替罗非班用于中高危非ST段抬高型急性冠状动脉综合征患者经皮冠状动脉介入治疗成功后的疗效及安全性

[Efficacy and safety of tirofiban use after successful percutaneous coronary intervention for patients with moderate to high risk non-ST segment elevation acute coronary syndromes].

作者信息

Zhang You, Gao Chuan-yu, Zhu Zhong-yu, Liu Hong-zhi, Wang Xian-pei, Yang Hong-hui, Li Mu-wei, Wang Xian-qing, Qi Da-tun, Hu Da-yi

机构信息

Department of Cardiology, People's Hospital of Zhengzhou University, Henan Institute of Cardiovascular Epidemiology, Zhengzhou 450003, China.

Email:

出版信息

Zhonghua Xin Xue Guan Bing Za Zhi. 2013 Sep;41(9):731-5.

PMID:24331798

Abstract

OBJECTIVE

To evaluate the efficacy and safety of tirofiban use immediately after successful percutaneous coronary intervention (PCI) in patients with moderate to high risk non-ST segment elevation acute coronary syndromes (NSTE-ACS).

METHODS

NSTE-ACS patients undergoing successful PCI (n = 246) were randomized by the envelope method to tirofiban group (n = 122, 10 µg/kg bolus within 3 min followed by 0.10-0.15 µg×kg(-1)×min(-1) for 36 h i.v.) or control group (n = 124, saline i.v. for 36 h). The primary efficacy composite end point was death, myocardial infarction, target vascular revascularization or ischemic stroke at 30 days. The second end point was the occurrence of composite end point at 7 days or 6 months. Key safety end points were bleeding and thrombocytopenia 3 days after PCI.

RESULTS

Baseline characteristics were well-balanced between the two groups (P > 0.05). The primary end point occurred in 0.9% (1/117) patients in the tirofiban group and 3.3% (4/123) patients of those in the control group (P = 0.40). There was no significant difference in the composite end point at 7 days [0.8% (1/122) vs. 3.2% (4/124), P = 0.38] between the groups, however, there was a trend towards lower composite efficacy end points at 6 months in tirofiban group compared to control group [0.9% (1/117) vs. 5.9% (7/118), P = 0.07]. The probability of survival free of composite end point was significantly higher in the tirofiban group than that in the control group (99.2% vs. 94.2%, log-rank test, P = 0.03). There was no GUSTO severe or moderate bleeding or severe thrombocytopenia within 3 days post-PCI. There was no significant difference in mild bleeding [13.1% (16/122) vs. 7.3% (9/124), P = 0.13] or mild thrombocytopenia [0.8% (1/122) vs. 0.8% (1/124), P = 1.00] between the groups.

CONCLUSION

Tirofiban use after successful PCI can improve 6-month event-free survival without increasing the risk of bleeding for patients with moderate to high risk NSTE-ACS.

摘要

目的

评估替罗非班在中高危非ST段抬高型急性冠状动脉综合征（NSTE-ACS）患者成功进行经皮冠状动脉介入治疗（PCI）后立即使用的有效性和安全性。

方法

将成功接受PCI的NSTE-ACS患者（n = 246）采用信封法随机分为替罗非班组（n = 122，3分钟内静脉推注10μg/kg，随后以0.10 - 0.15μg×kg⁻¹×min⁻¹静脉输注36小时）或对照组（n = 124，静脉输注生理盐水36小时）。主要疗效复合终点为30天时的死亡、心肌梗死、靶血管血运重建或缺血性卒中。次要终点为7天或6个月时复合终点的发生情况。关键安全终点为PCI术后3天的出血和血小板减少。

结果

两组基线特征均衡（P > 0.05）。替罗非班组0.9%（1/117）的患者出现主要终点，对照组为3.3%（4/123）的患者（P = 0.40）。两组7天时复合终点无显著差异[0.8%（1/122）对3.2%（4/124），P = 0.38]，然而，与对照组相比，替罗非班组6个月时复合疗效终点有降低趋势[0.9%（1/117）对5.9%（7/118），P = 0.07]。替罗非班组无复合终点生存概率显著高于对照组（99.2%对94.2%，对数秩检验，P = 0.03）。PCI术后3天内无GUSTO严重或中度出血或严重血小板减少。两组轻度出血[13.1%（16/122）对7.3%（9/124），P = 0.13]或轻度血小板减少[0.8%（1/122）对0.8%（1/124），P = 1.00]无显著差异。