冠心病介入治疗再认识.ppt

武汉亚洲心脏病医院武汉亚洲心脏病医院朱国英朱国英 多支血管病变血运重建多支血管病变血运重建多支血管病变血运重建多支血管病变血运重建单纯球囊扩张（单纯球囊扩张（单纯球囊扩张（单纯球囊扩张（PTCAPTCA）时代）时代）时代）时代 多个临床试验结果有利于多个临床试验结果有利于多个临床试验结果有利于多个临床试验结果有利于CABGCABGnn CABGCABG完全血运重建率高完全血运重建率高完全血运重建率高完全血运重建率高nn PCIPCI再次血运重建率高再次血运重建率高再次血运重建率高再次血运重建率高100100909080807070606050500 06060120120180180240240300300360360DaysDays%Death/MI/CABG/Re-PTCADeath/MI/CABG/Re-PTCACABRI:CABG(91%)CABRI:PTCA(59%)32%14%Event free survival My rosy prophecyMy rosy prophecyARTS2:Eluting STENT(95%)ARTS2:Eluting STENT(95%)ARTS2:CABG(90%)ARTS2:CABG(90%)CABRI:1994CABRI:1994ARTS :1999ARTS :1999ARTS 2:2003,FREEDOMARTS 2:2003,FREEDOMARTS:CABG(89%)ARTS:STENT(75%)-5%Andreas Andreas GruentzigsGruentzigs Lecture,ESC 2000 Amsterdam Lecture,ESC 2000 Amsterdam100100909080807070606050500 06060120120180180240240300300360360DaysDays%Death/MI/CABG/Re-PTCADeath/MI/CABG/Re-PTCACABRI:CABG(91%)CABRI:PTCA(59%)32%14%Event free survival My rosy prophecyMy rosy prophecyARTS2:Eluting STENT(95%)ARTS2:Eluting STENT(95%)ARTS2:CABG(90%)ARTS2:CABG(90%)CABRI:1994CABRI:1994ARTS :1999ARTS :1999ARTS 2:2003,FREEDOMARTS 2:2003,FREEDOMARTS:CABG(89%)ARTS:STENT(75%)-5%Andreas Andreas GruentzigsGruentzigs Lecture,ESC 2000 Amsterdam Lecture,ESC 2000 AmsterdamCurrent Trials of CABG vs.DESCurrent Trials of CABG vs.DESSYNTAX SYNTAX FREEDOMFREEDOMCOMBATCOMBATSYNTAX Trial DesignSYNTAX Trial DesignSYNTAX SYNTAX 是多支血管血运重建的是多支血管血运重建的是多支血管血运重建的是多支血管血运重建的里程碑研究里程碑研究里程碑研究里程碑研究ll 第一个随机、对照临床研究第一个随机、对照临床研究第一个随机、对照临床研究第一个随机、对照临床研究ll 设计基础设计基础设计基础设计基础：回顾分析了回顾分析了回顾分析了回顾分析了 2003 20042003 2004 年年年年 104104家医疗中心的家医疗中心的家医疗中心的家医疗中心的 血运重建（血运重建（血运重建（血运重建（CABGCABG或或或或PCIPCI）12,072 12,072 例患者例患者例患者例患者:1/3:1/3为左主干，为左主干，为左主干，为左主干，2/32/3为三支病变为三支病变为三支病变为三支病变 治疗策略：治疗策略：治疗策略：治疗策略：2/32/3 选择选择选择选择CABGCABG，1/31/3 选择选择选择选择PCIPCISYNTAXSYNTAXSYNTAX是多支血管病变治疗策略真实世界的研究是多支血管病变治疗策略真实世界的研究是多支血管病变治疗策略真实世界的研究是多支血管病变治疗策略真实世界的研究是多支血管病变治疗策略真实世界的研究是多支血管病变治疗策略真实世界的研究Patient Characteristics Patient Characteristics(1)(1)(1)Randomized CohortRandomized CohortRandomized CohortPatient Characteristics Patient Characteristics(2)(2)(2)Randomized CohortRandomized CohortRandomized CohortAll Cause Death to 12 MonthsAll Cause Death to 12 MonthsMyocardial infarction to 12 MonthsMyocardial infarction to 12 MonthsAll Cause DeathAll Cause DeathAll Cause Death /CVACVACVA /MI to 12 MonthsMI to 12 MonthsMI to 12 MonthsSymptomatic Graft Occlusion Symptomatic Graft Occlusion Symptomatic Graft Occlusion StentStentStent Thrombosis to 12 Months Thrombosis to 12 Months Thrombosis to 12 MonthsMACCE to 12 MonthsMACCE to 12 MonthsMACCE to 12 MonthsRepeat Revascularization to 12 MonthsRepeat Revascularization to 12 MonthsRepeat Revascularization to 12 MonthsCVA to 12 MonthsCVA to 12 Months12 Month LM Subgroup