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依替巴肽或替罗非班用于择期经皮冠状动脉介入治疗时依诺肝素与肝素的比较(ACTION试验)

Comparison of enoxaparin versus heparin during elective percutaneous coronary intervention performed with either eptifibatide or tirofiban (the ACTION Trial).

作者信息

Madan Mina, Radhakrishnan Shyam, Reis Marciano, Paradiso-Hardy Fran L, Godin-Edgecombe Maggie, Sparling Catherine, Phillips Anne Marie, Shanmugasegaram Shamila, Fort Stephen, Naqvi Salim Z, Cohen Eric A

机构信息

Schulich Heart Centre, Sunnybrook & Women's College Health Sciences Centre, Toronto, Ontario, Canada.

出版信息

Am J Cardiol. 2005 Jun 1;95(11):1295-301. doi: 10.1016/j.amjcard.2005.01.071.

Abstract

Limited data are available with regard to the pharmacodynamics and safety of combining enoxaparin with glycoprotein IIb/IIIa inhibition during elective percutaneous coronary interventions (PCIs). We randomized 200 patients to receive open-label enoxaparin (0.75 mg/kg intravenous bolus) or unfractionated heparin (60 U/kg intravenous bolus) and eptifibatide or tirofiban during PCI. This yielded 4 groups of combination therapy (50 patients/group). The first 10 patients per group had anti-Xa activity and inhibition of platelet aggregation measured at baseline, and at 5 minutes, 10 minutes, 4 hours, and 24 hours. All patients received aspirin and clopidogrel therapy before PCI. Patients who received enoxaparin and heparin achieved therapeutic peak anti-Xa activity observed shortly after drug administration. At 4 hours, a differential anticoagulant effect was observed, with patients who received enoxaparin having a more gradual decrease in anti-Xa activity. Patients who received eptifibatide achieved >80% inhibition of platelet aggregation soon after initiation of therapy more often than did those who received tirofiban. Type of heparin did not affect inhibition of platelet aggregation. Compared with patients who received heparin, periprocedural myocardial infarction and bleeding events occurred less frequently among those who received enoxaparin (14% vs 8% and 10% vs 5%); however, these differences were not statistically significant. Three cases of intraprocedural thrombus occurred among patients who received enoxaparin. Two patients received concomitant tirofiban therapy. Compared with unfractionated heparin, similar levels of anticoagulation and platelet inhibition are achieved with enoxaparin when concomitant therapy with eptifibatide or tirofiban is used during elective PCI, without an observed increase in early bleeding events or periprocedural ischemic complications.

摘要

关于在择期经皮冠状动脉介入治疗(PCI)期间联合使用依诺肝素与糖蛋白IIb/IIIa抑制剂的药效学和安全性,可用数据有限。我们将200例患者随机分为两组,一组接受开放标签的依诺肝素(0.75mg/kg静脉推注),另一组接受普通肝素(60U/kg静脉推注),并在PCI期间使用依替巴肽或替罗非班。这产生了4组联合治疗方案(每组50例患者)。每组的前10例患者在基线、5分钟、10分钟、4小时和24小时测量抗Xa活性和血小板聚集抑制情况。所有患者在PCI前均接受阿司匹林和氯吡格雷治疗。接受依诺肝素和肝素的患者在给药后不久达到治疗性抗Xa活性峰值。在4小时时,观察到一种差异性抗凝作用,接受依诺肝素的患者抗Xa活性下降更为缓慢。接受依替巴肽的患者在治疗开始后不久比接受替罗非班的患者更常实现>80%的血小板聚集抑制。肝素类型不影响血小板聚集抑制。与接受肝素的患者相比,接受依诺肝素的患者围手术期心肌梗死和出血事件发生率较低(分别为14%对8%和10%对5%);然而,这些差异无统计学意义。接受依诺肝素的患者中有3例发生术中血栓。2例患者同时接受替罗非班治疗。与普通肝素相比,在择期PCI期间联合使用依替巴肽或替罗非班时,依诺肝素可实现相似水平的抗凝和血小板抑制,且未观察到早期出血事件或围手术期缺血并发症增加。

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