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经溶栓治疗失败后行经桡动脉补救性经皮冠状动脉介入治疗的 ST 段抬高型心肌梗死患者中比较冠状动脉内与静脉内阿昔单抗的随机双盲安慰剂对照研究

A Randomized Double-Blind Placebo-Controlled Study Comparing Intracoronary Versus Intravenous Abciximab in Patients With ST-Elevation Myocardial Infarction Undergoing Transradial Rescue Percutaneous Coronary Intervention After Failed Thrombolysis.

机构信息

Quebec Heart-Lung Institute, Quebec, Canada.

Quebec Heart-Lung Institute, Quebec, Canada.

出版信息

Am J Cardiol. 2018 Jul 1;122(1):47-53. doi: 10.1016/j.amjcard.2018.03.007. Epub 2018 Mar 28.

Abstract

The risk and benefit ratio of glycoprotein IIb/IIIa inhibitors with dual oral antiplatelet therapy after failed thrombolysis and rescue percutaneous coronary intervention (PCI) is unclear. Using a randomized placebo-controlled, double-blind design, we compared intravenous (IV) and intracoronary (IC) abciximab delivery in 74 patients referred for rescue transradial PCI. The primary angiographic end points were the final thrombolysis in myocardial infarction flow and myocardial blush grades. Secondary end points included acute and 6-month outcomes using angiographic parameters, platelet aggregation parameters, cardiac biomarkers, cardiac magnetic resonance measurements (CMR) and clinical end points. After rescue PCI, normal thrombolysis in myocardial infarction 3 flows were obtained in 70% in the IC group, 48% in the IV group, and 71% in the placebo group, respectively (p = 0.056). Final myocardial blush grades 2 and 3 were obtained in 43% and 39% in the IC group, 48% and 26% in the IV group, and 46% and 42% in the placebo group (p = 0.67), respectively. Acutely, peak release of cardiac biomarkers, necrosis size, myocardial perfusion and no-reflow as assessed by CMR, and clinical end points were similar between the groups and did not suggest a benefit for IC or IV abciximab compared with placebo. There was no increase in bleeding or access site-related complications with abciximab compared with placebo. Clinical, angiographic, and CMR outcomes at 6 months remained comparable between the groups. In patients with ST-elevation myocardial infarction presenting with failed thrombolysis undergoing transradial rescue PCI, IC or IV abciximab had no significant clinical impact.

摘要

经溶栓治疗失败和挽救性经皮冠状动脉介入治疗(PCI)后,糖蛋白 IIb/IIIa 抑制剂与双联口服抗血小板治疗的风险效益比尚不清楚。我们采用随机安慰剂对照、双盲设计,比较了 74 例因挽救性经桡动脉 PCI 而转介的患者静脉(IV)和冠状动脉内(IC)给予阿昔单抗的效果。主要血管造影终点是最终心肌梗死溶栓血流和心肌灌注分级。次要终点包括血管造影参数、血小板聚集参数、心脏标志物、心脏磁共振测量(CMR)和临床终点的急性和 6 个月结果。挽救性 PCI 后,IC 组 70%、IV 组 48%和安慰剂组 71%的患者获得正常的心肌梗死溶栓血流 3 级,组间差异无统计学意义(p=0.056)。IC 组最终心肌灌注分级 2 级和 3 级分别为 43%和 39%,IV 组分别为 48%和 26%,安慰剂组分别为 46%和 42%,组间差异无统计学意义(p=0.67)。各组间急性时心脏标志物峰值释放、坏死面积、心肌灌注和 CMR 评估的无复流以及临床终点均相似,这表明与安慰剂相比,IC 或 IV 阿昔单抗并没有带来获益。与安慰剂相比,阿昔单抗并未增加出血或与入路相关的并发症。6 个月时的临床、血管造影和 CMR 结果在各组间仍具有可比性。在 ST 段抬高型心肌梗死患者中,经溶栓治疗失败而行经桡动脉挽救性 PCI 时,IC 或 IV 阿昔单抗并无显著临床影响。

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