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1、经皮冠状动脉介入治疗指南(2009)解读,中国医学科学院阜外心血管病医院 高润霖,推荐强度的类别以国际通用的方式表达如下：,指南对适应证的建议,证据的水平以国际通用的方式表达如下,指南对适应证的建议,血管重建策略选择,COURAGE Study,Boden WE et al.Am Heart J.2006;151:1173-9.Boden WE et al.N Engl J Med.2007;356:1503-16.,Optimal medical therapy*+PCI(n=1149),Optimal medical therapy(n=1138),AHA/ACC Class I/II i
2、ndications for PCI,suitable coronary artery anatomy+70%stenosis in 1 proximal epicardial vessel+objective evidence of ischemia(or 80%stenosis+CCS class III angina without provocation testing),Primary outcomes:All-cause mortality,nonfatal MI,Follow-up:Median 4.6 years,Randomized,*Intensive pharmacolo
3、gic therapy+lifestyle interventionCCS=Canadian Cardiovascular Society,Secondary outcomes:Death,MI,stroke;ACS hospitalization,Number at Risk,Medical Therapy 1138 1017 959 834 638 408 192 30PCI 1149 1013 952 833 637 417 200 35,Years,0,1,2,3,4,5,6,0.0,0.5,0.6,0.7,0.8,0.9,1.0,PCI+OMT,Optimal Medical The
4、rapy(OMT),Hazard ratio:1.0595%CI(0.87-1.27)P=0.62,7,Survival Free from Death and MI(median FU 4.6 yrs),Boden WE et al.NEJM 2007;356:1503-16,Freedom fromDeath or MI(%),Death/MIat 4.6 yrs19.0%18.5%,COURAGE:Treatment effect on angina,Boden WE et al.N Engl J Med.2007;356:1503-16.,P 0.001,P=0.02,NS,Angin
5、a-free(%),NS,Ischemia reduction 5%,%with Ischemia Reduction 5%Myocardium,p=0.007,PCI+OMT(n=54),OMT(n=51),In 105 pts with moderate-to-severe baseline ischemia,Shaw LA.AHA 2007,Death or MI Rate(%),Rates of Death or MI by IschemiaReduction,p=0.001,Ischemia Reduction 5%(n=68),No Ischemia Reduction(n=37)
6、,Shaw LA.AHA 2007,In 105 pts with moderate-to-severe baseline ischemia,1.慢性稳定性冠心病：PCI是缓解慢性稳定性冠心病患者症状的有效方法之一。与药物治疗相比总体上不能降低死亡及MI发生率，但有证据表明，在有较大范围心肌缺血的患者中PCI仍比药物治疗具有优势。PCI应主要用于有效药物治疗的基础上仍有症状的患者以及有明确较大范围心肌缺血证据的患者。,慢性稳定性冠心病PCI推荐指征,Intended all-comers study design instead of a highly selected patient pop
7、ulation Consensus physician agreement(surgeon&cardiologist)instead of inclusion&exclusion criteria And,nested registries for CABG only and PCI only to define patient characteristics and outcomes of these two unique treatment options,SYNTAX:Intended All-Comers Design with Nested Registries,23 US Site
8、s,62 EU Sites,+,SYNTAX Trial Design,*TAXUS Express,Adverse Events to 12 Months,ITT population,Event Rate 1.5 SE,*Fisher exact test,All Death,Revascularization,CVA(Stroke),Myocardial Infarction,TAXUS*(N=903),CABG(N=897),MACCE to 12 Months,P=0.0015*,ITT population,12.1%,17.8%,Event Rate 1.5 SE.*Fisher
