经皮冠状动脉介入治疗指南()解读

经皮冠状动脉介入治疗指南经皮冠状动脉介入治疗指南(2009)解读解读中国医学科学院阜外心血管病医院中国医学科学院阜外心血管病医院 高润霖高润霖推荐强度的类别以国际通用的方式表达如下：推荐强度的类别以国际通用的方式表达如下：推荐强度的类别以国际通用的方式表达如下：推荐强度的类别以国际通用的方式表达如下：类类已已证证实实和和（或或）一一致致公公认认某某诊诊疗疗措措施施有有益益、有有用用和和有有效效类类某某诊诊疗疗措措施施的的有有用用性性和和有有效效性性的的证证据据尚尚有有矛矛盾盾或或存存在在不同观点不同观点 aa类类有关证据和（或）观点倾向于有用和有效。有关证据和（或）观点倾向于有用和有效。bb类类有关证据和（或）观点尚不能充分说明有用和有效。有关证据和（或）观点尚不能充分说明有用和有效。类类*已已证证实实和和（或或）一一致致公公认认某某诊诊疗疗措措施施无无用用和和无无效效并并在在有些病例可能有害，不推荐应用。有些病例可能有害，不推荐应用。指南对适应证的建议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证据的水平以国际通用的方式表达如下证据的水平以国际通用的方式表达如下证据的水平以国际通用的方式表达如下证据水平证据水平 A资料来自于多项随机临床试验或汇总分析资料来自于多项随机临床试验或汇总分析证据水平证据水平 B资料来自单项随机临床试验或多项非随机试验资料来自单项随机临床试验或多项非随机试验证据水平证据水平 C专家的意见和专家的意见和/或小型试验结果或小型试验结果指南对适应证的建议指南对适应证的建议血管重建策略选择血管重建策略选择COURAGE StudyBoden 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 indications 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 MIFollow-up:Median 4.6 yearsRandomized*Intensive pharmacologic therapy+lifestyle interventionCCS=Canadian Cardiovascular SocietySecondary outcomes:Death,MI,stroke;ACS hospitalizationNumber at RiskMedical Therapy 1138 1017 959 834 638 408 192 30PCI 1149 1013 952 833 637 417 200 35Years01234560.00.50.60.70.80.91.0PCI+OMTOptimal Medical Therapy(OMT)Hazard ratio:1.05Hazard ratio:1.0595%CI(0.87-1.27)95%CI(0.87-1.27)P=0.62P=0.627Survival Free from Death and MI(median FU 4.6 yrs)Boden WE et al.Boden WE et al.NEJMNEJM 2007;356:1503-16 2007;356:1503-16Freedom fromDeath or MI(%)Death/MIat 4.6 yrs19.0%18.5%COURAGE:Treatment effect on anginaBoden WE et al.N Engl J Med.2007;356:1503-16.P 0.001P=0.02NSAngina-free(%)NSIschemia reduction 5%with Ischemia Reduction 5%Myocardiump=0.007p=0.007PCI+OMT(n=54)PCI+OMT(n=54)OMT(n=51)OMT(n=51)In 105 pts with moderate-to-severe baseline ischemiaShaw LA.AHA 2007Death or MI Rate(%)Rates of Death or MI by IschemiaReductionp=0.001p=0.001Ischemia Reduction 5%(n=68)No Ischemia Reduction(n=37)Shaw LA.AHA 2007In 105 pts with moderate-to-severe baseline ischemia1.慢性稳定性冠心病：n nPCIPCI是缓解慢性稳定性冠心病患者症状的有效方法是缓解慢性稳定性冠心病患者症状的有效方法是缓解慢性稳定性冠心病患者症状的有效方法是缓解慢性稳定性冠心病患者症状的有效方法之一。之一。之一。之一。n n与药物治疗相比总体上不能降低死亡及与药物治疗相比总体上不能降低死亡及与药物治疗相比总体上不能降低死亡及与药物治疗相比总体上不能降低死亡及MIMI发生率，发生率，发生率，发生率，n n但有证据表明，在有较大范围心肌缺血的患者中但有证据表明，在有较大范围心肌缺血的患者中但有证据表明，在有较大范围心肌缺血的患者中但有证据表明，在有较大范围心肌缺血的患者中PCIPCI仍比药物治疗具有优势。仍比药物治疗具有优势。仍比药物治疗具有优势。仍比药物治疗具有优势。n nPCIPCI应主要用于有效药物治疗的基础上仍有症状的应主要用于有效药物治疗的基础上仍有症状的应主要用于有效药物治疗的基础上仍有症状的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。患者以及有明确较大范围心肌缺血证据的患者。