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1、 背景 真实世界里,药物支架与冠状动脉搭桥治疗冠心病多支病变的争论一直未停止。第1页/共55页解放军胸科医院解放军胸科医院 卫生部心血管疾病防治中心,阜外心血管病医院卫生部心血管疾病防治中心,阜外心血管病医院中国第一台中国第一台CABGCABG中国第一台冠状动脉造影术中国第一台冠状动脉造影术中国第一台非体外搭桥手术中国第一台非体外搭桥手术中国第一枚药物支架植入中国第一枚药物支架植入 国家心脏病中心国家心脏病中心1956196219741957199620032007 阜外一览阜外一览:方案第2页/共55页 阜外一览:阜外一览:方案CABG-手术量与死亡率(1997-2007)1537 case
2、sPCI与CAG的手术量(2003-2007)第3页/共55页阜外医院的两项注册登记研究 方案u Fuwai Hospital CABG Registry(1999now)u Fuwai Hospital PCI Registry(2002now)Am Heart J,HEART 两项注册登记研究包含了患者的详细信息;统一的参数标准;专用的电子化数据收集和报告系统。JTCVS,EJCTS,HEART第4页/共55页 研究人群(2004年5月至 2005年12月)方案 三支病变的患者 接受了单纯搭桥手术或接受至少一枚药物支架治疗的患者 先前接受过再血管化治疗 合并左主干病变 发生于24小时内的急
3、性心肌梗死 入选标准排除标准入选3,720 患者:CABG(n=1,886);DES (n=1,834)第5页/共55页 观察终点:早期:院内/30天 死亡;远期:死亡;心梗;靶血管再血管化。n 定义:死亡:任何原因导致死亡;心肌梗死:在随访过程中出现异常Q波或再入院时出现的心肌梗死 或因心肌梗死再入院;靶血管血运重建:经血运重建的血管需要再次血管化。方案第6页/共55页n 随访 临床随访 电话随访 病例记录 独立的事件鉴定委员会(内、外科医生)药物支架组平均随访33.1个月 搭桥组平均随访38.9个月 方案第7页/共55页统计分析:观察性研究存在:*选择性偏移 *潜在的混杂因素的影响 统计学
4、调整:*住院及30天死亡率:Stepwise logistic regression model *远期随访结果:Stepwise Cox proportional hazards models *倾向性积分 方案第8页/共55页p搭桥组,n=1886 896 例(47.5%)行OPCAB 1850 例(98.1%)接受至少1根乳内动脉桥 平均搭桥支数:2.86 平均末梢吻合个数:4.28 p药物支架治疗组,n=1834 当个患者平均支架植入枚数:2.680.95(2.251.25 DES and 0.430.72 BMS).平均支架直径 3.050.46mm.两联抗血小板治疗:阿司匹林+波力
5、维 结果遵照当前的指南行冠状动脉搭桥及PCI术第9页/共55页 结果第10页/共55页 结果第11页/共55页住院/30天死亡率的risk-adjusted rate无明显差别 Adjusted OR,0.779;95%CI,0.514 to 1.186;P=0.269 非调整住院/30 天死亡率:0.9%for CABG vs 0.6%for DES 结果第12页/共55页 结果 Table 1中变量经危险度调整后的对比全组倾向配对792对患者Cox 多变量分析 第13页/共55页 结果靶血管重建 治疗后36个月以内未经调整过的靶血管重建率曲线第14页/共55页 结果全组倾向配对792对患者
6、配对组的Kaplan-Meier分析第15页/共55页 结果全组倾向配对792对患者配对组的Kaplan-Meier分析第16页/共55页 结果第17页/共55页我们的主要发现我们的主要发现pCABG组有较低的死亡率,心梗发生率及靶血管再血管化率p四个亚组(糖尿病,年龄大于70岁,3支病变,2支病变)的数据分析提示CABG有更好远期安全性及有效性。讨论与评论n冠心病多支病变的再血管化:DES vs.Bypass 仍存争议!第18页/共55页终点终点CABG(%)DES(%)p死亡死亡 2.94.40.18卒中卒中 1.90.80.09心梗心梗 2.65.20.04再血管化再血管化 5.414.
