Objective To evaluate the efficacy and safety of a 150 mg high maintenance dose of clopidogrel in patients undergoing dual drug-eluting stents ( DES ) implantation for coronary bifurcation lesions. Methods A total of 146 patients undergoing double DES implantation for coronary bifurcation lesions were enrolled in our hospital from July 2007 to December 2009. After percutaneous coronary intervention,the patients were randomized to receive clopidogrel 75 mg ( n =71 )or 150 mg( n = 76 ) per day for 30 d in addition to 100 mg aspirin daily, and then all patients received 75 mg/d clopidogrel until 12 months after operation. The clinical characteristics. coronary lesion,parameters of douhle stents implantation and major cardiovascular event( MACE ) of 146 patients in a follow-up period of 12 - 24 months were analyzed. Results The ratios of fatal or non-fatal myocardial infarction ( MI ) and target vessel revascularization ( TVR ) in a follow-up period were significantly lower in 150 mg group than that in 75 mg group ( 8. 0％ v.s 15. 5％ ,P =0. 042 ; 6. 67％vs 12. 68％ .P =0. 048 ). The overall incidence of primary end point including death, MI and TVR was obviously lower in 150 mg group than that in 75 mg group ( 9. 33％ vs 18. 31％ .absolute risk reduction 8. 99％ ,P =0. 037 ). There was no significant difference in the incidence of all-cause death between 2 groups( 1. 33％ v.s 2. 82％ .P =0. 873 ). The inc:idence of stent thrombosis within 30 d and in a follow-up period of 12 - 24 months was obviously lower in 150 mg group than that in 75 mg group( 0 v.s 2. 82％ .P =0. 049 ;1. 33％ vs 4. 23％ ,P = 0. 042 ). While for secondary end points such as major and minor bleeding events, no significant difference was found between 2 groups( 1. 33％ v.s O,P =0. 343 ; 2. 67％ v.s 2. 82％ .P =0. 873 ). Conclusion A high clopidogrel maintenance dose of 150 mg daily for the first month after PCI procedure could reduce the risk of adverse events in patients undergoing double DES for coronary bifurcation lesions and seems to be safe.%目的 评价150 mg高维持剂量氯吡格雷在冠脉分叉病变患者植入双药物洗脱支架(drug eluting stents,DES)的疗效和安全性.方法 2007-06～2009-12入选146例冠脉真分叉病变采用双DES植入患者.所有入选患者术后在服用阿司匹林基础上随机分为两组,每日75 mg(对照组,n=71)或150 mg(实验组,n=75)维持剂量的氯吡格雷治疗30 d,30 d后所有患者接受每日75 mg的氯吡格雷治疗直至术后12个月.观察两组患者临床特征、冠脉病变特点以及支架植入特征,并进行随访(12-24个月)主要心血管事件、支架内血栓和出血事件.结果 实验组心梗及再次血运重建发生率均显著低于对照组(8.0% vs 15.5%,P=0.042;6.67% vs 12.68%,P=0.048).两组间全因病死率差异无统计学意义(1.33% vs 2.82%,P=0.873).实验组主要终点事件绝对风险较对照组降低8.99%(P=0.037).实验组近期、远期支架内血栓事件发生率显著低于对照组(0 vs 2.82%,P=0.049;1.33% vs 4.23%,P=0.042);两组间严重出血(1.33% vs 0,P=0.343)、轻微出血(2.67% vs 2.82%,P=0.873)风险无统计学差异.结论 150 mg高维持量氯吡格雷可降低冠脉分叉病变双DES植入的患者术后发生主要不良心血管事件、支架内血栓形成的风险,并且不增加出血事件的发生.
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