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1、药物支架与冠状动脉搭桥手术治疗冠心病多支病变疗效对比,胡盛寿 2008年12月,-来自单中心的三年随访结果,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。,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,中国第一台CABG,中国第一台冠状动脉造影术,中国第一台非体外搭桥手术,中国第一枚药物支架植入,国家心脏病中心,1956,1962,1974,1957,1996,2003,2007,阜外一览：,方案,阜外一览：,方案,CABG- 手术量与死亡率(1997-2007),1537 cases,PCI与CAG的手术量(2003-2007),阜外医院的两项注册
2、登记研究,方案,Fuwai Hospital CABG Registry (1999now) 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,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小时内的急性心肌梗死,入选标准,排除标准,入选3,720 患者: CABG (n=1,8
3、86) ; DES (n=1,834),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。,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,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,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 统计学调整： * 住院及30天死亡率：Stepwise logistic regre
4、ssion model * 远期随访结果：Stepwise Cox proportional hazards models * 倾向性积分,方案,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 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 + 波力维,结果,遵照当前的指南行冠状动脉搭桥及PCI术,结果,结果,
5、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,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,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,结果,全组倾向配对792对患者,配对组的Kaplan-Meier分析,结果,全组倾向配对792对患者,配对组的Kaplan-Meier分析,结果,我们的主要发现
6、CABG组有较低的死亡率，心梗发生率及靶血管再血管化率 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,冠心病多支病变的再血管化: DES vs. Bypass 仍存争议！,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: DES vs. Bypass 仍存争议！,讨论与评论,冠心病多支病变的再血管化: DES vs. Bypass 仍存争议！,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
7、 “罪犯”病变和未来可能的“罪犯”病变 CABG的优势即在于此不同,Fuwai Database,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,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,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,非随
8、机性 选择偏差 单中心,研究局限,讨论与评论,鸣谢 两个数据库的所有工作团队 阜外-牛津中心 统计研究中心,Thank you！,Comparison of Drug-Eluting Stents and Coronary Artery Bypass Surgery for the Treatment of Multivessel Coronary Disease,Shengshou Hu M.D., FACC Department of Cardiac Surgery National Heart Center & Fu Wai Hospital, Beijing, China,Three-
9、Year Follow-Up Results from a Single center,Background,We therefore compared the long-term safety and efficacy of PCI with DES and CABG in patients with MVD.,Chest Hospital,Cardiovascular Institute & Fuwai Hospital,First CABG in China,First Coronary Angiography in China,First OPCAB in China,First DE
10、S implantation in China,National Heart Center,1956,1962,1974,1957,1996,2003,2007,A Glance at Fuwai Hospital,Methods,A Glance at Fuwai Hospital,Methods,CABG- Amounts and Mortalities(1997-2007),1537 cases,Amounts of PCI and CAG(2003-2007),Two Registries of Fuwai Hospital,Methods,Fuwai Hospital CABG Re
11、gistry (1999now) Fuwai Hospital PCI Registry (2002now) Am Heart 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,S
12、tudy Population (From Apr. 2004, to Dec. 2005),Methods,Patients 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,Inclusion,Exclusion,3,720 MVD patients: CABG (n=1,886) ; DES
13、(n=1,834),End points: Early: In-hospital / 30-day death; Long-term: Death; MI; target-vessel revascularization (TVR) during follow-up.,Definitions Death: death from any cause. MI: documentation of a new abnormal Q wave after the index treatment or myocardial infarctions at readmission (emergency adm
14、ission with a principal diagnosis of MI). TVR: the need for revascularization of the target (treated) vessel.,Methods,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,Statistical Analysis :
15、 Observational study * Treatment-selection bias * Potential confounding 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 signific
16、ant level of 0.05 SPSS version 13.0 and MATLAB 6.1,Methods,CABG group, 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 Drug-eluting stents group, n=1
17、834 The mean total number of stents implanted in a patient was 2.680.95 (2.251.25 DES and 0.430.72 BMS). The mean stent diameter was 3.050.46mm. Dual anti-platelet therapy: Aspirin + Plavix,Results,Both CABG and PCI with DES were performed according to current guidelines,Results,Results,No significa
18、nt difference in the risk-adjusted rate of in-hospital/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,Results, Adjusted for candidate variables in Table 1 Propensity matching for the entire cohort
19、 created 792 matched pairs of patients,Cox multivariable analyses,Results,Target-vessel revascularization,36-month unadjusted curves for target-vessel revascularization after the initial procedure for the entire cohort.,Results,Propensity matching for the entire cohort created 792 matched pairs of p
20、atients,Kaplan-Meier analysis in the matched Cohort,Results,Propensity matching for the entire cohort created 792 matched pairs of patients,Kaplan-Meier analysis in the matched Cohort,Results,Principal Findings of Our Data Patients treated with CABG had lower rates of death, MI, and TVR than those t
21、reated with DES In four 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 Comment,Multivessel Revascularization: DES vs. Bypass Controversial!,12-mo end points in 3VD subset,Mohr EF TCT 2008;,Discussion and Comment,
22、The results of the much-awaited SYNTAX trial,Multivessel Revascularization: DES vs. Bypass Controversial!,Discussion and Comment,Multivessel Revascularization: DES vs. Bypass Controversial!,Discussion and Comment,Is the advantage of CABG for multivessel revascularization explicable?,PCI is targeted
23、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 CABG,Fuwai Database,Discussion and Comment,Cleveland Database,Is the advantage of CABG for multivessel revascularization ex
24、plicable?,Improved peri-operative outcomes of bypass surgery,Surgical training in Fuwai,Discussion and Comment,LIMAThe Golden Standard for LAD,Tatoulis JTCVS,2004,Is the advantage of CABG for multivessel revascularization explicable?,Congenital heart surgery, 3-5yrs,Valvular surgery, 3-5yrs,CABG,CAB
25、G is preferred (death, MI and TVR) Albeit patients undergoing CABG were sicker In four 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 Comment,Clinical Finding of our Data,The nonrandomized nature of the observational data Subjected to a selection bias Single institutional results,Study Limitation,Discussion and Comment,Acknowledgements All relative staffs work for the two data-bases Fuwai-Oxford Collaborative Research Centre statistic research centre,Thank you!,