首页> 外文期刊>The American heart journal >Intracoronary compared with intravenous bolus abciximab application during primary percutaneous coronary intervention: design and rationale of the Abciximab Intracoronary versus intravenously Drug Application in ST-Elevation Myocardial Infarction (AIDA STEMI) trial.
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Intracoronary compared with intravenous bolus abciximab application during primary percutaneous coronary intervention: design and rationale of the Abciximab Intracoronary versus intravenously Drug Application in ST-Elevation Myocardial Infarction (AIDA STEMI) trial.

机译:在原发性经皮冠状动脉介入治疗中与冠脉内注射与静脉推注abciximab的应用比较:在ST抬高型心肌梗死(AIDA STEMI)试验中,阿昔单抗冠脉内与静脉内药物应用的设计和原理。

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BACKGROUND: Intravenous abciximab reduces major adverse cardiac events in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Intracoronary abciximab bolus application during PCI results in high local drug concentration, improved perfusion, reduction of infarct size, and less microvascular obstruction. The hypothesis of this trial is that abciximab bolus intracoronary in comparison to standard intravenous application will improve the outcome of patients undergoing primary PCI in STEMI. STUDY DESIGN: The Abciximab Intracoronary versus intravenously Drug Application in STEMI (AIDA STEMI) study is a 1,912-patient, prospective, multicenter, randomized, open-label, controlled trial. The study is designed to compare the efficacy and safety of intracoronary versus intravenous bolus abciximab administration during primary PCI with subsequent intravenous infusion for 12 hours. Patients will be randomized in a 1:1 fashion to 1 of the 2 treatments. The primary efficacy end point of AIDA STEMI is the composite of all-cause mortality, recurrent MI, or new congestive heart failure within 90 days of randomization. The primary safety outcome assessment will be major bleeding. CONCLUSIONS: The AIDA STEMI study addresses important questions regarding the efficacy and safety of intracoronary abciximab bolus administration during primary PCI in patients with STEMI, potentially optimizing the route of administration of glycoprotein IIb/IIIa inhibitors in the catheterization laboratory.
机译:背景:静脉abciximab减少了接受原发性经皮冠状动脉介入治疗(PCI)的ST抬高型心肌梗死(STEMI)患者的主要不良心脏事件。 PCI期间应用冠状动脉内阿昔单抗推注可导致局部药物浓度高,灌注改善,梗塞面积减少和微血管阻塞减少。该试验的假设是与标准静脉内应用相比,阿昔单抗冠状动脉内推注将改善接受STEMI初次PCI的患者的预后。研究设计:阿昔单抗在STEMI(AIDA STEMI)中的冠脉内和静脉药物应用研究是一项对1,912名患者的前瞻性,多中心,随机,开放标签,对照试验。这项研究旨在比较在初次PCI与随后静脉输注12小时期间冠脉内与静脉推注阿昔单抗的疗效和安全性。患者将以1:1的方式随机分配到两种治疗方法中的一种。 AIDA STEMI的主要疗效终点是随机化后90天内全因死亡率,复发性MI或新发充血性心力衰竭的综合结果。主要安全性结果评估为大出血。结论:AIDA STEMI研究解决了关于STEMI患者初次PCI期间冠脉内abciximab推注给药的有效性和安全性的重要问题,可能在导管实验室优化糖蛋白IIb / IIIa抑制剂的给药途径。

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