ami介入治疗时支架选择策略.ppt

中国医学科学院 阜外心血管病医院 陈纪林 教授,1. Kastrati A, et al. Eur Heart J. 2019;28:2706-2713. 2. Pittl C, et al. Eur Heart J. 2019;27:650 (abstract suppl). 3. Di Lorenzo E, et al. ACC Scientific Sessions 2019. Presentation 2303. 4. HAAMU-STENT trial. Available at wwwcardiosourcecom/pops/trialSumasp?trialID=1492. Accessed 5 March 2019. 5. van der Hoeven BL, et al. J Am Coll Cardiol. 2019;51(6):618-26. 6. Laarman GJ et al. N Engl J Med. 2019; 355:1105-13. 7. Menichelli M, et al. J Am Coll Cardiol. 2019;49(19):1924-30. 8. Valgimigli M, et al. JAMA. 2019;293(17):2109-17. 9. Spaulding C, et al. N Engl J Med. 2019;355(11):1093-104.,20,10,5,Probability of reintervention (%),15,11,12,Months after randomization,10,9,8,7,6,5,4,3,2,1,0,2786 patients,HR: 0.38 (95% CI, 0.290.50) p 0.001,*Trials included were: BASKET; di Lorenzo; HAAMU-STENT; MISSION; PASSION; SESAMI; STRATEGY; TYPHOON,Kastrati A, et al. Eur Heart J. 2019;28:2706-2713.,10,Probability of death (%),8,4,6,2,0,HR: 0.76 (95% CI, 0.53-1.10) p=0.14,Months after randomisation,10,8,4,6,2,0,HR: 0.72 (95% CI, 0.48-1.08) p=0.11,Months after randomisation,Probability of recurrent myocardial infarction (%),*Trials included were: BASKET; di Lorenzo; HAAMU-STENT; MISSION; PASSION; SESAMI; STRATEGY; TYPHOON,Kastrati A, et al. Eur Heart J. 2019;28:2706-2713.,5,4,2,1,0,Probability of stent thrombosis (%),3,0,1,2,4,8,11,12,Months after randomisation,10,6,9,7,5,3,2786 patients,*Trials included were: BASKET; di Lorenzo; HAAMU-STENT; MISSION; PASSION; SESAMI; STRATEGY; TYPHOON,HR: 0.80 (95% CI, 0.46-1.39) p=0.43,Kastrati A, et al. Eur Heart J 2019;28:2706-2713.,Randomisation 1:1,BMS (n=310),Taxus Express2 or Liberte Stent (n=309),STEMI patients with chest pain 20mn and ST-elevation in 2 contiguous leads; infarct related artery with a de novo lesion,Primary Endpoint: Composite of death, recurrent MI, or target lesion (within 5 mm of stent edges) revascularization (TLR) at one year,Laarman, GJ et al. N Engl J Med. 2019;355:1105-13.,MACE (%),10,0,120,240,360,5,BMS,Laarman, GJ et al. N Engl J Med. 2019;355:1105-13.,Days,PRIMARY ENDPOINT NOT ACHIEVED HR=0.68 (0.41-1.10) p=0.12,8.7,12.6,No prespecified angiographic F/U,Dual APT recommended for 6 months (Clopidogrel: Median Duration of 9 months),*Cardiac Death, MI, or TLR,p =0.12,p =0.32,p=0.09,OR 0.70 (95% CI: 0.45-1.09),OR 0.78 (95% CI: 0.41-1.44),OR 0.60 (95% CI: 0.34-1.09),Dirksen MT. Presented at ESC 2019.,15.4,7.2,9.9,11.1,5.6,6.0,0,5,10,15,20,MACE,Cardiac Death,TLR,% of Patients,BMS,SES in AMI Typhoon Trial To Assess The Use of the CYPHER Sirolimus-eluting Stent (SES) in Acute Myocardial Infarction Patients Treated With Balloon Angioplasty,Christian Spaulding for the TYPHOON Investigators PCR 2009,SES in AMI Typhoon study design,715 名首次发生AMI后12小时内行急诊PCI手术的患者,1:1随机化,Spaulding C., et al., New Engl J Med 2019; 