磺达肝癸钠联合盐酸替罗非班在接受复杂经皮冠状动脉介入治疗的急性冠状动脉综合征患者中的临床疗效及安全性

[The clinical efficacy and safety of fondaparinux combined with tirofiban hydrochloride in patients with acute coronary syndrome undergoing complex percutaneous coronary intervention].

作者信息

Li Mu-wei, Zhao Xiang-mei, Rao Li-xin, Chen Yan, Zhu Zhong-yu, Gao Chuan-yu

机构信息

Department of Cardiology, Henan Provincial People's Hospital,Zhengzhou 450003, China. Email:

出版信息

Zhonghua Nei Ke Za Zhi. 2013 Dec;52(12):1037-40.

PMID:24503402

Abstract

OBJECTIVE

To explore the efficacy and safety of fondaparinux combined with tirofiban in patients with high risk unstable angina (UA) undergoing complex percutaneous coronary intervention (PCI) .

METHODS

A total of 389 patients were enrolled and randomized into two groups receiving either fondaparinux with tirofiban or enoxaparin with tirofiban. Bleeding, thrombosis and main adverse cardiovascular events (MACE) were compared between the two groups during hospitalization, at week 2 and week 4 after discharge.

RESULTS

No severe bleeding was observed during hospitalization in the both groups, while lower rate of mild and minor bleeding was shown in the fondaparinux group (0 vs 1.5% and 18.2% vs 34.5%, P = 0.04 and P < 0.001 respectively). No difference was found between the two groups in the rate of MACE during hospitalization, at week 2 and week 4 weeks after discharge. The rates of death, recurrent myocardial infarction, refractory myocardial ischemia and target vessel revascularization were 0.5% vs 1.0%, 0.5% vs 1.0%, 1.6% vs 1.0% and 2.1% vs 1.5% during hospitalization; 0 vs 0, 1.0% vs 0.5%, 1.0% vs 1.5%, 0.5% vs 1.0% at week 2 after discharge; 0.5% vs 0.5%, 0.5% vs 0.5%, 2.6% vs 2.0%, 0 vs 0.5% at week 4 after discharge (all P values>0.05).

CONCLUSION

The combination therapy of fondaparinux and tirofiban is of good safety and efficacy in high risk UA patients undergoing complex PCI.

摘要

目的

探讨磺达肝癸钠联合替罗非班在接受复杂经皮冠状动脉介入治疗（PCI）的高危不稳定型心绞痛（UA）患者中的疗效和安全性。

方法

共纳入389例患者，随机分为两组，分别接受磺达肝癸钠联合替罗非班或依诺肝素联合替罗非班治疗。比较两组患者住院期间、出院后第2周和第4周的出血、血栓形成及主要不良心血管事件（MACE）情况。

结果

两组患者住院期间均未观察到严重出血，而磺达肝癸钠组轻度和轻微出血发生率较低（分别为0 vs 1.5%和18.2% vs 34.5%，P = 0.04和P < 0.001）。两组患者住院期间、出院后第2周和第4周的MACE发生率无差异。住院期间死亡、再发心肌梗死、难治性心肌缺血及靶血管血运重建率分别为0.5% vs 1.0%、0.5% vs 1.0%、1.6% vs 1.0%和2.1% vs 1.5%；出院后第2周分别为0 vs 0、1.0% vs 0.5%、1.0% vs 1.5%、0.5% vs 1.0%；出院后第4周分别为0.5% vs 0.5%、0.5% vs 0.5%、2.6% vs 2.0%、0 vs 0.5%（所有P值>0.05）。