7、70.001复合事件复合事件 6.47.90.39MACCE11.219.10.001 3支病变组观察第12个月Mohr EF TCT 2008;讨论与评论SYNTAX trial的结果 冠心病多支病变的再血管化冠心病多支病变的再血管化:DES vs.Bypass 仍存争议!仍存争议!第19页/共55页 讨论与评论n冠心病多支病变的再血管化:DES vs.Bypass 仍存争议!第20页/共55页 讨论与评论 CABG 治疗多支病变的优势?PCI治疗“罪犯”病变.CABG作用于血管包括了“罪犯”病变和未来可能的“罪犯”病变CABG的优势即在于此不同第21页/共55页Fuwai Database
8、 讨论与评论Cleveland Database CABG 治疗多支病变的优势?搭桥手术数量增多,围手术期结果改善第22页/共55页 阜外外科医师培训 讨论与评论LIMA前降支搭桥的金标准Tatoulis JTCVS,2004 CABG 治疗多支病变的优势?3-5年先心病手术3-5年瓣膜手术搭桥手术第23页/共55页 行CABG的患者效果更佳(死亡率,心梗率,再血管化率),尽管他们病情更重,亚组(糖尿病,年龄大于70岁,3支病变,2支病变)分析也提示CABG组有更好远期安全性及有效性。讨论与评论我们的研究提示第24页/共55页p 非随机性p 选择偏差p 单中心n 研究局限 讨论与评论鸣谢n两个
9、数据库的所有工作团队n阜外-牛津中心n统计研究中心第25页/共55页Thank you!第26页/共55页第27页/共55页Comparison of Drug-Eluting Stents and Coronary Artery Bypass Surgery for the Treatment of Multivessel Coronary DiseaseShengshou Hu M.D.,FACCDepartment of Cardiac SurgeryNational Heart Center&Fu Wai Hospital,Beijing,ChinaThree-Year Follow-
10、Up Results from a Single center第28页/共55页 BackgroundWe therefore compared the long-term safety and efficacy of PCI with DES and CABG in patients with MVD.第29页/共55页Chest HospitalChest Hospital Cardiovascular Institute&Fuwai HospitalCardiovascular Institute&Fuwai HospitalFirst CABG First CABG in Chinai
11、n ChinaFirst Coronary Angiography in ChinaFirst Coronary Angiography in ChinaFirst OPCAB in ChinaFirst OPCAB in ChinaFirst DES implantation First DES implantation in Chinain China National Heart Center National Heart Center1956196219741957199620032007 A Glance at Fuwai Hospital A Glance at Fuwai Hos
12、pital Methods第30页/共55页 A Glance at Fuwai Hospital A Glance at Fuwai Hospital MethodsCABG-Amounts and Mortalities(1997-2007)1537 cases Amounts of PCI and CAG(2003-2007)第31页/共55页Two Registries of Fuwai Hospital Methodsu Fuwai Hospital CABG Registry(1999now)u Fuwai Hospital PCI Registry(2002now)Am Hear
13、t J,HEART The two registries contain detailed information.Uniform definitions for these elements are used in our study.Data were prospectively collected with the use of a dedicated computer-based reporting system.JTCVS,EJCTS,HEART第32页/共55页 Study Population(From Apr.2004,to Dec.2005)Methods Patients
14、with MVD Treated with isolated CABG or DES(with or without BMS)Previously undergone revascularization With left main disease Acute MI within 24 hrs before revascularization InclusionExclusion3,720 MVD patients:CABG(n=1,886);DES (n=1,834)第33页/共55页 End points:Early:In-hospital/30-day death;Long-term:D
15、eath;MI;target-vessel revascularization (TVR)during follow-up.p DefinitionsDeath:death from any cause.MI:documentation of a new abnormal Q wave after the index treatment or myocardial infarctions at readmission(emergency admission with a principal diagnosis of MI).TVR:the need for revascularization
16、of the target(treated)vessel.Methods第34页/共55页 Follow-up Office visit Telephone contact Medical records Independent events adjudication committee 33.1 months for DES group 38.9 months for CABG group Methods第35页/共55页Statistical Analysis:Observational study *Treatment-selection bias *Potential confound
17、ing variables Robust adjustment was performed *Stepwise logistic regression model for in-hospital/30-day mortality *Stepwise Cox proportional hazards models for long-term outcomes.*Propensity analysis 2-tailed,and a significant level of 0.05 SPSS version 13.0 and MATLAB 6.1 Methods第36页/共55页CABG grou