9、s Exact Test,Symptomatic Graft Occlusion&Stent Thrombosis to 12 Months,MACCE to 12 MonthsLeft Main Subset,P=0.44*,13.6%,15.8%,Event rate 1.5 SE,*Fisher exact test,ITT population,Patient Profiling,Local Heart team(surgeon&interventional cardiologist)assessed each patient in regards to:Patients operat
10、ive risk(EuroSCORE&Parsonnet score)Coronary lesion complexity(Newly developed SYNTAX score)Goal:SYNTAX score to provide guidance on optimal revascularization strategies for patients with high risk lesions,Sianos et al,EuroIntervention 2005;1:219-227Valgimigli et al,Am J Cardiol 2007;99:1072-1081Serr
11、uys et al,EuroIntervention 2007;3:450-459,BARI classification of coronary segmentsLeaman score,Circ 1981;63:285-299Lesions classification ACC/AHA,Circ 2001;103:3019-3041Bifurcation classification,CCI 2000;49:274-283CTO classification,J Am Coll Cardiol 1997;30:649-656,Dominance,P=0.19*,7.7%,13.0%,Eve
12、nt rate 1.5 SE,*Fisher exact test,Calculated by core laboratory;ITT population,MACCE to 12 Months by SYNTAX Score TertileLow Scores(0-22)LM Subset,Event rate 1.5 SE,*Fisher exact test,Calculated by core laboratory;ITT population,P=0.54*,15.5%,12.6%,MACCE to 12 Months by SYNTAX Score TertileIntermedi
13、ate Scores(23-32)LM Subset,P=0.008*,25.3%,12.9%,Event rate 1.5 SE,*Fisher exact test,Calculated by core laboratory;ITT population,MACCE to 12 Months by SYNTAX Score TertileHigh Scores(33)Left Main Subset,Overall MACCE at 12 MonthsLeft Main Subset,ITT population,(n=705),(n=91),(n=138),(n=218),(n=258)
14、,P=0.44,P=1.0,P=0.27,P=0.29,P=0.42,Patients(%),(n=705),(n=91),(n=138),(n=218),(n=258),Patients(%),Safety at 12 MonthsDeath/CVA/MI in the Left Main Subset,P=0.29,P=1.0,P=0.72,P=0.57,P=0.11,MACCE to 12 Months 3VD Subset,P0.001*,19.1%,11.2%,ITT population,Event Rate 1.5 SE,*Fisher exact test,CABG,TAXUS
15、*,P=0.39,3 Vessel Disease*,n=34,n=43,*per protocol and ITT populations had same outcome,Combined Safety(Death/CVA/MI)3VD,Patients(%),MACCE to 12 Months vs SYNTAX Score,SYNTAX Score22,P=0.10,P0.001,P=0.71,12-month MACCE,%,SYNTAX Score,KM Estimates,Event Rate 1.5 SE;*chi square test;raw SYNTAX score f
16、or illustrative purposes only,RCT ITT pts;site-reported data,SYNTAX Score23-32,SYNTAX Score33,Patient 1,Patient 1,Patient 2,Patient 2,LCx 70-90%,RCA3 70-90%,LCx 100%,LAD 99%,RCA 100%,There is 3-vessel disease and 3-vessel disease,ACS:Pathophysiology,Ruptured plaque with subocclusive thrombus,Mehta S
17、R et al.JAMA 2005;293:2908-2917,Composite of Death or Myocardial InfarctionNo./Total(%),Odds Ratio(95%Cl),Favors RoutineInvasive,Favors SelectiveInvasive,OR,0.820.72-0.93P0.001,Meta-analysis of Conservative vs.Invasive Strategies in ACS,9,212 randomized pts in 7 trialsComposite death or MI from rand