患者以及有明确较大范围心肌缺血证据的患者。患者以及有明确较大范围心肌缺血证据的患者。指征指征指征指征 推荐推荐推荐推荐类别类别类别类别 证据证据证据证据水平水平水平水平 证据来源证据来源证据来源证据来源 较大范围心肌缺血的客观证据较大范围心肌缺血的客观证据较大范围心肌缺血的客观证据较大范围心肌缺血的客观证据 I IA AACME,ACIPACME,ACIP自体冠状动脉的原发病变常规置入支架自体冠状动脉的原发病变常规置入支架自体冠状动脉的原发病变常规置入支架自体冠状动脉的原发病变常规置入支架I IA ABENESTENT,BENESTENT,STRESStSTRESSt静脉旁路血管的原发病变常规置入支架静脉旁路血管的原发病变常规置入支架静脉旁路血管的原发病变常规置入支架静脉旁路血管的原发病变常规置入支架I IA ASAVED,SAVED,VenestentVenestent慢性完全闭塞病变慢性完全闭塞病变慢性完全闭塞病变慢性完全闭塞病变 a aC C外科手术高风险患者外科手术高风险患者外科手术高风险患者外科手术高风险患者 左心室射血分数左心室射血分数左心室射血分数左心室射血分数（LVEFLVEF）35%35%a aB BAWESOME AWESOME 多支血管病变无糖尿病，病变适合多支血管病变无糖尿病，病变适合多支血管病变无糖尿病，病变适合多支血管病变无糖尿病，病变适合PCI PCI a aB BBARI,ARTS,BARI,ARTS,Hoffman,TakagiHoffman,Takagi，SYNTAXSYNTAX，DaemenDaemen多支病变合并糖尿病多支病变合并糖尿病多支病变合并糖尿病多支病变合并糖尿病 b b C C经选择的无保护左主干病变经选择的无保护左主干病变经选择的无保护左主干病变经选择的无保护左主干病变 b b B BSYNTAXSYNTAX，MAIN-MAIN-COMPARECOMPARE慢性稳定性冠心病慢性稳定性冠心病PCIPCI推荐指征推荐指征 Intended all-comers study design instead of a highly selected patient population 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 optionsSYNTAX:Intended All-Comers Design with Nested Registries71%enrolled(N=3,075)All Pts with de novo 3VD and/or LM disease(N=4,337)Treatment preference(9.4%)Referring MD or pts.refused informed consent(7.0%)Inclusion/exclusion(4.7%)Withdrew before consent(4.3%)Other(1.8%)Medical treatment(1.2%)TAXUSn=903PCIn=198CABGn=1077CABGn=897no f/un=4285yr f/un=649PCIall captured w/follow upCABG2500750 w/f/uvsvsTotal enrollment N=3075Stratification:LM and DiabetesTwo Registry ArmsRandomized Armsn=1800Two Registry ArmsN=1275Randomized ArmsN=1800Heart Team(surgeon&interventionalist)PCIn=198CABGn=1077Amenable for only one treatment approachTAXUS*n=903 CABGn=897vsvsAmenable for bothtreatment optionsStratification:LM and DiabetesLM33.7%3VD66.3%LM34.6%3VD65.4%23 US Sites62 EU Sites+SYNTAX Trial Design*TAXUS ExpressTAXUS ExpressAdverse Events to 12 MonthsAdverse Events to 12 Months ITT populationEvent Rate 1.5 SE,*Fisher exact testAll DeathRevascularizationCVA(Stroke)Myocardial InfarctionTAXUS*(N=903)CABG(N=897)MACCE to 12 MonthsP=0.0015*061210200Months Since AllocationCumulative Event Rate(%)ITT population12.1%17.8%Event Rate 1.5 SE.