冠心病介入治疗再认识朱国英.ppt

武汉亚洲心脏病医院 朱国英,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,Event free survival My rosy prophecy,Andreas Gruentzigs Lecture,ESC 2000 Amsterdam,Event free survival My rosy prophecy,Andreas Gruentzigs Lecture,ESC 2000 Amsterdam,Current Trials of CABG vs. DES,SYNTAX FREEDOM COMBAT,SYNTAX Trial Design,SYNTAX 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PCI,SYNTAX是多支血管病变治疗策略真实世界的研究,SYNTAX Eligible Patients,Patient Characteristics ( 1 ) Randomized Cohort,Patient Characteristics ( 2 ) Randomized Cohort,All Cause Death to 12 Months,Myocardial infarction to 12 Months,All Cause Death / CVA / MI to 12 Months,Symptomatic Graft Occlusion Stent Thrombosis to 12 Months,MACCE to 12 Months,Repeat Revascularization to 12 Months,CVA to 12 Months,12 Month LM Subgroup MACCE Rates,12 Month LM Subgroup MACCE Rates,Outcome according to Diabetic Status,Conclusions,Patient Profiling,There is 3-vessel disease and 3-vessel disease ,研究结果：12月 MACE- SYNTAX SCORE,Patrick 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,SYNTAX 的意义,SYNTAX 的意义,SYNTAX,SYNTAX,STEMI 的血运重建方式,ST段抬高心肌梗死,溶栓,直接PCI,溶栓后PCI,CABG,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=0.0002,P=0.0003,P0.0001,P0.0001,P0.0001,P=0.0004,P=0.032,P0.0001,Death,Death, no SHOCK data,ReMI,Rec. Isch,Total Stroke,Hem. Stroke,Major Bleed,Death MI CVA,Fibrinolysis,(%) Events,DES 能否常规用于直接 PCI ？,Harmonizing Outcomes with Revascularization and Stents in AMI,3602 pts with STEMI with symptom onset 12 hours,Clinical FU at 30 days, 6 months, 1 year, and then yearly through 5 years; angio FU at 13 months,Stent Randomization Hypotheses,In patients with STEMI undergoing 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; and Safe, with non-inferior rates of the composite measure of death, reinfarction, stent thrombosis or stroke at 1-year,Horizons Enrollment - Centers,USA (57),(1) Spain,(6) UK,(2) Norway,Poland (9),Germany (16),Austria (5),(3) Netherlands,Italy (2),Argentina (12),Israel (10),3,602 pts randomized at 123 centers in 11 countries between March 25th, 2005 and May 7th, 2007,Harmonizing Outcomes with Revascularization and Stents in AMI,3006 pts eligible for stent rand.,Primary Medical Rx 193 Primary CABG 62 Deferred PCI 2 Index PCI, not eligible - PTCA only 119 - Stented 220,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 (%),0,1,2,3,4,5,6,7,8,9,10,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, 0.83 P=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 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, 0.89 P=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,0,1,2,3,4,5,6,7,8,9,10,11,12,2257,2115,2086,2057,1856,749,697,683,672,619,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, 1.36 PNI=0.01 PSup=0.92,* Safety MACE = death, reinfarction, stroke, or stent thrombosis,One-Year All-Cause Mortality,Mortality (%),0,1,2,3,4,5,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 0.64,1.55 P=0.98,One-Year Death or Reinfarction,Stent Thrombosis (ARC Definite or Probable),Angiographic Follow-up,TAXUS DES N=1348,EXPRESS BMS N=452,Randomized,Eligible,N=1308,N=441,1800 consecutive eligible pts assigned to 13 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 days,40,11, Died before angio FU ,N=942 (72.0%),N=307 (69.6%),Completed Angio FU,366,134, Angio FU not performed , Not received/analyzable Out of window ,28 3,14 0,N=911,N=293,Analyzed, Lesions ,1081,332,Binary Analysis Segment Restenosis at 13 Months Patient and Lesion Level Analysis*,RR 95%CI = 0.44 0.33, 0.57 P0.0001,* ITT: Includes all stent randomized lesions, whether or not a stent was implanted, and whether or not non study stents were placed * Any lesion with restenosis per pt restenosis,RR 95%CI = 0.44 0.33, 0.57 P0.0001,Major 2 endpoint,Angiographic Late Loss at 13 Month Lesions with Stents Implanted,P0.0001,P0.0001, 0.42, 0.54, 0.64, 0.70,P = 0.18,P = 0.07, 0.56, 0.64, 0.47, 0.50,Binary Angiographic Restenosis at 13 Months Lesions with Stents Implanted,RR 95%CI = 0.42 0.32, 0.54 P0.0001,RR 95%CI = 0.39 0.29, 0.52 P0.0001,P = 0.13,P = 0.42,Conclusions,In this large-scale, prospective, randomized trial of pts with STEMI undergoing primary stenting, 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 restenosis Non inferior rates of the primary composite safety endpoint of all cause death, reinfarction, stent thrombosis or str