MACCE Rates12 Month LM Subgroup MACCE Rates12 Month LM Subgroup MACCE Rates12 Month LM Subgroup MACCE Rates12 Month LM Subgroup MACCE Rates12 Month LM Subgroup MACCE RatesOutcome according to Diabetic StatusOutcome according to Diabetic StatusOutcome according to Diabetic StatusConclusionsConclusionsPatient ProfilingPatient ProfilingThere is 3-vessel disease and 3-vessel disease There is 3-vessel disease and 3-vessel disease There is 3-vessel disease and 3-vessel disease 研究结果：研究结果：研究结果：研究结果：研究结果：研究结果：121212月月月月月月 MACE-SYNTAX SCOREMACE-SYNTAX SCOREMACE-SYNTAX SCOREPatrick W.Patrick W.SerruysSerruys：对于合并左主干冠心病患者：对于合并左主干冠心病患者：对于合并左主干冠心病患者：对于合并左主干冠心病患者：DESDES 和和和和 CABGCABG 的有效性和安全性相近似的有效性和安全性相近似的有效性和安全性相近似的有效性和安全性相近似 对于采用对于采用对于采用对于采用SYNTAXSYNTAX计分系统评估的低计分组和中等计分系统评估的低计分组和中等计分系统评估的低计分组和中等计分系统评估的低计分组和中等 计分组的左主干合并单支、双支或三支病变患者：计分组的左主干合并单支、双支或三支病变患者：计分组的左主干合并单支、双支或三支病变患者：计分组的左主干合并单支、双支或三支病变患者：DESDES是更为合理的治疗选择是更为合理的治疗选择是更为合理的治疗选择是更为合理的治疗选择 对于高计分（对于高计分（对于高计分（对于高计分（3333分）组左主干合并多支病变患者：分）组左主干合并多支病变患者：分）组左主干合并多支病变患者：分）组左主干合并多支病变患者：CABGCABG是较为合理的治疗选择是较为合理的治疗选择是较为合理的治疗选择是较为合理的治疗选择SYNTAX SYNTAX 的意义的意义的意义的意义ll Patrick Patrick SerruysSerruys 评论：评论：评论：评论：首次比较了首次比较了首次比较了首次比较了DESDES和和和和CABGCABG对复杂、疑难病变对复杂、疑难病变对复杂、疑难病变对复杂、疑难病变 患者的影响患者的影响患者的影响患者的影响 PCI PCI和和和和CABG CABG 对主要终点事件的影响未分胜负对主要终点事件的影响未分胜负对主要终点事件的影响未分胜负对主要终点事件的影响未分胜负 结果显示结果显示结果显示结果显示PCIPCI和和和和CABGCABG都能改善预后都能改善预后都能改善预后都能改善预后ll PetrPetr WidimskyWidimsky 评论：评论：评论：评论：研究结果对外科和介入医生皆大欢喜研究结果对外科和介入医生皆大欢喜研究结果对外科和介入医生皆大欢喜研究结果对外科和介入医生皆大欢喜 对于左主干和三支病变患者，需心内科和对于左主干和三支病变患者，需心内科和对于左主干和三支病变患者，需心内科和对于左主干和三支病变患者，需心内科和 外科共同决定治疗策略外科共同决定治疗策略外科共同决定治疗策略外科共同决定治疗策略 患者应参与治疗决策，选择开胸手术还是患者应参与治疗决策，选择开胸手术还是患者应参与治疗决策，选择开胸手术还是患者应参与治疗决策，选择开胸手术还是 承担再次血管重建的风险承担再次血管重建的风险承担再次血管重建的风险承担再次血管重建的风险 SYNTAX SYNTAX 的意义的意义的意义的意义SYNTAXSYNTAXSTEMI STEMI 的血运重建方式的血运重建方式的血运重建方式的血运重建方式 STST段抬高心肌梗死段抬高心肌梗死段抬高心肌梗死段抬高心肌梗死溶栓溶栓溶栓溶栓直接直接直接直接PCIPCI溶栓后溶栓后溶栓后溶栓后PCIPCICABGCABG直接直接 PCI 和溶栓疗法的比较和溶栓疗法的比较 23 23 个随机研究的汇萃分析个随机研究的汇萃分析个随机研究的汇萃分析个随机研究的汇萃分析 （n=7739n=7739）PTCA Keeley E.et al.,Lancet 2003;361:13-20.P=0.0002P=0.0003P0.0001P0.0001P0.0001P=0.0004P=0.032P0.0001DeathDeath,no SHOCKdataReMIRec.IschTotal StrokeHem.StrokeMajor BleedDeathMICVAFibrinolysis (%)Events(%)EventsDES 能否常规用于直接能否常规用于直接 PCI？H Harmonizing armonizing OOutcomes with utcomes with R Revascularevascularizizatiationon and and S Stents in tents in AMIAMI3602 pts with STEMI with symptom onset 12 hours3602 pts with STEMI with symptom onset 12 hoursEmergent angiography,followed by triage toEmergent angiography,followed by triage toPrimary PCIPrimary PCICABGCABG Medical RxMedical Rx UFH+GP UFH+GP IIb/IIIaIIb/IIIa inhibitor inhibitor(abciximababciximab or or eptifibatideeptifibatide)BivalirudinBivalirudin monotherapymonotherapy(provisional