依维莫司药物洗脱支架在女性患者中的安全性和有效性:SEEDS多中心注册研究亚组分析Safety and efficacy of everolimus-eluting stent in women: subgroup analysis of multicenter registry SEEDS study
徐凯,韩雅玲,杨跃进,徐波,荆全民,马颖艳,王效增,吕树铮
摘要(Abstract):
目的本文通过对SEEDS研究中的性别亚组资料进行分析,探讨依维莫司药物洗脱支架(DES)在不同性别患者中的有效性和安全性。方法选取2010年6月至2011年12月入选SEEDS试验的1900例患者,其中男性患者1408例(男性组),女性患者492例(女性组)。主要终点包括:12个月临床随访心源性死亡、Q波或非Q波心肌梗死、缺血驱动的靶血管再次血运重建复合终点。结果与男性患者相比,女性患者的年龄更大,糖尿病、高血压及高血脂的发生率更高,小血管病变的比例更高。虽然两组患者的基线治疗差异有统计学意义,但主要终点事件的发生率差异无统计学意义[6.39%(男)比4.67%(女),P=0.166]。女性患者靶血管再次血运重建的发生率相对于男性患者有降低趋势[2.84%(男)比1.42%(女),P=0.081]。结论依维莫司DES在女性患者中具有良好的安全性和有效性。
关键词(KeyWords): 药物洗脱支架;女性;靶血管再次血运重建
基金项目(Foundation): 重大新药创制创新药物研究开发技术平台建设GCP(2012ZX09303016-002)
作者(Author): 徐凯,韩雅玲,杨跃进,徐波,荆全民,马颖艳,王效增,吕树铮
参考文献(References):
- [1]李琪,刘健,卢明瑜,等.药物洗脱支架再狭窄特点及相关因素分析.中国介入心脏病学杂志,2013,21:149-152.
- [2]王佳鑫,刘越,尹新华,等.新一代冠状动脉支架与支架内血栓的临床研究进展.中国介入心脏病学杂志,2013,21:51-52.
- [3]Caixeta A,Lansky AJ,Serruys PW,et al.Clinical follow-up 3years after everolimus-and paclitaxel-eluting stents:a pooled analysis from the SPIRIT II(A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions)and SPIRIT III(A Clinical Evaluation of the Investigational Device XIENCEⅤEverolimus Eluting Coronary Stent System[EECSS]in the Treatment of Subjects With De Novo Native Coronary Artery Lesions)randomized trials.JACC Cardiovasc Interv,2010,3:1220-1228.
- [4]Xu B,Yang YJ,Han YL,et al.Validation of residual SYNTAX score with second-generation drug-eluting stents:one-year results from the prospective multicentre SEEDS study.Euro Intervention,2014,10:65-73.
- [5]Stefanini GG,Baber U,Windecker S,et al.Safety and efficacy of drug-eluting stents in women:a patient-level pooled analysis of randomised trials.Lancet,2013,382:1879-1888.
- [6]Badr S,Barbash IM,Dvir D,et al.Safety and efficacy of everolimus-eluting stents versus sirolimus-eluting stents in women.Am J Cardiol,2013,111:21-25.
- [7]Dey S,Flather MD,Devlin G,et al.Sex-related differences in the presentation,treatment and outcomes among patients with acute coronary syndromes:the Global Registry of Acute Coronary Events.Heart,2009,95:20-26.
- [8]Moscucci M,Fox KA,Cannon CP,et al.Predictors of major bleeding in acute coronary syndromes:the Global Registry of Acute Coronary Events(GRACE).Eur Heart J,2003,24:1815-1823.
- [9]Ndrepepa G,Schulz S,Neumann FJ,et al.Bleeding after percutaneous coronary intervention in women and men matched for age,body mass index,and type of antithrombotic therapy.Am Heart J,2013,166:534-540.
- [10]Ahmed B,Dauerman HL.Women,bleeding,and coronary intervention.Circulation,2013,127:641-649.
- [11]Reynolds HR.Myocardial infarction without obstructive coronary artery disease.Curr Opin Cardiol,2012,27:655-660.
- [12]Mortensen KH,Thuesen L,Kristensen IB,et al.Spontaneous coronary artery dissection:a Western Denmark Heart Registry study.Catheter Cardiovasc Interv,2009,74:710-717.
- [13]Anderson ML,Peterson ED,Brennan JM,et al.Short-and longterm outcomes of coronary stenting in women versus men:results from the National Cardiovascular Data Registry Centers for Medicare&Medicaid services cohort.Circulation,2012,126:2190-2199.