*Fishers Exact TestTAXUS*(N=903)CABG(N=897)Symptomatic Graft Occlusion&Stent Symptomatic Graft Occlusion&Stent Thrombosis to 12 MonthsThrombosis to 12 Months3.33.33.43.4CABGCABGTAXUSTAXUSP=0.89Patients(%)n=27n=27n=28n=28ITT populationTAXUS*(N=903)CABG(N=897)MACCE to 12 MonthsLeft Main SubsetP=0.44*061220400Months Since AllocationCumulative Event Rate(%)13.6%15.8%TAXUS(N=357)CABG(N=348)Event rate 1.5 SE,*Fisher exact testITT populationPatient ProfilingPatient ProfilingPatient ProfilingPatient Profiling Local Heart team(surgeon&Local Heart team(surgeon&interventional cardiologist)interventional cardiologist)assessed each patient assessed each patient in regards toin regards to:n nPatients operative risk Patients operative risk(EuroSCOREEuroSCORE&ParsonnetParsonnet score)score)n nCoronary lesion complexity Coronary lesion complexity(Newly developed SYNTAX(Newly developed SYNTAX score)score)n nGoal:SYNTAXGoal:SYNTAX score to provide score to provide guidance on optimalguidance on optimal revascularization strategies for revascularization strategies for patients with high risk lesionspatients with high risk lesionsSianos et al,EuroIntervention 2005;1:219-227Valgimigli et al,Am J Cardiol 2007;99:1072-1081Serruys et al,EuroIntervention 2007;3:450-459BARI 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;30:649-656DominanceDominance061220400Months Since AllocationCumulative Event Rate(%)TAXUS(N=118)CABG(N=103)P=0.19*7.7%13.0%Event rate 1.5 SE,*Fisher exact testCalculated by core laboratory;ITT populationMACCE to 12 Months by SYNTAX Score TertileLow Scores(0-22)LM SubsetMean baselineSYNTAX ScoreCABG15.5 4.3TAXUS15.7 4.4061220400Months Since AllocationCumulative Event Rate(%)TAXUS(N=195)CABG(N=92)Event rate 1.5 SE,*Fisher exact testCalculated by core laboratory;ITT populationP=0.54*15.5%12.6%MACCE to 12 Months by SYNTAX Score TertileIntermediate Scores(23-32)LM Subset Mean baselineSYNTAX ScoreCABG27.2 3.0TAXUS27.0 2.7061220400Months Since AllocationCumulative Event Rate(%)TAXUS(N=135)CABG(N=150)P=0.008*25.3%12.9%Event rate 1.5 SE,*Fisher exact testCalculated by core laboratory;ITT populationMACCE to 12 Months by SYNTAX Score TertileHigh Scores(33)Left Main SubsetMean baselineSYNTAX ScoreCABG42.1 7.6TAXUS43.8 9.1Overall MACCE at 12 MonthsOverall MACCE at 12 MonthsLeft Main SubsetITT populationTAXUS*CABG(n=705)(n=91)(n=138)(n=218)(n=258)P=0.44P=1.0P=0.27P=0.29P=0.42Patients(%)MACCE to 12 Months 3VD Subset061220400Months Since AllocationCumulative Event Rate(%)P0.001*19.1%11.2%ITT populationEvent Rate 1.5 SE,*Fisher exact testTAXUS(n=546)CABG(n=549)CABGTAXUS*P=0.393 Vessel Disease*n=34n=43*per protocol and ITT populations had same outcomeCombined SafetyCombined Safety(Death/CVA/MI)(Death/CVA/MI)3VD