GP(provisional GP IIb/IIIaIIb/IIIa)Aspirin,Aspirin,thienopyridinethienopyridine R R 1:11:13000 pts eligible for stent randomization3000 pts eligible for stent randomization R R 3:13:1Bare metal EXPRESS Bare metal EXPRESS stentstentPaclitaxelPaclitaxel-eluting TAXUS-eluting TAXUS stentstentClinical FU at 30 days,6 months,1 year,and thenClinical FU at 30 days,6 months,1 year,and thenClinical FU at 30 days,6 months,1 year,and thenyearly through 5 years;yearly through 5 years;yearly through 5 years;angioangioangio FU at 13 months FU at 13 months FU at 13 monthsStent Randomization HypothesesIn patients with STEMI undergoing primary PCI,In patients with STEMI undergoing primary PCI,the use of the use of paclitaxelpaclitaxel-eluting TAXUS-eluting TAXUS stentsstents rather rather than bare metal EXPRESS than bare metal EXPRESS stentsstents will be:will be:Efficacious,as evidenced by reduced rates of Efficacious,as evidenced by reduced rates of ischemia-driven target lesion revascularization ischemia-driven target lesion revascularization at 1-year and angiographic binary at 1-year and angiographic binary restenosisrestenosis at 13 months;at 13 months;andand Safe,with non-inferior rates of the composite Safe,with non-inferior rates of the composite measure of death,measure of death,reinfarctionreinfarction,stentstent thrombosis thrombosis or stroke at 1-yearor stroke at 1-yearHorizons Enrollment-CentersUSA(57)(1)Spain(1)Spain(6)UK(6)UK(2)Norway(2)NorwayPoland(9)Poland(9)Germany(16)Germany(16)Austria(5)Austria(5)(3)Netherlands(3)NetherlandsItaly(2)Italy(2)Argentina(12)Argentina(12)Israel(10)Israel(10)3,602 pts randomized at 123 centers in 11 countriesbetween March 25th,2005 and May 7th,2007TAXUS 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 3:1H Harmonizing armonizing OOutcomes with utcomes with R Revascularevascularizizatiationon and and S Stents in tents in AMIAMI3006 pts eligible for 3006 pts eligible for stentstent rand.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 BMSEXPRESS BMS8.7%5.8%Diff 95%CI=-3.0%-5.2,-0.7 HR 95%CI=0.65 0.48,0.89P=0.006TAXUS DES(n=2257)TAXUS DES(n=2257)EXPRESS BMS(n=749)EXPRESS BMS(n=749)Secondary Efficacy Endpoint:Ischemic TVRPrimary Safety Endpoint:Safety MACE*Safety MACE(%)Safety MACE(%)0 01 12 23 34 45 56 67 78 89 91010Time in MonthsTime in Months0 01 12 23 34 45 56 67 78 89 91010111112122257225721152115208620862057205718561856749749697697683683672672619619Number at riskNumber at riskTAXUS DESTAXUS DESEXPRESS BMSEXPRESS BMSTAXUS DES(n=2257)TAXUS DES(n=2257)EXPRESS BMS(n=749)EXPRESS BMS(n=749)8.1%8.1%8.0%8.0%Diff 95%CI=Diff 95%CI=0.1%-2.1,2.40.1%-2.1,2.4 HR 95%CI=HR 95%CI=1.02 0.76,1.361.02 0.76,1.36P PNINI=0.01=0.01P PSupSup=0.92=0.92*Safety