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1、藥物支架與冠狀動(dòng)脈搭橋手術(shù)治療冠藥物支架與冠狀動(dòng)脈搭橋手術(shù)治療冠心病多支病變療效對(duì)比心病多支病變療效對(duì)比胡盛壽胡盛壽 2008年年12月月-來(lái)自單中心的三年隨訪結(jié)果來(lái)自單中心的三年隨訪結(jié)果 背景 真實(shí)世界里,藥物支架與冠狀動(dòng)脈搭橋治療冠心病多支真實(shí)世界里,藥物支架與冠狀動(dòng)脈搭橋治療冠心病多支病變的爭(zhēng)論一直未停止。病變的爭(zhēng)論一直未停止。 1956196219741957199620032007 方案 方案cabg- 手術(shù)量與死亡率手術(shù)量與死亡率(1997-2007)1537 casespci與與cag的手術(shù)量的手術(shù)量(2003-2007)阜外醫(yī)院的兩項(xiàng)注冊(cè)登記研究阜外醫(yī)院的兩項(xiàng)注冊(cè)登記研究 方案
2、u fuwai hospital cabg registry (1999now)u fuwai hospital pci registry (2002now) am heart j, heart 兩項(xiàng)注冊(cè)登記研究包含了患者的詳細(xì)信息; 統(tǒng)一的參數(shù)標(biāo)準(zhǔn); 專用的電子化數(shù)據(jù)收集和報(bào)告系統(tǒng)。jtcvs, ejcts, heart 研究人群研究人群 (2004年年5月至月至 2005年年12月月) 方案 三支病變的患者 接受了單純搭橋手術(shù)或接受至少一枚藥物支架治療的患者 先前接受過(guò)再血管化治療 合并左主干病變 發(fā)生于24小時(shí)內(nèi)的急性心肌梗死 入選標(biāo)準(zhǔn)入選標(biāo)準(zhǔn)排除標(biāo)準(zhǔn)排除標(biāo)準(zhǔn)入選入選3,720 患者患者
3、: cabg (n=1,886) ; des (n=1,834)n 觀察終點(diǎn): 早期: 院內(nèi) / 30天 死亡; 遠(yuǎn)期: 死亡; 心梗; 靶血管再血管化。 n 定義:死亡:任何原因?qū)е滤劳觯?心肌梗死: 在隨訪過(guò)程中出現(xiàn)異常q波或再入院時(shí)出現(xiàn)的心肌梗死 或因心肌梗死再入院;靶血管血運(yùn)重建:經(jīng)血運(yùn)重建的血管需要再次血管化。 方案n 隨訪 臨床隨訪 電話隨訪 病例記錄 獨(dú)立的事件鑒定委員會(huì)(內(nèi)、外科醫(yī)生) 藥物支架組平均隨訪33.1個(gè)月 搭橋組平均隨訪38.9個(gè)月 方案n統(tǒng)計(jì)分析統(tǒng)計(jì)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(jì)學(xué)調(diào)整: * 住院及30天死亡率:step
4、wise logistic regression model * 遠(yuǎn)期隨訪結(jié)果:stepwise cox proportional hazards models * 傾向性積分 方案p搭橋組, n=1886 896 例(47.5%) 行opcab 1850 例(98.1%) 接受至少1根乳內(nèi)動(dòng)脈橋 平均搭橋支數(shù): 2.86 平均末梢吻合個(gè)數(shù): 4.28 p藥物支架治療組, n=1834 當(dāng)個(gè)患者平均支架植入枚數(shù): 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(jié)果遵照當(dāng)前的指南
5、行冠狀動(dòng)脈搭橋及pci術(shù) 結(jié)果 結(jié)果住院/30天死亡率的risk-adjusted rate無(wú)明顯差別 adjusted or, 0.779; 95% ci, 0.514 to 1.186; p = 0.269 非調(diào)整住院/30 天死亡率: 0.9 % for cabg vs 0.6 % for des 結(jié)果 結(jié)果 table 1中變量經(jīng)危險(xiǎn)度調(diào)整后的對(duì)比全組傾向配對(duì)792對(duì)患者cox 多變量分析 結(jié)果靶血管重建 治療后治療后3636個(gè)月以內(nèi)未經(jīng)調(diào)整過(guò)的靶血管重建率曲線個(gè)月以內(nèi)未經(jīng)調(diào)整過(guò)的靶血管重建率曲線 結(jié)果全組傾向配對(duì)全組傾向配對(duì)792對(duì)患者對(duì)患者配對(duì)組的配對(duì)組的kaplan-meier分
6、析分析 結(jié)果全組傾向配對(duì)全組傾向配對(duì)792對(duì)患者對(duì)患者配對(duì)組的配對(duì)組的kaplan-meier分析分析 結(jié)果我們的主要發(fā)現(xiàn)我們的主要發(fā)現(xiàn)pcabg組有較低的死亡率,心梗發(fā)生率及靶血管再血管化率p四個(gè)亞組(糖尿病,年齡大于70歲,3支病變,2支病變)的數(shù)據(jù)分析提示cabg有更好遠(yuǎn)期安全性及有效性。 討論與評(píng)論討論與評(píng)論n冠心病多支病變的再血管化冠心病多支病變的再血管化: des vs. bypass 仍存爭(zhēng)議!仍存爭(zhēng)議!終點(diǎn)終點(diǎn)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 5.414.70.001復(fù)合事
7、件復(fù)合事件 6.47.90.39macce11.219.10.001 3支病變組觀察第支病變組觀察第12個(gè)月個(gè)月mohr ef tct 2008; 討論與評(píng)論討論與評(píng)論syntax trial的結(jié)果的結(jié)果 n冠心病多支病變的再血管化冠心病多支病變的再血管化: des vs. bypass 仍存爭(zhēng)議!仍存爭(zhēng)議! 討論與評(píng)論討論與評(píng)論n冠心病多支病變的再血管化冠心病多支病變的再血管化: des vs. bypass 仍存爭(zhēng)議!仍存爭(zhēng)議! 討論與評(píng)論討論與評(píng)論 cabg 治療多支病變的優(yōu)勢(shì)治療多支病變的優(yōu)勢(shì)? pci治療治療 “罪犯罪犯” 病變病變 . cabg作用于作用于血管血管包括包括了了 “罪
8、犯罪犯”病變和未來(lái)可病變和未來(lái)可能的能的“罪犯罪犯”病變病變cabg的優(yōu)勢(shì)即在于此不的優(yōu)勢(shì)即在于此不同同fuwai database 討論與評(píng)論討論與評(píng)論cleveland database cabg 治療多支病變的優(yōu)勢(shì)治療多支病變的優(yōu)勢(shì)? 搭橋手術(shù)數(shù)量增多,圍手術(shù)期結(jié)果改善搭橋手術(shù)數(shù)量增多,圍手術(shù)期結(jié)果改善 阜外外科醫(yī)師培訓(xùn) 討論與評(píng)論討論與評(píng)論lima前降支搭橋的金標(biāo)準(zhǔn)tatoulistatoulis jtcvs,2004jtcvs,2004 cabg 治療多支病變的優(yōu)勢(shì)治療多支病變的優(yōu)勢(shì)? 3-5年先心病手術(shù)年先心病手術(shù)3-5年瓣膜手術(shù)年瓣膜手術(shù)搭橋手術(shù)搭橋手術(shù) 行cabg的患者效果更佳