18、 to latest FU,18%,Meta-analysis of Conservative vs.Invasive Strategies in ACS,Mehta SR et al.JAMA 2005;293:2908-2917,CCS Class III-IV Angina,Rehospitalization,Odds Ratio(95%Cl),OR,0.77 0.68-0.87P0.001,0.1,1.0,10,0.1,1.0,10,OR,0.66 0.60-0.72,P0.001,Favors RoutineInvasive,Favors SelectiveInvasive,23%,
19、34%,2.非ST段抬高ACS：包括不稳定性心绞痛和非ST段抬高MI采取早期保守策略和早期介入策略循证医学证据表明：对危险度高的患者，早期介入治疗策略显示了明显优势 PCI的指征是建立在危险分层的基础上。对于低危和早期未行PCI的非ST段抬高ACS患者出院前应进行必要的评估，根据心功能、心肌缺血情况和再发心血管事件的危险采取相应的治疗。,非ST段抬高ACS患者PCI指征推荐,AMI:Pathophysiology,Ruptured plaque with occlusive thrombus,23 Randomized Trials of PCI vs.Lysis,P0.0001,N=7,73
20、9,Keeley,Grines.Lancet 2003;361:13-20,P0.0001,p=0.0002,p=0.0002,Mortality in Subgroups in SHOCK Study,Revasc Medical Difference RR（95%CI）P30d Mortality(152)46.7 56.0-9.3 0.83(0.07-1.04)0.1175yrs(24)79.2 56.0+22.9 1.41(0.97-2.03)0.003,3.急性STEMI：循证医学证据表明，PCI能有效降低STEMI总体死亡率。总体死亡率降低的获益仍取决于以下因素的影响：患者发病时间
21、 梗死部位及心功能状况所构成的总体危险度 患者年龄及合并疾病情况 医生经验及导管室人员熟练配合程度 进门-球囊扩张（door-to-balloon，D-to-B）时间,STEMI患者直接PCI推荐指征,STEMI补救PCI的推荐指征,早期溶栓成功或未行溶栓患者择期PCI的推荐指征,PCI方法的选择,DES vs BMS,From TCT 2006,DES-the good,the bad,and the ugly!,40 mos,BMS,DES,Incompleteapposition,Late stentthrombosis,Abn Vasomotion,*P0.001 vs.control
22、,Sirolimus Control,*,*,Delayed Healing!,Angioscopy,BMS,DES,Late loss=0,Eos,Giant cells,IVUS,Inflammation,All-Cause Mortality:All RCTs,8,867 patients,21 trials,Favors BMS,Estimate(95%CI),Weight(%),0.97(0.81,1.15)0.97(0.81,1.15),p=0.72,Random Effects*Fixed Effects(I2=0.0%),Favors DES,Mean f/u 2.9 yrs,
23、Ajay J.Kirtane and Gregg W.Stone,2008,All-Cause Mortality:RCTs(On-Label),4,818 patients,10 trials,Favors DES,Favors BMS,Estimate(95%CI),Weight(%),1.05(0.84,1.30)1.05(0.84,1.30),p=0.69,Random Effects*Fixed Effects(I2=0.0%),Mean f/u 4.0 yrs,Ajay J.Kirtane and Gregg W.Stone,2008,All-Cause Mortality:RCT
24、s(Off-Label),4,049 patients,12 trials,Favors DES,Favors BMS,Estimate(95%CI),Weight(%),0.84(0.62,1.13)0.84(0.62,1.13),p=0.24,Random Effects*Fixed Effects(I2=0.0%),Mean f/u 1.5 yrs,Ajay J.Kirtane and Gregg W.Stone,2008,All-Cause Mortality:All Registries,169,595 patients,31 registries,Favors BMS,Estima
25、te(95%CI),Weight(%),0.78(0.71,0.86),p0.0010.81(0.78,0.85),Favors DES,*Random Effects(I2=71%)Fixed Effects,Mean f/u 2.5 yrs,Ajay J.Kirtane and Gregg W.Stone,2008,All-Cause Mortality:Adjusted Registries,136,558 patients,19 registries,Favors BMS,Estimate(95%CI),Weight(%),0.79(0.71,0.89),p0.0010.82(0.79
