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与静脉内阿昔单抗相比,经皮冠状动脉介入治疗 ST 段抬高型心肌梗死患者的冠状动脉内给药的获益:8 项随机试验的荟萃分析。

Benefits from intracoronary as compared to intravenous abciximab administration for STEMI patients undergoing primary angioplasty: a meta-analysis of 8 randomized trials.

机构信息

Division of Cardiology, Maggiore della Carità Hospital, Università del Piemonte Orientale, Novara, Italy.

出版信息

Atherosclerosis. 2012 Jun;222(2):426-33. doi: 10.1016/j.atherosclerosis.2012.02.041. Epub 2012 Mar 7.

Abstract

BACKGROUND

Adjunctive abciximab administration has been demonstrated to reduce mortality and reinfarction in patients with ST-elevation myocardial infarction (STEMI) referred to invasive management. Standard abciximab regimen consists of an intravenous (IV) bolus followed by a 12-h IV infusion. Experimental studies and small clinical trials suggest the superiority of intracoronary (IC) injection of abciximab over IV route. Therefore, the aim of the current study was to perform a meta-analysis of randomized trials (RCTs) to assess the clinical efficacy and safety of IC vs IV abciximab administration in STEMI patients undergoing primary angioplasty.

METHODS

We obtained results from all RCTs enrolling STEMI patients undergoing primary percutaneous coronary intervention (PCI). The primary endpoint was mortality, while recurrent myocardial infarction, postprocedural epicardial (TIMI 3) and myocardial (MBG 2-3) perfusion were identified as secondary endpoints. The safety endpoint was the risk of major bleeding complications.

RESULTS

A total of 8 randomized trials were finally included in the meta-analysis, enrolling a total of 3259 patients. As compared to IV route, IC abciximab was associated with a significant improvement in myocardial perfusion (OR [95% CI]=1.76 [1.28-2.42], p<0.001), without significant benefits in terms of mortality (OR [95% CI]=0.85 [0.59-1.23], p=0.39), reinfarction (OR [95% CI]=0.79 [0.46-1.33], p=0.37), or major bleeding complications (OR [95% CI]=1.19 [0.76-1.87], p=0.44). However, we observed a significant relationship between patient's risk profile and mortality benefits from IC abciximab administration (p=0.011).

CONCLUSIONS

The present updated meta-analysis showed that IC administration of abciximab is associated with significant benefits in myocardial perfusion, but not in clinical outcome at short-term follow-up as compared to IV abciximab administration, without any excess of major bleedings in STEMI patients undergoing primary PCI. However, a significant relationship was observed between patient's risk profile and mortality benefits from IC abciximab administration. Therefore, waiting for long-term follow-up results and additional randomized trials, IC abciximab administration cannot be routinely recommended, but may be considered in high-risk patients.

摘要

背景

在接受介入治疗的 ST 段抬高型心肌梗死(STEMI)患者中,辅助应用阿昔单抗可降低死亡率和再梗死率。标准阿昔单抗方案包括静脉内(IV)推注,随后进行 12 小时 IV 输注。实验研究和小型临床试验表明,冠状动脉内(IC)注射阿昔单抗优于 IV 途径。因此,本研究的目的是对随机试验(RCT)进行荟萃分析,以评估在接受直接经皮冠状动脉介入治疗(PCI)的 STEMI 患者中,IC 与 IV 阿昔单抗给药的临床疗效和安全性。

方法

我们从所有纳入 STEMI 患者接受直接经皮冠状动脉介入治疗(PCI)的 RCT 中获得结果。主要终点是死亡率,而复发性心肌梗死、经皮冠状动脉介入治疗后的心外膜(TIMI 3)和心肌(MBG 2-3)灌注则作为次要终点。安全性终点是大出血并发症的风险。

结果

最终共有 8 项 RCT 纳入荟萃分析,共纳入 3259 例患者。与 IV 途径相比,IC 阿昔单抗可显著改善心肌灌注(OR [95%CI]=1.76 [1.28-2.42],p<0.001),但在死亡率(OR [95%CI]=0.85 [0.59-1.23],p=0.39)、再梗死(OR [95%CI]=0.79 [0.46-1.33],p=0.37)或大出血并发症(OR [95%CI]=1.19 [0.76-1.87],p=0.44)方面无显著获益。然而,我们观察到患者风险特征与 IC 阿昔单抗给药的死亡率获益之间存在显著关系(p=0.011)。

结论

本更新的荟萃分析显示,与 IV 阿昔单抗给药相比,IC 给予阿昔单抗可显著改善心肌灌注,但在短期随访时对临床结局无影响,在接受直接 PCI 的 STEMI 患者中没有增加大出血的风险。然而,我们观察到患者风险特征与 IC 阿昔单抗给药的死亡率获益之间存在显著关系。因此,在等待长期随访结果和额外的随机试验之前,不能常规推荐 IC 阿昔单抗给药,但可能会考虑在高危患者中使用。

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