藥物支架與冠狀動脈搭橋手術治療冠心病多支病變療效對比.ppt

藥物支架與冠狀動脈搭橋手術治療冠心病多支病變療效對比,胡盛壽 2008年12月,-來自單中心的三年隨訪結果,背景,真實世界里，藥物支架與冠狀動脈搭橋治療冠心病多支病變的爭論一直未停止。,解放軍胸科醫(yī)院,衛(wèi)生部心血管疾病防治中心，阜外心血管病醫(yī)院,中國第一臺CABG,中國第一臺冠狀動脈造影術,中國第一臺非體外搭橋手術,中國第一枚藥物支架植入,國家心臟病中心,1956,1962,1974,1957,1996,2003,2007,阜外一覽：,方案,阜外一覽：,方案,CABG- 手術量與死亡率(1997-2007),1537 cases,PCI與CAG的手術量(2003-2007),阜外醫(yī)院的兩項注冊登記研究,方案,Fuwai Hospital CABG Registry (1999now) Fuwai Hospital PCI Registry (2002now) Am Heart J, HEART,兩項注冊登記研究包含了患者的詳細信息； 統(tǒng)一的參數標準； 專用的電子化數據收集和報告系統(tǒng)。,JTCVS, EJCTS, HEART,研究人群 (2004年5月至 2005年12月),方案,三支病變的患者 接受了單純搭橋手術或接受至少一枚藥物支架治療的患者,先前接受過再血管化治療 合并左主干病變 發(fā)生于24小時內的急性心肌梗死,入選標準,排除標準,入選3,720 患者: CABG (n=1,886) ; DES (n=1,834),觀察終點: 早期: 院內 / 30天 死亡； 遠期: 死亡； 心梗； 靶血管再血管化。,定義： 死亡:任何原因導致死亡； 心肌梗死: 在隨訪過程中出現異常Q波或再入院時出現的心肌梗死 或因心肌梗死再入院； 靶血管血運重建:經血運重建的血管需要再次血管化。,方案,隨訪 臨床隨訪 電話隨訪 病例記錄 獨立的事件鑒定委員會（內、外科醫(yī)生） 藥物支架組平均隨訪33.1個月 搭橋組平均隨訪38.9個月,方案,統(tǒng)計分析 : 觀察性研究存在： * 選擇性偏移 * 潛在的混雜因素的影響 統(tǒng)計學調整： * 住院及30天死亡率：Stepwise logistic regression model * 遠期隨訪結果：Stepwise Cox proportional hazards models * 傾向性積分,方案,搭橋組, n=1886 896 例(47.5%) 行OPCAB 1850 例(98.1%) 接受至少1根乳內動脈橋 平均搭橋支數: 2.86 平均末梢吻合個數: 4.28 藥物支架治療組, n=1834 當個患者平均支架植入枚數： 2.680.95 (2.251.25 DES and 0.430.72 BMS). 平均支架直徑 3.050.46mm. 兩聯(lián)抗血小板治療: 阿司匹林 + 波力維,結果,遵照當前的指南行冠狀動脈搭橋及PCI術,結果,結果,住院/30天死亡率的risk-adjusted rate無明顯差別 Adjusted OR, 0.779; 95% CI, 0.514 to 1.186; P = 0.269,非調整住院/30 天死亡率： 0.9 % for CABG vs 0.6 % for DES,結果,結果, Table 1中變量經危險度調整后的對比 全組傾向配對792對患者,Cox 多變量分析,結果,靶血管重建,治療后36個月以內未經調整過的靶血管重建率曲線,結果,全組傾向配對792對患者,配對組的Kaplan-Meier分析,結果,全組傾向配對792對患者,配對組的Kaplan-Meier分析,結果,我們的主要發(fā)現 CABG組有較低的死亡率，心梗發(fā)生率及靶血管再血管化率 四個亞組（糖尿病，年齡大于70歲，3支病變，2支病變）的數據分析提示CABG有更好遠期安全性及有效性。,討論與評論,冠心病多支病變的再血管化: DES vs. Bypass 仍存爭議！,3支病變組觀察第12個月,Mohr EF TCT 2008;,討論與評論,SYNTAX trial的結果,冠心病多支病變的再血管化: DES vs. Bypass 仍存爭議！,討論與評論,冠心病多支病變的再血管化: DES vs. Bypass 仍存爭議！,討論與評論,CABG 治療多支病變的優(yōu)勢?,PCI治療 “罪犯” 病變 . CABG作用于血管包括了 “罪犯”病變和未來可能的“罪犯”病變 CABG的優(yōu)勢即在于此不同,Fuwai Database,討論與評論,Cleveland Database,CABG 治療多支病變的優(yōu)勢?,搭橋手術數量增多，圍手術期結果改善,阜外外科醫(yī)師培訓,討論與評論,LIMA前降支搭橋的金標準,Tatoulis JTCVS,2004,CABG 治療多支病變的優(yōu)勢?,3-5年先心病手術,3-5年瓣膜手術,搭橋手術,行CABG的患者效果更佳（死亡率，心梗率，再血管化率），盡管他們病情更重， 亞組（糖尿病，年齡大于70歲，3支病變，2支病變）分析也提示CABG組有更好遠期安全性及有效性。,討論與評論,我們的研究提示,非隨機性 選擇偏差 單中心,研究局限,討論與評論,鳴謝 兩個數據庫的所有工作團隊 阜外-牛津中心 統(tǒng)計研究中心,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-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 DES 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 Registry (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,Study 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 (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 admission 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 : 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 significant 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=1834 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 significant 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 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 patients,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 treated 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,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 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 explicable?,Improved peri-operative outcomes of bypass surgery,Surgical training