9、(死亡率,心梗率,再血管化率),盡管他們病情更重病情更重, 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(yuǎn)期安全性及有效性。 討論與評(píng)論討論與評(píng)論我們的研究提示我們的研究提示p 非隨機(jī)性p 選擇偏差p 單中心n 研究局限 討論與評(píng)論討論與評(píng)論鳴謝鳴謝n兩個(gè)數(shù)據(jù)庫(kù)的所有工作團(tuán)隊(duì)兩個(gè)數(shù)據(jù)庫(kù)的所有工作團(tuán)隊(duì)n阜外阜外-牛津中心牛津中心n統(tǒng)計(jì)研究中心統(tǒng)計(jì)研究中心thank you!comparison of drug-eluting stents and coronary artery bypass surgery for the treatment of multive
10、ssel coronary diseaseshengshou hu m.d., faccdepartment of cardiac surgerynational heart center & fu wai hospital, beijing, chinathree-year follow-up results from a single center backgroundwe therefore compared the long-term safety and efficacy of pci with des and cabg in patients with mvd. 19561
11、96219741957199620032007 methods methodscabg- amounts and mortalities(1997-2007)1537 cases amounts of pci and cag(2003-2007)two registries of fuwai hospital methodsu fuwai hospital cabg registry (1999now)u fuwai hospital pci registry (2002now) am heart j, heart the two registries contain detailed inf
12、ormation. 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
13、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)n end points: early: in-hospital / 30-day death; long-term: death; mi; target-vessel revascularization (tv
14、r) 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 of the target (treated) vessel. meth
15、ods follow-up office visit telephone contact medical records independent events adjudication committee 33.1 months for des group 38.9 months for cabg group methodsnstatistical analysis : observational study * treatment-selection bias * potential confounding variables robust adjustment was performed
16、* 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 methodsncabg group, n=1886 896 patients (47.5%) underwent opcab
17、 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 (2.251.25 des and 0.430.72 bms). the mean
18、 stent diameter was 3.050.46mm. dual anti-platelet therapy: aspirin + plavix resultsboth 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
19、; 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 patientscox multivariable analyses resultstarget-vessel revascularization36-month una
20、djusted curves for target-vessel revascularization after the initial procedure for the entire cohort. resultspropensity matching for the entire cohort created 792 matched pairs of patientskaplan-meier analysis in the matched cohort resultspropensity matching for the entire cohort created 792 matched
21、 pairs of patientskaplan-meier analysis in the matched cohort resultsprincipal 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
22、safety and efficacy. discussion and commentnmultivessel revascularization: des vs. bypass controversial!end pointcabg (%)des (%)pdeath 2.94.40.18stroke 1.90.80.09mi 2.65.20.04revascularization 5.414.70.001death/stroke/mi 6.47.90.39macce11.219.10.001 12-mo end points in 3vd subsetmohr ef tct 2008; di
23、scussion and commentthe results of the much-awaited syntax trial nmultivessel revascularization: des vs. bypass controversial! discussion and commentnmultivessel revascularization: des vs. bypass controversial! discussion and commentis the advantage of cabg for multivessel revascularization explicab
24、le? 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 cabgfuwai database discussion and commentcleveland database is the advantage of cabg for multivessel revascularization explicable? improved peri-operative outcomes of bypass surgerysurg
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