冠心病介入治疗再认识-课件

1、武汉亚洲心脏病医院朱国英年冠心病介入治疗再认识2009武汉亚洲心脏病医院年冠心病介入治疗再认识2009 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（PTCA）时代 多个临床试验结果有利于CABG CABG完全血运重建率高 PCI再次血运重建率高单纯球囊扩张（PTCA）时代 多个临床试验结果有利于CAB1009080706050060120180240300360Days%Death / MI / CABG / Re-PTCACABRI: CABG (91%)CABRI: PTCA (59%)32%14%Event free survival My rosy prophecyAR

2、TS2: Eluting STENT (95%)ARTS2: CABG (90%)CABRI : 1994ARTS : 1999ARTS 2: 2003, FREEDOMARTS: CABG (89%)ARTS: STENT (75%)- 5%Andreas Gruentzigs Lecture,ESC 2000 Amsterdam1009080706050060120180240300361009080706050060120180240300360Days%Death / MI / CABG / Re-PTCACABRI: CABG (91%)CABRI: PTCA (59%)32%14%

3、Event free survival My rosy prophecyARTS2: Eluting STENT (95%)ARTS2: CABG (90%)CABRI : 1994ARTS : 1999ARTS 2: 2003, FREEDOMARTS: CABG (89%)ARTS: STENT (75%)- 5%Andreas Gruentzigs Lecture,ESC 2000 Amsterdam100908070605006012018024030036Current Trials of CABG vs. DESSYNTAX FREEDOMCOMBATCurrent Trials

4、of CABG vs. DES冠心病介入治疗再认识_课件冠心病介入治疗再认识_课件冠心病介入治疗再认识_课件SYNTAX Trial DesignSYNTAX Trial DesignSYNTAX 是多支血管血运重建的里程碑研究 第一个随机、对照临床研究 设计基础： 回顾分析了 2003 2004 年 104家医疗中心的 血运重建（CABG或PCI） 12,072 例患者: 1/3为左主干，2/3为三支病变 治疗策略：2/3 选择CABG，1/3 选择PCISYNTAX是多支血管病变治疗策略真实世界的研究SYNTAX 是多支血管血运重建的里程碑研究 第一个随机、对SYNTAX Eligible

5、 PatientsSYNTAX Eligible PatientsPatient Characteristics ( 1 )Randomized CohortPatient Characteristics ( 1 )Patient Characteristics ( 2 )Randomized CohortPatient Characteristics ( 2 )All Cause Death to 12 MonthsAll Cause Death to 12 MonthsMyocardial infarction to 12 MonthsMyocardial infarction to 12

6、 MoAll Cause Death / CVA / MI to 12 MonthsAll Cause Death / CVA / MI tSymptomatic Graft Occlusion Stent Thrombosis to 12 MonthsSymptomatic Graft Occlusion MACCE to 12 MonthsMACCE to 12 MonthsRepeat Revascularization to 12 MonthsRepeat Revascularization to 12CVA to 12 MonthsCVA to 12 Months12 Month L

7、M Subgroup MACCE Rates12 Month LM Subgroup MACCE Rat12 Month LM Subgroup MACCE Rates12 Month LM Subgroup MACCE RatOutcome according to Diabetic StatusOutcome according to Diabetic ConclusionsConclusionsPatient ProfilingPatient ProfilingThere is 3-vessel disease and 3-vessel disease There is 3-vessel

8、 disease 研究结果：12月 MACE- SYNTAX SCORE研究结果：12月 MACE- SYNTAX SCOREPatrick W. Serruys： 对于合并左主干冠心病患者： DES 和 CABG 的有效性和安全性相近似 对于采用SYNTAX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： DES是更为合理的治疗选择 对于高计分（33分）组左主干合并多支病变患者： CABG是较为合理的治疗选择Patrick W. Serruys： 对于合并左主干冠心SYNTAX 的意义 Patrick Serruys 评论： 首次比较了DES和CABG对复杂、疑难病

9、变 患者的影响 PCI和CABG 对主要终点事件的影响未分胜负 结果显示PCI和CABG都能改善预后SYNTAX 的意义 Patrick Serruys 评论： Petr Widimsky 评论： 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 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 承担再次血管重建的风险 SYNTAX 的意义 Petr Widimsky 评论：SYNTAX 的意义SYNTAXSYNTAXSYNTAXSYNTAX冠心病介入治疗再认识_课件STEMI 的血运重建方式 ST段抬高心肌梗死溶栓直接PCI溶栓后PCICABGSTEMI 的血

10、运重建方式 ST段抬高心肌梗死溶栓直接P直接 PCI 和溶栓疗法的比较 23 个随机研究的汇萃分析 （n = 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 (%) EventsDES 能否常规用于直接 PCI ？直接 PCI 和溶栓疗法的

11、比较 23 个随机Harmonizing Outcomes with Revascularization and Stents in AMI3602 pts with STEMI with symptom onset 12 hoursEmergent angiography, followed by triage toPrimary PCICABGMedical RxUFH + GP IIb/IIIa inhibitor(abciximab or eptifibatide)Bivalirudin monotherapy( provisional GP IIb/IIIa)Aspirin, thi

12、enopyridine R 1:13000 pts eligible for stent randomization R 3:1Bare metal EXPRESS stentPaclitaxel-eluting TAXUS stentClinical FU at 30 days, 6 months, 1 year, and thenyearly through 5 years; angio FU at 13 monthsHarmonizing Outcomes with RevaStent Randomization HypothesesIn patients with STEMI unde

