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急性 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,冠状动脉内与静脉内推注阿昔单抗比较:可降低 30 天死亡率和靶血管血运重建:一项随机试验。

Intracoronary compared to intravenous bolus abciximab during primary percutaneous coronary intervention in ST-segment Elevation Myocardial Infarction (STEMI) patients reduces 30-day mortality and target vessel revascularization: a randomized trial.

机构信息

Department of Cardiology, Gentofte University Hospital, Copenhagen, Denmark.

出版信息

J Interv Cardiol. 2011 Apr;24(2):105-11. doi: 10.1111/j.1540-8183.2010.00616.x. Epub 2010 Dec 22.

Abstract

BACKGROUND

Abciximab is beneficial in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI). However, the optimal administration route of the initial bolus of abciximab, that is, intravenous (IV) versus intracoronary (IC), has been questioned. Preliminary studies suggest that IC-bolus is superior, probably due to high local concentration. In this study, we assess the short-term efficacy and safety of IC compared to IV bolus of abciximab in patients with STEMI during pPCI.

METHODS

In 2006-2008, we randomized 355 STEMI patients who underwent pPCI and had indication for abciximab to either IV or IC bolus followed by a 12-hour IV infusion. Primary end-points at 30 days were target vessel revascularization (TVR), recurrent myocardial infarction (MI) or death, and the composite of the three. Secondary end-points were bleeding complications.

RESULTS

The two groups (IV n = 170;IC n = 185) were similar with respect to baseline characteristics. Mortality at 30 days was 5.3% in the IV group compared to only 1.1% in the IC group (P = 0.02). TVR was performed in 9.4% in the IV group compared to 3.8% in the IC group (P = 0.03). No significant difference in MI rates was seen (IV 4.7% vs. IC 2.7%; P = 0.32). We found a significant reduction in the composite end-point (IV 19.4% vs. IC 7.6%; P = 0.001) in favor of IC use. Major bleeding complications were similar (IV 2.4% vs. IC 1.6%; P = 0.62). Neither difference was observed in minor bleedings (IV 14.1% vs. IC 9.7%; P = 0.20).

CONCLUSION

IC administration of bolus abciximab in STEMI patients undergoing pPCI reduces 30-day mortality and TVR and tends to reduce MI, compared to IV-bolus.

摘要

背景

替罗非班在接受直接经皮冠状动脉介入治疗(pPCI)的 ST 段抬高型心肌梗死(STEMI)患者中是有益的。然而,替罗非班初始推注的最佳给药途径,即静脉内(IV)与冠状动脉内(IC),一直存在争议。初步研究表明,IC 推注优于 IV 推注,可能是由于局部浓度高。在这项研究中,我们评估了在 pPCI 期间 STEMI 患者中与 IV 推注相比,IC 推注替罗非班的短期疗效和安全性。

方法

在 2006 年至 2008 年,我们将 355 例接受 pPCI 且有替罗非班适应证的 STEMI 患者随机分为 IV 或 IC 推注组,随后进行 12 小时的 IV 输注。30 天的主要终点是靶血管血运重建(TVR)、复发性心肌梗死(MI)或死亡,以及三者的复合终点。次要终点是出血并发症。

结果

两组(IV 组 n = 170;IC 组 n = 185)在基线特征方面相似。IV 组 30 天死亡率为 5.3%,而 IC 组仅为 1.1%(P = 0.02)。IV 组 TVR 率为 9.4%,而 IC 组为 3.8%(P = 0.03)。MI 发生率无显著差异(IV 组 4.7% vs. IC 组 2.7%;P = 0.32)。我们发现复合终点(IV 组 19.4% vs. IC 组 7.6%;P = 0.001)显著降低,有利于 IC 应用。主要出血并发症相似(IV 组 2.4% vs. IC 组 1.6%;P = 0.62)。轻微出血也没有差异(IV 组 14.1% vs. IC 组 9.7%;P = 0.20)。

结论

与 IV 推注相比,在接受 pPCI 的 STEMI 患者中,IC 推注替罗非班可降低 30 天死亡率和 TVR,并降低 MI 发生率。

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