Patients(%)MACCE to 12 Months vs SYNTAX ScoreSYNTAX Score22P P=0.10=0.10P P0.0010.001P P=0.71=0.7112-month MACCE,%SYNTAX ScoreKM Estimates,Event Rate 1.5 SE;*chi square test;raw SYNTAX score for illustrative purposes onlyRCT ITT pts;site-reported dataSYNTAX Score23-32SYNTAX Score33TAXUS*(N=903)CABG(N=897)Patient 1Patient 1Patient 1Patient 1Patient 2Patient 2Patient 2Patient 2SYNTAX SCORE 21SYNTAX SCORE 52LCx 70-90%LCx 70-90%LCx 70-90%LCx 70-90%LAD 70-90%LAD 70-90%LAD 70-90%LAD 70-90%RCA2 70-90%RCA2 70-90%RCA2 70-90%RCA2 70-90%RCA3 70-90%RCA3 70-90%RCA3 70-90%RCA3 70-90%LM 99%LM 99%LM 99%LM 99%LCx 100%LCx 100%LCx 100%LCx 100%LAD 99%LAD 99%LAD 99%LAD 99%RCA 100%RCA 100%RCA 100%RCA 100%There is 3-vessel disease and 3-vessel diseaseThere is 3-vessel disease and 3-vessel diseaseThere is 3-vessel disease and 3-vessel diseaseThere is 3-vessel disease and 3-vessel diseaseACS:PathophysiologyRuptured plaque with subocclusive thrombusRuptured plaque with subocclusive thrombusMehta SR et al.Mehta SR et al.JAMAJAMA 2005;293:2908-2917 2005;293:2908-2917Composite of Death or Myocardial InfarctionNo./Total(%)SourceSourceRoutine invasiveRoutine invasiveSelective invasiveSelective invasiveTIMI IIIBTIMI IIIB86/740(11.6)86/740(11.6)101/733(13.8)101/733(13.8)VANQWISHVANQWISH152/462(32.9)152/462(32.9)139/458(30.3)139/458(30.3)MATEMATE16/111(14.4)16/111(14.4)11/90(12.2)11/90(12.2)FRISC IIFRISC II127/1222(10.4)127/1222(10.4)174/1235(14.1)174/1235(14.1)TACTICSTACTICS81/1114(7.3)81/1114(7.3)105/1106(9.5)105/1106(9.5)VINOVINO4/64(6.3)4/64(6.3)15/67(22.4)15/67(22.4)RITARITA95/895(10.6)95/895(10.6)118/915(12.9)118/915(12.9)TotalTotal561/4608(12.2)561/4608(12.2)663/4604(14.4)663/4604(14.4)Odds Ratio(95%Cl)Favors RoutineInvasiveFavors SelectiveInvasiveOR,0.820.72-0.93P0.0010.11.010Meta-analysis of Conservative vs.Invasive Strategies in ACS9,212 randomized pts in 7 trials9,212 randomized pts in 7 trialsComposite death or MI from rand to latest FUComposite death or MI from rand to latest FU18%18%SourceSourceRoutine No./Total Routine No./Total(%)(%)Selective No./Total Selective No./Total(%)(%)TIMI IIIBTIMI IIIB218/740(29.5)218/740(29.5)265/733(36.2)265/733(36.2)VANQWISHVANQWISH275/462(59.5)275/462(59.5)287/458(62.7)287/458(62.7)MATEMATE25/111(22.5)25/111(22.5)20/90(22.2)20/90(22.2)FRISC IIFRISC