标签内与标签外应用药物洗脱支架对冠心病预后的影响  

Different clinical outcomes of on-label versus off-label drug-eluting stent implantation in coronary heart disease

作　　者：沈松萃[1] 仇兴标[1] 施鸿毓[1] 方唯一[1] 

机构地区：[1]上海交通大学附属胸科医院心内科,200030

出　　处：《中国介入心脏病学杂志》2010年第3期125-129,共5页Chinese Journal of Interventional Cardiology

基　　金：上海市胸科医院科技发展基金(Y207-02);上海市卫生局科研基金(2007110);上海市卫生局青年基金(2007Y60)

摘　　要：目的探讨标签内与标签外使用药物支架的患者术后心脏事件的影响。方法选择上海市胸科医院2004年1月至2007年12月1004例接受药物洗脱支架的冠心病患者进行回顾性研究,按照美国食品和药物管理局(FDA)推荐的药物洗脱支架适应证分为标签内和标签外两个组,观察术后主要心脏不良事件(MACE事件)及支架内血栓发生率的统计学意义,比较这两组患者的预后情况。结果标签外组各项临床基线特征中,合并心功能不全和高脂血症明显高于标签内组;冠脉特点上,标签外组目标血管狭窄程度和支架总长度大于标签内组,其他基线水平相似。在心脏事件平均36个月的随访中,标签外组MACE事件206例(28.3%),标签内组MACE事件43例(15.6%);标签外组心源性死亡率7.7%,术后心梗6.9%和靶血管血运重建(TVR)18.4%均高于标签内组的3.9%,3.6%和7.6%;标签外组中慢性阻塞性病变、桥血管病变和无保护左主干病变等一些复杂病变与心脏事件相关性较大。随访中5例支架内血栓均出现在标签外组。结论标签外组患者有更高的心脏病事件发生率,提示药物支架标签外应用带来更大事件风险。Objective To explore the influence on cardiac events of coronary heart disease patients receiving drug-eluting stents for on-label versus off-label indications in percutaneous coronary intervention （PCI）.Methods Clinical outcomes were retrospectively evaluated among 1004 patients receiving drug-eluting stents in Shanghai Chest Hospital from January 2004 to December 2007.The patients were divided into two groups （the on-label group,n=276 and the off-label group,n=728） based on the current FDA indications for drug-eluting stents.Major adverse cardiac events （MACE） and stent thrombosis （ST） were observed to evaluate the difference in prognosis between the two groups.Results Most of the baseline clinical characteristics were similar while patients in off-label group was more likely to have heart failure and hyperlipidaemia.In comparison of angiographic characteristics,the extent of stenosis of target vessel and mean total stent length per vessel were greater in the off-label group.Major adverse cardiac events （MACE） occurred in 206 （28.3%） of patients in the off-label group and 43 （15.6%） of patients in the on-label group.Cardiac death,MI and TVR occurred more frequently in patients in the off-label group （7.7%,6.9%,18.4%） than those in the on-label group （3.9%,3.6%,7.6%）.Patients receiving PCI to lesions in coronary artery bypass graft surgery,CTO and unprotected LM were more likely to have cardiac events in the off-label group.Five patients in the off-label group had late stent thrombosis and none in the on-label group.Conclusion Compared with on-label application,off-label use of drug-eluting stents is associated with a higher rate of cardiac events,suggesting an increased risk for off-label use of drug-duting stents.

关 键 词：药物洗脱支架 冠心病 标签内 预后 

分 类 号：R541.4[医药卫生—心血管疾病]