MACE=death,reinfarction,stroke,or stent thrombosis*Safety MACE=death,reinfarction,stroke,or stent thrombosisOne-Year All-Cause MortalityMortality(%)012345Time in Months01234567891011122257225721802180216121612147214719491949749749716716712712702702648648Number at riskNumber at riskTAXUS DESTAXUS DESEXPRESS BMSEXPRESS BMSTAXUS DES(n=2257)TAXUS DES(n=2257)EXPRESS BMS(n=749)EXPRESS BMS(n=749)3.5%3.5%HR 95%CI=0.99 0.64,1.55P=0.98One-Year Death or ReinfarctionDeath or MI(%)012345678Time in Months01234567891011122257225721402140211021102083208318821882749749703703689689678678625625Number at riskNumber at riskTAXUS DESTAXUS DESEXPRESS BMSEXPRESS BMSTAXUS DES(n=2257)TAXUS DES(n=2257)EXPRESS BMS(n=749)EXPRESS BMS(n=749)7.0%6.8%HR 95%CI=0.97 0.70,1.32P=0.83Stent Thrombosis(ARC Definite or Probable)2238223821222122209820982078207818841884744744701701694694683683629629Number at riskNumber at riskTAXUS DESTAXUS DESEXPRESS BMSEXPRESS BMSStent Thrombosis(%)Stent Thrombosis(%)0 01 12 23 34 4Time in MonthsTime in Months0 01 12 23 34 45 56 67 78 89 9101011111212TAXUS DES(n=2238)TAXUS DES(n=2238)EXPRESS BMS(n=744)EXPRESS BMS(n=744)3.4%3.1%HR 95%CI=0.92 0.58,1.45P=0.72Angiographic Follow-upTAXUS DESN=1348EXPRESS BMSN=452RandomizedRandomizedEligibleEligibleN=1308N=4411800 consecutive eligible pts assigned 1800 consecutive eligible pts assigned to 13 month angiographic FU*to 13 month angiographic FU*Randomized in Randomized in stentstent arm;arm;stentstent procedure successful(DS 10%,TIMI-3 flow,procedure successful(DS 10%,TIMI-3 flow,NHLBI type A NHLBI type A peri-stentperi-stent dissection);no dissection);no stentstent thrombosis or CABG thrombosis or CABG w/iw/i 30 days 30 days40401111 Died before Died before angioangio FU FU N=942(72.0%)N=307(69.6%)CompletedCompletedAngioAngio FU FU366366134134 AngioAngio FU not performed FU not performed Not received/analyzable Not received/analyzable Out of window Out of window 28283 314140 0N=911N=293AnalyzedAnalyzed Lesions Lesions 10811081332332Binary Analysis Segment Restenosis at 13 MonthsPatient and Lesion Level Analysis*RR 95%CI=RR 95%CI=0.44 0.33,0.570.44 0.33,0.57P0.0001P0.0001*ITT:Includes all stent randomized lesions,whether or not a stent*ITT:Includes all stent randomized lesions,whether or not a stent was implanted,and whether or not non study stents were placedwas implanted,and whether or not non study stents were placed*Any lesion with restenosis*Any lesion with restenosis per pt restenosis per pt restenosisRR 95%CI=RR 95%CI=0.44 0.33,0.570.44 0.33,0.57P0.0001P0.0001Major 2 endpointAngiographic Late Loss at 13 Month Lesions with Stents ImplantedP0.0001P0.0001P0.0001P0.0001 0.42 0.54 0.64 0.70 P=0.18P=0.18P=0.07P=0.07 0.56 0.64 0.47 0.50 Binary