II451/1222(36.9)451/1222(36.9)704/1235(57.0)704/1235(57.0)TACTICSTACTICS123/1114(11.0)123/1114(11.0)152/1106(13.7)152/1106(13.7)VINOVINO16/64(25.0)16/64(25.0)25/67(37.3)25/67(37.3)RITARITA379/863(43.9)379/863(43.9)436/882(49.4)436/882(49.4)TotalTotal1487/4576(32.5)1487/4576(32.5)1669/4571(41.3)1669/4571(41.3)Meta-analysis of Conservative vs.Invasive Strategies in ACSMehta SR et al.Mehta SR et al.JAMAJAMA 2005;293:2908-2917 2005;293:2908-2917SourceSourceRoutine No./Total Routine No./Total(%)(%)Selective No./Total Selective No./Total(%)(%)TIMI IIIBTIMI IIIB106/740(14.3)106/740(14.3)123/733(16.8)123/733(16.8)VANQWISHVANQWISH68/462(14.7)68/462(14.7)69/458(15.1)69/458(15.1)MATEMATE6/111(5.4)6/111(5.4)0/90(0)0/90(0)FRISC IIFRISC II32/1170(2.7)32/1170(2.7)81/1170(6.9)81/1170(6.9)TACTICSTACTICS80/1114(7.2)80/1114(7.2)73/1106(6.6)73/1106(6.6)VINOVINO9/64(14.1)9/64(14.1)12/67(17.9)12/67(17.9)RITARITA206/862(23.9)206/862(23.9)275/883(31.1)275/883(31.1)TotalTotal507/4525(11.2)507/4525(11.2)633/4507(14.0)633/4507(14.0)CCS Class III-IV AnginaRehospitalizationOdds Ratio(95%Cl)OR,0.77 OR,0.77 0.68-0.870.68-0.87P0.001P0.0010.11.0100.11.010OR,0.66 0.60-0.72,P0.001Favors RoutineInvasiveFavors SelectiveInvasive23%23%34%34%2.2.非非STST段抬高段抬高ACSACS：包括不稳定性心绞痛和非：包括不稳定性心绞痛和非STST段抬段抬高高MIMIn n采取早期保守策略和早期介入策略采取早期保守策略和早期介入策略n n循证医学证据表明：对危险度高的患者，早期介循证医学证据表明：对危险度高的患者，早期介入治疗策略显示了明显优势入治疗策略显示了明显优势 PCIPCI的指征是建立在危险分层的基础上。的指征是建立在危险分层的基础上。n n对于低危和早期未行对于低危和早期未行PCIPCI的非的非STST段抬高段抬高ACSACS患者出患者出院前应进行必要的评估，根据心功能、心肌缺血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。情况和再发心血管事件的危险采取相应的治疗。非非ST段抬高段抬高ACS患者患者PCI指征推荐指征推荐指征指征指征指征 推荐类别推荐类别推荐类别推荐类别证据水平证据水平证据水平证据水平 证据来源证据来源证据来源证据来源 对极高危患者对极高危患者对极高危患者对极高危患者2 h2 h内行紧急内行紧急内行紧急内行紧急PCI PCI a a B BISAR-COOL,BARIISAR-COOL,BARI对中、高危以上患者对中、高危以上患者对中、高危以上患者对中、高危以上患者72 h72 h内内内内行早期行早期行早期行早期PCI PCI I IA AFRISC II FRISC II TACTICS-TACTICS-TIMI18,Hoffman TIMI18,Hoffman,RITA 3,RITA 3对对对对PCIPCI患者常规支架置入患者常规支架置入患者常规支架置入患者常规支架置入 I IC CAMI:PathophysiologyRuptured plaque with occlusive thrombus23 Randomized Trials of PCI vs.23 Randomized Trials of PCI vs.LysisLysisP0.0001P0.0001N=7,739Keeley,Grines.Keeley,Grines.LancetLancet 2003;361:13-20 2003;361:13-20P0.0001P0.0001p=0.0002p=0.0002p=0.0002Mortality in Subgroups in SHOCK Study RevascRevasc Medical Difference RR Medical Difference RR（95%CI95%CI）P P30d Mortality30d Mortality (152)46.7 56.0 -9.3 0.83(0.07-1.04)0.11 (152)46.7 56.0 -9.3 0.83(0.07-1.04)0.1175yrs(128)41.4 56.8 -15.4 0.73(0.56-0.95)0.0175yrs(128)41.4 56.8 -15.4 0.73(0.56-0.95)0.01 75yrs75yrs(24)75.0 53.1 +21.9 1.41(0.95-2.11)0.01(24)75.0 53.1 +21.9 1.41(0.95-2.11)0.016m Mortality6m Mortality (151)50.3 63.1 -12.8 0.80(0.65-0.98)0.027 (151)50.3 63.1 -12.8 0.80(0.65-0.98)0.02775yrs(127)44.9 65.0 -20.1 0.70(0.56-0.89)0.00375yrs(24)79.2 56.0 +22.9 1.41(0.97-2.03)0.00375yrs(24)79.2 56.0 +22.9 1.41(0.97-2.03)0.0033.3.