替罗非班在无ST段抬高急性冠状动脉综合征高危患者介入治疗中的临床应用研究

Safety and Efficacy of Tirofiban for Percutaneous Coronary Intervention in High-Risk Patients With Non-ST-Segment Elevation Acute Coronary Syndrome

目的:在无ST段抬高急性冠状动脉综合征(NSTE-ACS)高危患者行经皮冠状动脉介入治疗(PCI)中,观察在标准抗栓治疗基础上加用中等剂量盐酸替罗非班的疗效与安全性。方法:2005年4月-2006年1月接受药物洗脱支架(DES)植入的NSTE-ACS高危患者按有无接受替罗非班治疗分为替罗非班组(26例)和对照组(24例)。比较两组术后支架内血栓形成、不良心脏事件及出血事件的发生率。结果:两组临床、冠状动脉造影及介入治疗基线特征均无显著性差异。替罗非班组一级联合终点发生率有低于对照组的趋势,但尚无统计学意义;替罗非班组二级联合终点发生率在7 d(0％vs 16．7％,P=0．046)、30 d(3．8％vs 25％, P=0．045)和6个月(7．7％vs 33．3％,P=0．035)均显著低于对照组;二级联合终点差异主要来源于需要住院的严重不稳定心绞痛,而心性死亡、急性心肌梗死及靶血管血运重建在两组中无差别。两组7天内出血事件发生率无差别。结论:在植入DES的NSTE-ACS高危患者中,在标准抗栓治疗基础上加用中等剂量的替罗非班可减少6个月随访期间不良事件及支架内血栓的发生、不增加急性期出血并发症。

Objective： To evaluate the safety and efficacy of tirofiban for percutaneous coronary intervention（ PCI ）in high-risk patients with non-ST-segment elevation acute coronary syndrome. Methods： From April 2005 to January 2006, 50 high-risk patients with NSTE-ACS underwent drug-eluding stent （DES）implantation were divided into tirofiban group （ n = 26） or control group （ n = 24）. We compare the rate of in-stent thrombosis, major cardiovascular events, severe unstable angina and hemorrhagic events after stenting. Results： The baseline clinical and angiographic characteristics, and PCI procedures and immediate outcomes between the two groups had no significant difference. The rate of primary end point tended to be lower in tirofiban group, but there was no statistically significance between the two groups. The rate of second end point was significantly different at 7d（0% vs 16. 7% ,P = 0. 046） ,and 30 days（3. 8% vs 25% ,P =0. 045） and 6-months（7. 7% vs 33. 3% ,P =0. 035）. The difference of the second end point was due mainly to a higher rate of readmission for severe unstable angina in the control group. There was no difference in the occurrence of various bleeding events between the two groups. Conclusions： In high-risk patients with NSTE-ACS receiving DES implantation, middle dose of Tirofiban added to the triple drug anti-thrombotic regimen is safe and efficacious in terms of major adverse cardiovascular events and bleeding.