Angiographic Restenosis at 13 MonthsLesions with Stents ImplantedRR 95%CI=RR 95%CI=0.42 0.32,0.540.42 0.32,0.54P0.0001P0.0001RR 95%CI=RR 95%CI=0.39 0.29,0.520.39 0.29,0.52P0.0001P0.0001P=0.13P=0.13P=0.42P=0.42ConclusionsIn this large-scale,prospective,randomized trial of In this large-scale,prospective,randomized trial of pts with STEMI undergoing primary stenting,the pts with STEMI undergoing primary stenting,the implantation of paclitaxel-eluting TAXUS stents implantation of paclitaxel-eluting TAXUS stents compared to bare metal EXPRESS stents resulted in:compared to bare metal EXPRESS stents resulted in:A significant 41%reduction in the 1-year primary A significant 41%reduction in the 1-year primary efficacy endpoint of ischemia-driven TLR,and a efficacy endpoint of ischemia-driven TLR,and a significant 56%reduction in the 13 month major significant 56%reduction in the 13 month major secondary efficacy endpoint of binary restenosissecondary efficacy endpoint of binary restenosis Non inferior rates of the primary composite safety Non inferior rates of the primary composite safety endpoint of all cause death,reinfarction,stent endpoint of all cause death,reinfarction,stent thrombosis or stroke at 1-year thrombosis or stroke at 1-year ConclusionsThe long-term safety and efficacy profile of paclitaxel-eluting TAXUS stents compared to bare metal EXPRESS stents in STEMI will be determined by the ongoing 5 year follow-up of patients randomized in the HORIZONS-AMI trial慢性稳定型心绞痛慢性稳定型心绞痛慢性稳定型心绞痛慢性稳定型心绞痛 PCI PCI？什么时候需要血运重建什么时候需要血运重建什么时候需要血运重建什么时候需要血运重建?哪些病人需要血运重建哪些病人需要血运重建哪些病人需要血运重建哪些病人需要血运重建?ACC/AHA/SCAI 2007ACC/AHA/SCAI 2007年年年年PCIPCI指南推荐：指南推荐：指南推荐：指南推荐：ll 病变血管供应大面积心肌病变血管供应大面积心肌病变血管供应大面积心肌病变血管供应大面积心肌 （B B）ll 供应中等面积心肌供应中等面积心肌供应中等面积心肌供应中等面积心肌 （a Ba B）ll 供应小面积心肌或无缺血症状供应小面积心肌或无缺血症状供应小面积心肌或无缺血症状供应小面积心肌或无缺血症状 （C C）慢性稳定型心绞痛慢性稳定型心绞痛慢性稳定型心绞痛慢性稳定型心绞痛 PCIPCI推荐血运重建治疗策略：推荐血运重建治疗策略：推荐血运重建治疗策略：推荐血运重建治疗策略：ll 病变血管供应较大面积心肌的患者病变血管供应较大面积心肌的患者病变血管供应较大面积心肌的患者病变血管供应较大面积心肌的患者ll 症状发作频繁且有加重趋势的患者症状发作频繁且有加重趋势的患者症状发作频繁且有加重趋势的患者症状发作频繁且有加重趋势的患者ll 药物治疗效果欠佳的患者药物治疗效果欠佳的患者药物治疗效果欠佳的患者药物治疗效果欠佳的患者慢性稳定型心绞痛慢性稳定型心绞痛慢性稳定型心绞痛慢性稳定型心绞痛 PCIPCI武汉亚洲心脏病医院武汉亚洲心脏病医院武汉亚洲心脏病医院武汉亚洲心脏病医院ESC Congress Data Releases ESC Congress Data Releases One Year LaterOne Year Later 20072007AHA/ACC/SCAI/ACS/ADA 2007AHA/ACC/SCAI/ACS/ADA 2007学术公告：学术公告：学术公告：学术公告：ll 强调置入强调置入强调置入强调置入DESDES后双重抗血小板治疗至少后双重抗血小板治疗至少后双重抗血小板治疗至少后双重抗血小板治疗至少1212个月个月个月个月ll 接受双重抗血小板治疗的病人，各种择期手术接受双重抗血小板治疗的病人，各种择期手术接受双重抗血小板治疗的病人，各种择期手术接受双重抗血小板治疗的病人，各种择期手术 应推迟应推迟应推迟应推迟1 1年年年年ll 若无法推迟，置入若无法推迟，置入若无法推迟，置入若无法推迟，置入DESDES的病人宜考虑在围手术期的病人宜考虑在围手术期的病人宜考虑在围手术期的病人宜考虑在围手术期 继续服用阿司匹林继续服用阿司匹林继续服用阿司匹林继续服用阿司匹林Intervention 2009Intervention 2009Intervention 2009Intervention 2009Whats Next?Whats Next?