老年急性心肌梗死患者急诊经皮冠状动脉介入治疗围术期应用比伐芦定的疗效与安全性:BRIGHT研究预设亚组分析Efficacy and safety of bivalirudin during primary percutaneous coronary intervention in elderly patients with acute myocardial infarction
关绍义,王晓燕,李晶,荆全民,梁振洋,刘海伟,李毅,韩雅玲
摘要(Abstract):
目的探讨老年急性心肌梗死(acute myocardial infarction,AMI)患者急诊经皮冠状动脉介入治疗(percutaneous coronary interventions,PCI)围术期应用比伐芦定的疗效与安全性。方法选取BRIGHT研究中年龄≥65岁的老年AMI行急诊PCI患者659例,其中比伐芦定组205例,肝素组228例,肝素联合替罗非班组226例。主要终点为术后30 d净不良临床事件(net adverse clinical events,NACE),包括主要不良心脑血管事件(major adverse cardiac and cerebrovascular events,MACCE)和全部出血事件。次要终点为术后12个月的NACE事件及术后30 d和12个月的全部出血事件。安全性终点为术后30 d或12个月的支架内血栓。结果 (1)比伐芦定组术后30 d内NACE[25例(12.2%)比45例(19.9%),P=0.030]及全部出血事件[14例(6.8%)比34例(15.0%),P=0.007]发生率显著低于肝素联合替罗非班组;与肝素组相比有降低趋势[NACE:25例(12.2%)比43例(18.9%),P=0.057;全部出血事件:14例(6.8%)比25例(11.0%),P=0.133],但差异均无统计学意义。三组间术后30 d内MACCE和支架内血栓事件发生率比较,差异均无统计学意义(均P>0.05)。(2)比伐芦定组术后12个月NACE[32例(15.6%)比57例(25.2%),P=0.014]及全部出血事件[16例(7.8%)比39例(17.3%),P=0.003]发生率显著低于肝素联合替罗非班组;与肝素组相比有降低趋势[NACE:32例(15.6%)比48例(21.1%),P=0.145;全部出血事件:16例(7.8%)比29例(12.7%),P=0.094],但差异均无统计学意义。三组间术后12个月MACCE和支架内血栓事件发生率比较,差异均无统计学意义(均P>0.05)。结论老年AMI患者急诊PCI围术期应用比伐芦定安全有效,与肝素或肝素联合替罗非班相比,可降低术后30 d及12个月的NACE和出血事件风险,且不增加MACCE和支架内血栓风险。
关键词(KeyWords): 比伐芦定;抗凝;急性心肌梗死;经皮冠状动脉介入治疗;老年
基金项目(Foundation): 辽宁省科技攻关项目(2013225089);; 军队临床高新技术重大项目(2010gxjs001)
作者(Author): 关绍义,王晓燕,李晶,荆全民,梁振洋,刘海伟,李毅,韩雅玲
参考文献(References):
- [1]Genereux P,Giustino G,Witzenbichler B,et al.Incidence,predictors,and impact of post-discharge bleeding after percutaneous coronary intervention.J Am Coll Cardiol,2015,66(9):1036-1045.
- [2]Lopes RD,Alexander KP,Manoukian SV,et al.Advanced age,antithrombotic strategy,and bleeding in non-st-segment elevation acute coronary syndromes:Results from the acuity(acute catheterization and urgent intervention triage strategy)trial.J Am Coll Cardiol,2009,53(12):1021-1030.
- [3]Stone GW,Witzenbichler B,Guagliumi G,et al.Heparin plus a glycoprotein IIb/IIIa inhibitor versus bivalirudin monotherapy and paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction(HORIZONS-AMI):final 3-year results from a multicentre,randomised controlled trial.Lancet,2011,377(9784):2193-2204.
- [4]Han Y,Guo J,Zheng Y,et al.Bivalirudin vs.heparin with or without tirofiban during primary percutaneous coronary intervention in acute myocardial infarction:The BRIGHT randomized clinical trial.JAMA,2015,313(13):1336-1346.
- [5]Mehran R,Rao SV,Bhatt DL,et al.Standardized bleeding definitions for cardiovascular clinical trials:A consensus report from the bleeding academic research consortium.Circulation,2011,123(23):2736-2747.
- [6]Cutlip DE,Windecker S,Mehran R,et al.Academic Research Consortium.Clinical end points in coronary stent trials:A case for standardized definitions.Circulation,2007,115(17):2344-2351.
- [7]Warkentin TE,Levine MN,Hirsh J,et al.Heparin-induced thrombocytopenia in patients treated with low-molecular-weight heparin or unfractionated heparin.N Engl J Med,1995,332(20):1330-1335.
- [8]Authors/Task Force members,Windecker S,Kolh P,et al.2014ESC/EACTS Guidelines on myocardial revascularization:The Task Force on Myocardial Revascularization of the European Society of Cardiology(ESC)and the European Association for Cardio-Thoracic Surgery(EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions(EAPCI).Eur Heart J,2014,35(37):2541-2619.
- [9]Lincoff AM,Kleiman NS,Kereiakes DJ,et al.Long-term efficacy of bivalirudin and provisional glycoprotein IIb/IIIa blockade vs.heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary revascularization:Replace-2randomized trial.JAMA,2004,292(6):696-703.
- [10]Stone GW,Ware JH,Bertrand ME,et al.Antithrombotic strategies in patients with acute coronary syndromes undergoing early invasive management:One-year results from the acuity trial.JAMA,2007,298(21):2497-2506.
- [11]Lemesle G,De Labriolle A,Bonello L,et al.Impact of bivalirudin on in-hospital bleeding and six-month outcomes in octogenarians undergoing percutaneous coronary intervention.Catheter Cardiovasc Interv,2009,74(3):428-435.