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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冠状动脉内注射与静脉推注阿昔单抗的比较:随机化的莱比锡直接经皮冠状动脉介入治疗ST段抬高型心肌梗死阿昔单抗静脉注射与冠状动脉内注射试验

Intracoronary compared with intravenous bolus abciximab application in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: the randomized Leipzig immediate percutaneous coronary intervention abciximab IV versus IC in ST-elevation myocardial infarction trial.

作者信息

Thiele Holger, Schindler Kathrin, Friedenberger Josef, Eitel Ingo, Fürnau Georg, Grebe Eigk, Erbs Sandra, Linke Axel, Möbius-Winkler Sven, Kivelitz Dietmar, Schuler Gerhard

机构信息

Department of Internal Medicine/Cardiology, University of Leipzig, Heart Center, Strümpellstrasse 39, 04289 Leipzig, Germany.

出版信息

Circulation. 2008 Jul 1;118(1):49-57. doi: 10.1161/CIRCULATIONAHA.107.747642. Epub 2008 Jun 16.

DOI:10.1161/CIRCULATIONAHA.107.747642
PMID:18559698
Abstract

BACKGROUND

Abciximab reduces major adverse cardiac events in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention (PCI). Intracoronary abciximab bolus application results in high local drug concentrations and may be more effective than a standard intravenous bolus.

METHODS AND RESULTS

Patients undergoing primary PCI were randomized to either intracoronary (n=77) or intravenous (n=77) bolus abciximab administration with subsequent 12-hour intravenous infusion. The primary end point was infarct size and extent of microvascular obstruction as assessed by delayed enhancement magnetic resonance. Secondary end points were ST-segment resolution at 90 minutes, Thrombolysis in Myocardial Infarction flow and perfusion grades after PCI, and the occurrence of major adverse cardiac events within 30 days. The median infarct size was 15.1% (interquartile range, 6.1% to 25.2%) in the intracoronary versus 23.4% (interquartile range, 13.6% to 33.2%) in the intravenous group (P=0.01). Similarly, the extent of microvascular obstruction was significantly smaller in intracoronary compared with intravenous abciximab patients (P=0.01). Myocardial perfusion measured as early ST-segment resolution was significantly improved in intracoronary patients with an absolute ST-segment resolution of 77.8% (interquartile range, 66.7% to 100.0%) versus 70.0% (interquartile range, 45.2% to 83.5%; P=0.006). The Thrombolysis in Myocardial Infarction flow after PCI was not different between treatment groups (P=0.51), but there was a trend toward an improved perfusion grade (P=0.09). There also was a trend toward a lower major adverse cardiac event rate after intracoronary versus intravenous abciximab application (5.2% versus 15.6%; P=0.06; relative risk, 0.33; 95% CI, 0.09 to 1.05).

CONCLUSIONS

Intracoronary bolus administration of abciximab in primary PCI is superior to standard intravenous treatment with respect to infarct size, extent of microvascular obstruction, and perfusion.

摘要

背景

阿昔单抗可降低接受直接经皮冠状动脉介入治疗(PCI)的ST段抬高型心肌梗死患者的主要不良心脏事件。冠状动脉内推注阿昔单抗可导致局部药物浓度升高,可能比标准静脉推注更有效。

方法与结果

接受直接PCI的患者被随机分为冠状动脉内(n = 77)或静脉内(n = 77)推注阿昔单抗,随后进行12小时静脉输注。主要终点是通过延迟强化磁共振评估的梗死面积和微血管阻塞程度。次要终点是90分钟时ST段分辨率、PCI后心肌梗死溶栓血流和灌注分级,以及30天内主要不良心脏事件的发生情况。冠状动脉内组的梗死面积中位数为15.1%(四分位间距,6.1%至25.2%),而静脉内组为23.4%(四分位间距,13.6%至33.2%)(P = 0.01)。同样,与静脉内阿昔单抗治疗的患者相比,冠状动脉内阿昔单抗治疗患者的微血管阻塞程度明显更小(P = 0.01)。以早期ST段分辨率衡量的心肌灌注在冠状动脉内给药的患者中显著改善,绝对ST段分辨率为77.8%(四分位间距,66.7%至100.0%),而静脉内给药组为70.0%(四分位间距,45.2%至83.5%;P = 0.006)。PCI后心肌梗死溶栓血流在治疗组之间无差异(P = 0.51),但灌注分级有改善趋势(P = 0.09)。冠状动脉内与静脉内应用阿昔单抗后主要不良心脏事件发生率也有降低趋势(5.2%对15.6%;P = 0.06;相对风险,0.33;95%CI,0.09至1.05)。

结论

在直接PCI中,冠状动脉内推注阿昔单抗在梗死面积、微血管阻塞程度和灌注方面优于标准静脉治疗。

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