积显著减小(19.4%对25.7%;交互作用p = 0.031)。138例患者在6个月时进行的CMR检查显示,两组间LVEF增加率无统计学显著差异(ADO组为3.3个单位(标准差9.6),安慰剂组为1.5个单位(标准差9);p = 0.25)。在亚组分析中,缺血时间低于200分钟的患者中,ADO组LVEF的增加略高(3.59%对0.43%;交互作用p = 0.06)。

结论

尽管我们的研究未能证明PCI前冠状动脉内注射ADO可限制梗死面积,但在接受早期PCI的患者中,ADO可能增强心肌挽救,并对LVEF演变有有利影响,这可能有助于调和先前研究中明显矛盾的结果。

临床试验注册

http://clinicaltrials.gov(NCT00781404)

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