比伐卢定联合糖蛋白IIb/IIIa用于高危经皮冠状动脉介入治疗的安全性和有效性。
Safety and efficacy of bivalirudin with glycoprotein IIb/IIIa for high-risk percutaneous coronary intervention.
作者信息
Deshpande Niteen V, Pratiti Rebecca, Admane Parag, Mukherjee Debabrata, Mardikar Harshawardhan M
机构信息
Spandan Heart Institute and Research Center, Nagpur, Maharashtra, India.
出版信息
Indian Heart J. 2012 Sep-Oct;64(5):444-8. doi: 10.1016/j.ihj.2012.07.022. Epub 2012 Jul 27.
AIMS
The aim of the study was to assess the safety and efficacy of bivalirudin + glycoprotein (Gp) IIb/IIIa inhibitor as compared to unfractionated heparin (UFH) + Gp IIb/IIIa inhibitor in high risk patients undergoing elective percutaneous coronary intervention (PCI). The primary end point was time to sheath removal and ambulation where as peri-procedure myocardial damage, access site bleeding and major adverse cardiac events (MACE) rates were secondary end points.
METHODS
One hundred and one high risk patients undergoing elective PCI were randomly assigned to either bivalirudin + GpIIb/IIIa inhibitor or UFH + Gp IIb/IIIa inhibitor. PCI was performed by standard technique and activated clotting time was monitored immediately on arrival to recovery area and every 60 min thereafter. Sheath were pulled out once ACT was below 150 seconds and patients were mobilized 6hrs after sheath were removed. Peri-procedure myocardial damage was assessed by serial Trop I levels.
RESULTS
Patient assigned to bivalirudin + tirofiban has significantly reduced time to sheath removal and ambulation as compared to those who received UFH + tirofiban (p < 0.0001) although peak Act did not differ in the groups. Peak Trop I levels were significantly lower in bivalirudin + tirofiban group (p = 0.023) and peri-procedure Trop I elevation occurred in significantly lower number of patients treated with bivalirudin + tirofiban (p = 0.029).
CONCLUSIONS
The combination of bivalirudin + tirofiban was safe and effective as compared to UFH + tirofiban in high risk patients undergoing elective PCI.
目的
本研究旨在评估比伐卢定+糖蛋白（Gp）IIb/IIIa抑制剂与普通肝素（UFH）+Gp IIb/IIIa抑制剂相比，在接受择期经皮冠状动脉介入治疗（PCI）的高危患者中的安全性和有效性。主要终点是拔除鞘管和下床活动的时间，而围手术期心肌损伤、穿刺部位出血和主要不良心脏事件（MACE）发生率为次要终点。
方法
101例接受择期PCI的高危患者被随机分为比伐卢定+GpIIb/IIIa抑制剂组或UFH+Gp IIb/IIIa抑制剂组。采用标准技术进行PCI，到达恢复区后立即监测活化凝血时间，此后每60分钟监测一次。当活化凝血时间低于150秒时拔除鞘管，拔除鞘管6小时后让患者活动。通过连续检测肌钙蛋白I水平评估围手术期心肌损伤。
结果
与接受UFH+替罗非班的患者相比，接受比伐卢定+替罗非班的患者拔除鞘管和下床活动的时间显著缩短（p<0.0001），尽管两组的活化凝血时间峰值无差异。比伐卢定+替罗非班组的肌钙蛋白I峰值水平显著较低（p = 0.023），接受比伐卢定+替罗非班治疗的患者围手术期肌钙蛋白I升高的人数显著较少（p = 0.029）。
结论
在接受择期PCI的高危患者中，与UFH+替罗非班相比，比伐卢定+替罗非班联合使用安全有效。
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