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经皮冠状动脉介入治疗联合血栓抽吸术治疗 ST 段抬高型心肌梗死患者中冠状动脉内与静脉内应用阿昔单抗的比较:ST 段抬高型心肌梗死紧急再灌注时冠状动脉内与静脉内应用阿昔单抗的比较(CICERO)试验。

Intracoronary versus intravenous administration of abciximab in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention with thrombus aspiration: the comparison of intracoronary versus intravenous abciximab administration during emergency reperfusion of ST-segment elevation myocardial infarction (CICERO) trial.

机构信息

Department of Cardiology, Thorax Center, University Medical Center Groningen, University of Groningen, Hanzeplein 1, PO Box 30001 9700 RB Groningen, Netherlands.

出版信息

Circulation. 2010 Dec 21;122(25):2709-17. doi: 10.1161/CIRCULATIONAHA.110.002741. Epub 2010 Nov 15.

Abstract

BACKGROUND

administration of the glycoprotein IIb/IIIa inhibitor abciximab is an effective adjunctive treatment strategy during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction. Although small-scale studies have suggested beneficial effects of intracoronary over intravenous administration of abciximab, this has not been investigated in a medium-scale randomized clinical trial.

METHODS AND RESULTS

a total of 534 ST-segment elevation myocardial infarction patients undergoing primary percutaneous coronary intervention with thrombus aspiration within 12 hours of symptom onset were randomized to either an intracoronary or an intravenous bolus of abciximab (0.25 mg/kg). Patients were pretreated with aspirin, heparin, and clopidogrel. The primary end point was the incidence of restored myocardial reperfusion, defined as complete ST-segment resolution. Secondary end points included myocardial reperfusion as assessed by myocardial blush grade, enzymatic infarct size, and major adverse cardiac events at 30 days. The incidence of complete ST-segment resolution was similar in the intracoronary and intravenous groups (64% versus 62%; P=0.562). However, the incidence of myocardial blush grade 2/3 was higher in the intracoronary group than in the intravenous group (76% versus 67%; P=0.022). Furthermore, enzymatic infarct size was smaller in the intracoronary than in the intravenous group (P=0.008). The incidence of major adverse cardiac events was similar in both groups (5.5% versus 6.1%; P=0.786).

CONCLUSIONS

in ST-segment elevation myocardial infarction patients undergoing primary percutaneous coronary intervention with thrombus aspiration, intracoronary administration of abciximab compared with intravenous administration does not improve myocardial reperfusion as assessed by ST-segment resolution. However, intracoronary administration is associated with improved myocardial reperfusion as assessed by myocardial blush grade and a smaller enzymatic infarct size.

摘要

背景

在 ST 段抬高型心肌梗死患者行直接经皮冠状动脉介入治疗时,给予糖蛋白Ⅱb/Ⅲa 抑制剂阿昔单抗治疗可作为一种有效的辅助治疗策略。虽然小规模研究提示冠状动脉内给予比静脉内给予阿昔单抗有更好的效果,但这尚未在中等规模的随机临床试验中得到验证。

方法和结果

共纳入 534 例在症状发作 12 小时内行直接经皮冠状动脉介入治疗且接受血栓抽吸术的 ST 段抬高型心肌梗死患者,随机分为冠状动脉内或静脉内给予阿昔单抗(0.25 mg/kg)。患者均接受阿司匹林、肝素和氯吡格雷预处理。主要终点是恢复心肌再灌注的发生率,定义为完全 ST 段回落。次要终点包括心肌再灌注的评估指标,包括心肌染色分级、酶学梗死面积和 30 天内的主要不良心脏事件。冠状动脉内组和静脉内组完全 ST 段回落的发生率相似(64%比 62%;P=0.562)。然而,冠状动脉内组心肌染色分级 2/3 的发生率高于静脉内组(76%比 67%;P=0.022)。此外,冠状动脉内组的酶学梗死面积小于静脉内组(P=0.008)。两组的主要不良心脏事件发生率相似(5.5%比 6.1%;P=0.786)。

结论

在接受血栓抽吸术的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,与静脉内给予阿昔单抗相比,冠状动脉内给予阿昔单抗并未改善 ST 段回落评估的心肌再灌注。然而,冠状动脉内给予阿昔单抗与更好的心肌再灌注相关,表现为心肌染色分级改善和酶学梗死面积减小。

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