18、p,n=1886 896 patients(47.5%)underwent OPCAB 1850 patients(98.1%)received at least one ITA The mean number of bypass grafts per patient:2.86 The mean number of distal anastomoses per patient:4.28 pDrug-eluting stents group,n=1834 The mean total number of stents implanted in a patient was 2.680.95(2.2
19、51.25 DES and 0.430.72 BMS).The mean stent diameter was 3.050.46mm.Dual anti-platelet therapy:Aspirin+Plavix ResultsBoth CABG and PCI with DES were performed according to current guidelines第37页/共55页 Results第38页/共55页 Results第39页/共55页 No significant difference in the risk-adjusted rate of in-hospital/
20、30-day mortality Adjusted OR,0.779;95%CI,0.514 to 1.186;P=0.269 Unadjusted in-hospital/30 day mortality 0.9%for CABG vs 0.6%for DES Results第40页/共55页 Results Adjusted for candidate variables in Table 1 Propensity matching for the entire cohort created 792 matched pairs of patientsCox multivariable an
21、alyses 第41页/共55页 ResultsTarget-vessel revascularization36-month unadjusted curves for target-vessel revascularization after the initial procedure for the entire cohort.第42页/共55页 ResultsPropensity matching for the entire cohort created 792 matched pairs of patientsKaplan-Meier analysis in the matched
22、 Cohort第43页/共55页 ResultsPropensity matching for the entire cohort created 792 matched pairs of patientsKaplan-Meier analysis in the matched Cohort第44页/共55页 Results第45页/共55页Principal Findings of Our Data Patients treated with CABG had lower rates of death,MI,and TVR than those treated with DES In fou
23、r subgroups of patients(DM,70+yrs of age,3-VD,2-VD),our data still favored CABG for long-term safety and efficacy.Discussion and CommentnMultivessel Revascularization:DES vs.Bypass Controversial!第46页/共55页End pointCABG(%)DES(%)pDeath 2.94.40.18Stroke 1.90.80.09MI 2.65.20.04Revascularization 5.414.70.
24、001Death/stroke/MI 6.47.90.39MACCE11.219.10.001 12-mo end points in 3VD subsetMohr EF TCT 2008;Discussion and CommentThe results of the much-awaited SYNTAX trial Multivessel Revascularization:DES vs.Bypass Controversial!第47页/共55页 Discussion and CommentnMultivessel Revascularization:DES vs.Bypass Con
25、troversial!第48页/共55页 Discussion and CommentIs the advantage of CABG for multivessel revascularization explicable?PCI is targeted at the“culprit”lesion or lesions.CABG is directed at the vessel including the“culprit”lesion or lesions and future culprits.The difference accounts for the superiority of
26、CABG第49页/共55页Fuwai Database Discussion and CommentCleveland Database Is the advantage of CABG for multivessel revascularization explicable?Improved peri-operative outcomes of bypass surgery第50页/共55页Surgical training in Fuwai Discussion and CommentLIMAThe Golden Standard for LADTatoulis JTCVS,2004 Is
27、 the advantage of CABG for multivessel revascularization explicable?Congenital heart surgery,3-5yrsValvular surgery,3-5yrsCABG第51页/共55页p CABG is preferred(death,MI and TVR)Albeit patients undergoing CABG were sickerp In four subgroups of patients(DM,70+yrs of age,3-VD,2-VD),our data still favored CA
28、BG for long-term safety and efficacy.Discussion and Commentn Clinical Finding of our Data 第52页/共55页The nonrandomized nature of the observational data Subjected to a selection biasSingle institutional results nStudy Limitation Discussion and Commentn Acknowledgementsp All relative staffs work for the two data-basesp Fuwai-Oxford Collaborative Research Centre p statistic research centre第53页/共55页Thank you!第54页/共55页感谢您的观看!第55页/共55页