急性急性急性急性STEMISTEMI：n n循证医学证据表明，循证医学证据表明，PCIPCI能有效降低能有效降低STEMISTEMI总体死总体死亡率。亡率。n n总体死亡率降低的获益仍取决于以下因素的影响：总体死亡率降低的获益仍取决于以下因素的影响：患者发病时间患者发病时间 梗死部位及心功能状况所构成的总体危险度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医生经验及导管室人员熟练配合程度 进门进门-球囊扩张（球囊扩张（door-to-balloon door-to-balloon，D-to-BD-to-B）时间）时间 STEMI患者直接患者直接PCI推荐推荐指征指征 指征指征指征指征 推荐推荐推荐推荐类别类别类别类别证据证据证据证据水平水平水平水平 证据来源证据来源证据来源证据来源 所有所有所有所有STEMISTEMI发病发病发病发病12 h12 h内，内，内，内，D to BD to B时间时间时间时间 90 min90 min以内，能由以内，能由以内，能由以内，能由有经验的者和团队操作者有经验的者和团队操作者有经验的者和团队操作者有经验的者和团队操作者 I IA APAMI,GUSTO PAMI,GUSTO IIb,PRAGUE-IIb,PRAGUE-1,PRAGUE-1,PRAGUE-2,DANAMI-22,DANAMI-2溶栓禁忌证患者溶栓禁忌证患者溶栓禁忌证患者溶栓禁忌证患者 I IC C发病发病发病发病3 h3 h的患者更趋首选的患者更趋首选的患者更趋首选的患者更趋首选PCI PCI I IC C心原性休克，年龄心原性休克，年龄心原性休克，年龄心原性休克，年龄7575岁，岁，岁，岁，MIMI发病发病发病发病36 h36 h，休克，休克，休克，休克18 h 7575岁心原性休克，岁心原性休克，岁心原性休克，岁心原性休克，MIMI发病发病发病发病36 h36 h，休克，休克，休克，休克18 h18 h，权衡利弊后可考虑，权衡利弊后可考虑，权衡利弊后可考虑，权衡利弊后可考虑PC PC a a B BDauermanDauerman发病发病发病发病1224h1224h，仍有缺血证据，或有心功能障碍或血液动，仍有缺血证据，或有心功能障碍或血液动，仍有缺血证据，或有心功能障碍或血液动，仍有缺血证据，或有心功能障碍或血液动力学不稳定或严重心律失常力学不稳定或严重心律失常力学不稳定或严重心律失常力学不稳定或严重心律失常 a aC C常规支架置入常规支架置入常规支架置入常规支架置入 I IA ASuryapranataSuryapranata,PAMISTENT,StPAMISTENT,StononSTEMI补救补救PCI的推荐指征的推荐指征 指征指征指征指征 推荐推荐推荐推荐类别类别类别类别证据证据证据证据水平水平水平水平 证据来源证据来源证据来源证据来源 溶栓溶栓溶栓溶栓4560 min4560 min后仍有持续心肌缺血症状或后仍有持续心肌缺血症状或后仍有持续心肌缺血症状或后仍有持续心肌缺血症状或表现表现表现表现 I IB BKing,King,GershlickGershlick合并心原性休克，年龄合并心原性休克，年龄合并心原性休克，年龄合并心原性休克，年龄7575岁、发病岁、发病岁、发病岁、发病36 h36 h、休克休克休克休克18 h 18 h I IB BGershlickGershlick,MERLIN,MERLIN发病发病发病发病12 h7575岁心原性休克，岁心原性休克，岁心原性休克，岁心原性休克，MIMI发病发病发病发病36 h36 h，休克，休克，休克，休克18 h18 h，权衡利弊后可考虑补救，权衡利弊后可考虑补救，权衡利弊后可考虑补救，权衡利弊后可考虑补救PCI PCI a a B BDauermanDauerman血液动力学或心电不稳定血液动力学或心电不稳定血液动力学或心电不稳定血液动力学或心电不稳定 a a C C早期溶栓成功或未行溶栓患者择期早期溶栓成功或未行溶栓患者择期PCI的推荐指征的推荐指征指征指征指征指征 推荐类推荐类推荐类推荐类别别别别证据证据证据证据水平水平水平水平 证据来源证据来源证据来源证据来源 病变适宜病变适宜病变适宜病变适宜PCIPCI且有再发且有再发且有再发且有再发MIMI的表现的表现的表现的表现 I IC C病变适宜病变适宜病变适宜病变适宜PCIPCI且有自发或诱发缺血表现且有自发或诱发缺血表现且有自发或诱发缺血表现且有自发或诱发缺血表现 I IB BDANAMIDANAMI病变适宜病变适宜病变适宜病变适宜PCIPCI且有心原性休克或血液动力学且有心原性休克或血液动力学且有心原性休克或血液动力学且有心原性休克或血液动力学不稳定不稳定不稳定不稳定 I IB BSHOCKSHOCKLVEF40%LVEF40%，心力衰竭，严重室性心律失常，心力衰竭，严重室性心律失常，心力衰竭，严重室性心律失常，心力衰竭，严重室性心律失常，常规行常规行常规行常规行PCI PCI a a C