26、,0.86),Favors DES,*Random Effects(I2=76%)Fixed Effects,Mean f/u 2.7 yrs,Ajay J.Kirtane and Gregg W.Stone,2008,Where Do We Go From Here?,DES和BMS推荐选择指征（1）,DES和BMS推荐选择指征（2）,Harmonizing Outcomes with Revascularization and Stents in AMI,3006 pts eligible for stent rand.,Primary Medical Rx193Primary CABG
27、62Deferred PCI 2Index PCI,not eligible-PTCA only119-Stented220,UFH+GPI(n=1802)Bivalirudin(n=1800),3602 pts with STEMI,93.1%of all stented pts were randomized,2257,2132,2098,2069,1868,749,697,675,658,603,Number at risk,TAXUS DES,EXPRESS BMS,Primary Efficacy Endpoint:Ischemic TLR,Ischemic TLR(%),0,1,2
28、,3,4,5,6,7,8,9,10,Time in Months,0,1,2,3,4,5,6,7,8,9,10,11,12,7.5%,4.5%,Diff 95%CI=-3.0%-5.1,-0.9 HR 95%CI=0.59 0.43,0.83P=0.002,TAXUS DES(n=2257),EXPRESS BMS(n=749),Ischemic TVR(%),0,1,2,3,4,5,6,7,8,9,10,Time in Months,0,1,2,3,4,5,6,7,8,9,10,11,12,2257,2119,2078,2045,1848,749,695,669,650,598,Number
29、 at risk,TAXUS DES,EXPRESS BMS,8.7%,5.8%,Diff 95%CI=-3.0%-5.2,-0.7 HR 95%CI=0.65 0.48,0.89P=0.006,TAXUS DES(n=2257),EXPRESS BMS(n=749),Secondary Efficacy Endpoint:Ischemic TVR,Primary Safety Endpoint:Safety MACE*,Safety MACE(%),0,1,2,3,4,5,6,7,8,9,10,Time in Months,0,1,2,3,4,5,6,7,8,9,10,11,12,2257,
30、2115,2086,2057,1856,749,697,683,672,619,Number at risk,TAXUS DES,EXPRESS BMS,TAXUS DES(n=2257),EXPRESS BMS(n=749),8.1%,8.0%,Diff 95%CI=0.1%-2.1,2.4 HR 95%CI=1.02 0.76,1.36PNI=0.01PSup=0.92,*Safety MACE=death,reinfarction,stroke,or stent thrombosis,One-Year All-Cause Mortality,Mortality(%),0,1,2,3,4,
31、5,Time in Months,0,1,2,3,4,5,6,7,8,9,10,11,12,2257,2180,2161,2147,1949,749,716,712,702,648,Number at risk,TAXUS DES,EXPRESS BMS,TAXUS DES(n=2257),EXPRESS BMS(n=749),3.5%,3.5%,HR 95%CI=0.99 0.64,1.55P=0.98,One-Year Death or Reinfarction,Stent Thrombosis(ARC Definite or Probable),DES和BMS推荐选择指征（3）,PCI后
32、二级预防药物治疗,抗高血压治疗：初始治疗使用受体阻滞剂和(或)ACEI，必要时加用其他降压药物，以使血压达标（140/90 mm Hg，慢性肾病或糖尿病者应130/80 mm Hg）（I类推荐，证据水平A）。调脂治疗114：（1）使用他汀类药物达到以下目标：（1）LDL-C 2.60 mmol/L（I类推荐，证据水平A）。（2）极高危患者（如ACS、糖尿病）LDL-C 2.08 mmol/L(IIa类推荐，证据水平A）。糖尿病治疗：进行生活方式调整和药物治疗以使HbA1c6.5%（I类推荐，证据水平B）。,抗血小板/抗凝治疗：阿司匹林：无过敏及出血风险增加的支架术后患者，阿司匹林100 mg/
33、d，长期服用（I类推荐，证据水平B）。氯吡格雷：置入DES者，无高危出血风险时75 mg/d至术后至少12个月。置入BMS者，75 mg/d至少1个月，最好12个月（出血风险增高者最少2周）（I类推荐，证据水平B）。所有接受PCI但未置入支架的STEMI患者，氯吡格雷应至少持续14 d（I类推荐，证据水平B）。阿司匹林过敏或不能耐受者可用氯吡格雷替代（I类推荐，证据水平A）,感谢撰写组和专家组全体专家历时一年的努力,撰写组成员（按姓氏笔画排序）：马长生 吕树铮 杨跃进 沈卫峰 陈纪言 高润霖 傅向华 葛均波 韩雅玲 霍 勇 专家组成员：于 波 马长生 马依彤 马爱群 方 全 毛节明 吕树铮 朱文玲 朱国英 张 运 李为民 杜志民 杨跃进 沈卫峰 沈潞华 陈纪言 林曙光 柯元南 胡大一 贾国良 郭静萱 高润霖 戚文航 黄 岚 黄 峻 黄从新 黄德嘉 傅向华 曾定尹 葛均波 韩雅玲 霍 勇,World Congress of CardiologyScientific Sessions 2010Featuring the 3rd International Conference on Women,Heart Disease and Stroke16 19 June 2010|Beijing,China,www.worldcardiocongress.org,Thank you,