13、rgoing primary PCI, the use of paclitaxel-eluting TAXUS stents rather than bare metal EXPRESS stents will be:Efficacious, as evidenced by reduced rates of ischemia-driven target lesion revascularization at 1-year and angiographic binary restenosis at 13 months; andSafe, with non-inferior rates of th

14、e composite measure of death, reinfarction, stent thrombosis or stroke at 1-yearStent Randomization HypothesesHorizons Enrollment - CentersUSA (57)(1) Spain(6) UK (2) NorwayPoland (9)Germany (16)Austria (5)(3) NetherlandsItaly (2)Argentina (12)Israel (10)3,602 pts randomized at 123 centers in 11 cou

15、ntriesbetween March 25th, 2005 and May 7th, 2007Horizons Enrollment - CentersUTAXUS DESN=2257EXPRESS BMSN=749Randomized1 year FUN=2186(96.9%)N=715(95.5%) Withdrew Lost to FU 1853727 R 3:1Harmonizing Outcomes with Revascularization and Stents in AMI3006 pts eligible for stent rand.Primary Medical Rx1

16、93Primary CABG 62Deferred PCI 2Index PCI, not eligible - PTCA only119 - Stented220UFH + GPI (n=1802)Bivalirudin (n=1800) R 1:13602 pts with STEMI93.1% of all stented pts were randomizedTAXUS DESEXPRESS BMSRandomized22572132209820691868749697675658603Number at riskTAXUS DESEXPRESS BMSPrimary Efficacy

17、 Endpoint: Ischemic TLRIschemic TLR (%)012345678910Time in Months01234567891011127.5%4.5%Diff 95%CI =-3.0% -5.1, -0.9 HR 95%CI =0.59 0.43, 0.83P=0.002TAXUS DES (n=2257)EXPRESS BMS (n=749)225721322098206918687496976756Ischemic TVR (%)012345678910Time in Months01234567891011122257211920782045184874969

18、5669650598Number at riskTAXUS DESEXPRESS 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)EXPRESS BMS (n=749)Secondary Efficacy Endpoint: Ischemic TVRIschemic TVR (%)012345678910TiPrimary Safety Endpoint: Safety MACE*Safety MACE (%)012345678910Time in Months0

19、12345678910111222572115208620571856749697683672619Number at riskTAXUS DESEXPRESS BMSTAXUS 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 thrombosisPrimary Safety Endpoint: SafetOne-Year

20、 All-Cause MortalityMortality (%)012345Time in Months012345678910111222572180216121471949749716712702648Number at riskTAXUS DESEXPRESS BMSTAXUS DES (n=2257)EXPRESS BMS (n=749)3.5%3.5%HR 95%CI =0.99 0.64,1.55P=0.98One-Year All-Cause MortalityMoOne-Year Death or ReinfarctionDeath or MI (%)012345678Tim

21、e in Months012345678910111222572140211020831882749703689678625Number at riskTAXUS DESEXPRESS BMSTAXUS DES (n=2257)EXPRESS BMS (n=749)7.0%6.8%HR 95%CI =0.97 0.70,1.32P=0.83One-Year Death or ReinfarctionStent Thrombosis (ARC Definite or Probable)22382122209820781884744701694683629Number at riskTAXUS D

22、ESEXPRESS BMSStent Thrombosis (%)01234Time in Months0123456789101112TAXUS DES (n=2238)EXPRESS BMS (n=744)3.4%3.1%HR 95%CI =0.92 0.58,1.45P=0.72Stent Thrombosis (ARC DefiniteAngiographic Follow-upTAXUS DESN=1348EXPRESS BMSN=452RandomizedEligibleN=1308N=4411800 consecutive eligible pts assigned to 13

23、month angiographic FU* Randomized in stent arm; stent procedure successful (DS 10%, TIMI-3 flow, NHLBI type A peri-stent dissection); no stent thrombosis or CABG w/i 30 days4011 Died before angio FU N=942(72.0%)N=307(69.6%)CompletedAngio FU366134 Angio FU not performed Not received/analyzable Out of

24、 window 283140N=911N=293Analyzed Lesions 1081332Angiographic Follow-upTAXUS DEBinary Analysis Segment Restenosis at 13 MonthsPatient and Lesion Level Analysis*RR 95%CI = 0.44 0.33, 0.57P0.0001* ITT: Includes all stent randomized lesions, whether or not a stent was implanted, and whether or not non s

25、tudy stents were placed* Any lesion with restenosis per pt restenosisRR 95%CI = 0.44 0.33, 0.57P0.0001Major 2 endpointBinary Analysis Segment RestenAngiographic Late Loss at 13 Month Lesions with Stents ImplantedP0.0001P0.0001 0.42 0.54 0.64 0.70 P = 0.18P = 0.07 0.56 0.64 0.47 0.50 Angiographic Lat

26、e Loss at 13 MBinary Angiographic Restenosis at 13 MonthsLesions with Stents ImplantedRR 95%CI = 0.42 0.32, 0.54P0.0001RR 95%CI = 0.39 0.29, 0.52P0.0001P = 0.13P = 0.42Binary Angiographic RestenosisConclusionsIn this large-scale, prospective, randomized trial of pts with STEMI undergoing primary ste

27、nting, the implantation of paclitaxel-eluting TAXUS stents compared to bare metal EXPRESS stents resulted in:A significant 41% reduction in the 1-year primary efficacy endpoint of ischemia-driven TLR, and a significant 56% reduction in the 13 month major secondary efficacy endpoint of binary restenosisNon inferior rates of the primary composite safety endpoint of all cause death, reinfar