C对无自发或诱发缺血的对无自发或诱发缺血的对无自发或诱发缺血的对无自发或诱发缺血的IRAIRA的严重狭窄于发的严重狭窄于发的严重狭窄于发的严重狭窄于发病病病病24 h24 h后行后行后行后行PCI PCI b b C CIRAIRA完全闭塞，无症状的完全闭塞，无症状的完全闭塞，无症状的完全闭塞，无症状的1 12 2支血管病变，无支血管病变，无支血管病变，无支血管病变，无严重缺血表现，血液动力学和心电学稳定，严重缺血表现，血液动力学和心电学稳定，严重缺血表现，血液动力学和心电学稳定，严重缺血表现，血液动力学和心电学稳定，不推荐发病不推荐发病不推荐发病不推荐发病24 h24 h后常规行后常规行后常规行后常规行PCIPCI A ADECOPI,OAT,DECOPI,OAT,TOSCA2TOSCA2PCI方法的选择方法的选择 DES vs BMSFrom TCT 2006DES-the good,the bad,DES-the good,the bad,and the ugly!and the ugly!48 months48 months40 40 mosmosBMSDESIncompleteIncompleteappositionappositionLate stentthrombosisAbnAbn VasomotionVasomotion*P0.001*P0.001 vs.control vs.controlSirolimus Sirolimus Control Control*Delayed Healing!Delayed Healing!AngioscopyAngioscopyBMSDESLate loss=0EosGiant cellsIVUSIVUSInflammationInflammationAll-Cause Mortality:All RCTs8,867 patients,21 trialsFavors BMSEstimate(95%CI)Weight(%)0.97(0.81,1.15)0.97(0.81,1.15),p=0.72Random Effects*Fixed Effects(I2=0.0%)Favors DESMean f/u 2.9 yrsAjay J.Kirtane and Gregg W.Stone,2008All-Cause Mortality:RCTs(On-Label)4,818 patients,10 trialsFavors DESFavors BMSEstimate(95%CI)Weight(%)1.05(0.84,1.30)1.05(0.84,1.30),p=0.69Random Effects*Fixed Effects(I2=0.0%)Mean f/u 4.0 yrsAjay J.Kirtane and Gregg W.Stone,2008All-Cause Mortality:RCTs(Off-Label)4,049 patients,12 trialsFavors DESFavors BMSEstimate(95%CI)Weight(%)0.84(0.62,1.13)0.84(0.62,1.13),p=0.24Random Effects*Fixed Effects(I2=0.0%)Mean f/u 1.5 yrsAjay J.Kirtane and Gregg W.Stone,2008All-Cause Mortality:All Registries169,595 169,595 patients,patients,31 31 registriesregistriesFavors BMSEstimate(95%CI)Weight(%)0.78(0.71,0.86),p0.0010.81(0.78,0.85)Favors DES*Random Effects(I2=71%)Fixed EffectsMean f/u 2.5 yrsAjay J.Kirtane and Gregg W.Stone,2008All-Cause Mortality:Adjusted Registries136,558 patients,19 registries136,558 patients,19 registriesFavors BMSEstimate(95%CI)Weight(%)0.79(0.71,0.89),p0.0010.82(0.79,0.86)Favors DES*Random Effects(I2=76%)Fixed EffectsMean f/u 2.7 yrsAjay J.Kirtane and Gregg W.Stone,20082006-2007DES Under Attack2007-2008Critical Reappraisal/Emerging Data2008-?Lets Resume Moving Forward!Where Do We Go From Here?DES和和BMS推荐选择指征（推荐选择指征（1）指征指征指征指征 推荐类推荐类推荐类推荐类别别别别证据证据证据证据水平水平水平水平 证据来源证据来源证据来源证据来源 DESDES应用于临床试验证实的应用于临床试验证实的应用于临床试验证实的应用于临床试验证实的DESDES有效性优于有效性优于有效性优于有效性优于BMSBMS的亚组的亚组的亚组的亚组(病情稳定的原位病变，参考血病情稳定的原位病变，参考血病情稳定的原位病变，参考血病情稳定的原位病变，参考血管直径管直径管直径管直径2.254.00 mm2.254.00 mm，病变长度，病变长度，病变长度，病变长度30 mm)30 mm)患患患患者者者者 I IA ARAVEL,SIRUS,E-RAVEL,SIRUS,E-SIRUS,C-SIRUSSIRUS,C-SIRUS，TAXUS-II,TAXUS-IVTAXUS-II,TAXUS-IV，TAXUS-VITAXUS-VI术前，医生应充分告知患者术前，医生应充分告知患者术前，医生应充分告知患者术前，医生应充分告知患者DESDES后须双重抗后须双重抗后须双重抗后须双重抗血小板治疗的时间，在肯定患者对该治疗的血小板治疗的时间，在肯定患者对该治疗的血小板治疗的时间，在肯定患者对该治疗的血小板治疗的时间，在肯定患者对该治疗的依从性后应用依从性后应用依从性后应用依从性后应用DES DES I IC CGrinesGrines对近期须要进行侵入性操作和外科手术，对近期须要进行侵入性操作和外科手术，对近期须要进行侵入性操作和外科手术，对近期须要进行侵入性操作和外科手术，1212个月内必须间断双重抗血小板治疗的患者，个月内必须间断双重抗血小板治疗的患者，个月内必须间断双重抗血小板治疗的患者，个月内必须间断双重抗血小板治疗的患者，应置入应置入应置入应置入BMSBMS或单纯或单纯或单纯或单纯PTCAPTCA（必要时置入（必要时置入（必要时置入（必要时置入BMSBMS）I IC C慢性完全闭塞病变选用慢性完全闭塞病变选用慢性完全闭塞病变选用慢性完全闭塞病变选用DES DES I IB BPACTO,PRISON IIPACTO,PRISON IIDES和和BMS推荐选择指征（推荐选择指征（2）指征指征指征指征 推荐推荐推荐推荐类别类别类别类别证据证据证据证据水平水平水平水平 证据来源证据来源证据来源证据来源 BMSBMS置入后再狭窄病变选用置入后再狭窄病变选用置入后再狭窄病变选用置入后再狭窄病变选用DES DES a a B BISAR-DESIRE,ISAR-DESIRE,SISR,RIBS-2SISR,RIBS-2分叉病变的主支血管置入分叉病变的主支血管置入分叉病变的主支血管置入分叉病变的主支血管置入DESDES、侧支球囊、侧支球囊、侧支球囊、侧支球囊扩张扩张扩张扩张 a a B BSCANDSTENTSCANDSTENT有选择的无保护左主干病变选用有选择的无保护左主干病变选用有选择的无保护左主干病变选用有选择的无保护左主干病变选用DES DES a a B BChieffo,SYNTAXChieffo,SYNTAX长病变（病变长度长病变（病变长度长病变（病变长度长病变（病变长度30 mm30 mm）选用）选用）选用）选用DESDES a a B BDawkins,TAXUSDawkins,TAXUS-V-V急性心肌梗死选用急性心肌梗死选用急性心肌梗死选用急性心肌梗死选用DES DES a a B BTYPHOON,SESATYPHOON,SESAMI,HORIZONS MI,HORIZONS AMI,GargAMI,GargTAXUS DESN=2257EXPRESS BMSN=749RandomizedRandomized1 year FU1 year FUN=2186(96.9%)N=715(95.5%)Withdrew Withdrew Lost to FU Lost to FU 181853537 72727 R 3:1HHarmonizing armonizing OOutcomes with utcomes with R Revascularevasculariz izatiationon and and S Stents in tents in AMIAMI3006 pts eligible for stent rand.3006 pts eligible for stent rand.Primary Medical Rx193Primary CABG 62Deferred PCI 2Index PCI,not eligible -PTCA only119 -Stented220UFH+GPI(n=1802)Bivalirudin(n=1800)R 1:13602 pts with STEMI3602 pts with STEMI93.1%of all stented pts were randomized2257225721322132209820982069206918681868749749697697675675658658603603Number at riskNumber at riskTAXUS DESTAXUS DESEXPRESS BMSEXPRESS BMSPrimary Efficacy Endpoint:Ischemic TLRIschemic TLR(%)Ischemic TLR(%)0 01 12 23 34 45 56 67 78 89 91010Time in MonthsTime in Months0 01 12 23 34 45 56 67 78 89 91010111112127.5%7.5%4.5%4.5%Diff 95%CI=Diff 95%CI=-3.0%-5.1,-0.9-3.0%-5.1,-0.9 HR 95%CI=HR 95%CI=0.59 0.43,0.830.59 0.43,0.83P=0.002P=0.002TAXUS DES(n=2257)TAXUS DES(n=2257)EXPRESS BMS(n=749)EXPRESS BMS(n=749)Ischemic TVR(%)012345678910Time in Months01234567891011122257225721192119207820782045204518481848749749695695669669650650598598Number at riskNumber at riskTAXUS DESTAXUS DESEXPRESS BMSE