355:1093-104.,1 withdrew consent post-PCI,2 withdrew consent post-PCI,CYPHER or CYPHER Select (355 patients),研究终点: 1年的TVF, TVF确定标准: 缺血症状引起的TVR, 再发心梗, 靶血管相关的心源性死亡,裸金属支架 (3597patients),% 占患者总数的百分比,P 0.001,P 0.0001,P = NS,P 0.001,P = 0.004,P = NS,MACE: major adverse cardiac events defined as all-cause death, re-MI or TLR. TLR: target lesion revascularization. TVR: target vessel revascularization. TVF: target vessel failure defined as ischemia-driven TVR, recurrent MI, or target vessel-related cardiac death MI: myocardial infarction (all). ST: stent thrombosis (per protocol),P = NS,主要终点 TVF,MACE,TLR,TVR,MI,ST,DEATH,HORIZON 2年和TYPHOON 4年结果,A Prospective, Randomized Comparison of Paclitaxel-eluting TAXUS Stents vs. Bare Metal Stents During Primary Angioplasty in Acute Myocardial Infarction Gregg W. Stone MD For the HORIZONS-AMI Investigators,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,1) Ischemia-driven TLR*,2) Composite Safety MACE = All cause death, re-infarction, stent thrombosis (ARC definite or probable)*, or stroke,and,* Related to randomized stent lesions (whether study or non study stents were implanted);,Major Secondary Endpoint (at 13 Months),Binary angiographic restenosis,* In randomized stent lesions with 1 stent implanted (whether study or non study stents),1年结果：TAXUS PES与Express BMS减少临床和造影再狭窄率，而死亡、再发心结梗死和支架内血栓形成发生率相似。 MACE：死亡、心肌梗死、卒中或支架内血栓形成,心源性死亡,全因死亡,缺血所致TVR,次要终点,MACE,缺血所致TLR,再次心肌梗死,主要终点,支架内血栓 （肯定和极可能的）,2-year outcomes,% of Patients,P =0.005,P = 0.23,P =0.013,P = 0.83,MI: myocardial infarction, TLR: target lesion revascularization, TVR: target vessel revascularisation, Non- hierarchical events,P =0.37,10/251,16/250,8/251,12/250,12/251,10/250,18/251,38/250,24/251,43/250,Academic Research Consortium / Dublin-Defined Events,53%,44%,13 (5.2%),9 (3.6%),9 (3.6%),6 (2.4%),3 (1.2%),6 (2.4%),1 (0.4%),21 (8.4%),Stent Thrombosis (%),P = 0.16,ARC/Dublin definitions. Hierarchical events,Typhoon 研究小结,TYPHOON 4 yr FU,TYPHOON 研究表明: 同BMS相比 Cypher支架明显的降低了TVF, TVR, TLR的发生率 在全因死亡率, 心源性死亡率, 心梗发生率和支架内血栓发生率方面, 二者没有差别 在心肌梗死患者中应用, Cypher支架降低了再次血运重建的几率, 并且没有晚期追赶的现象; 长期的随访同时表明, Cypher支架的安全性同样持久保持, Cordis Corporation 2019,22,A Randomized，Multi-Center，Single-Blind Comparison of NEVO Sirolimus-Eluting Coronary Stent versus the TAXUS Libert Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions,PI: Drs. Christian Spaulding, Alexandre Abizaid and John Ormiston, Cordis Corporation 2019,23,NEVO是Cordis 的下一代的药物涂层支架,药物沿用经典的雷帕霉素，支架平台设计采用独特的RES(药物释放槽)技术,将药物/聚合物同血管壁的接触降低到更小; 迄今真正的可吸收聚合物支架, 其药物释放槽中的聚合物可在3-4个月后完全降解.,RES技术：全新的设计 (Reservoir, 药物释放槽),Minimize tissue/polymer contact while protecting the drug/polymer from mechanical damage,Complete elution of the drug and resorbtion of the polymer from the reservoirs over time leave behind a bare metal stent,A matrix of drug and polymer is loaded on the reservoirs,Objective: To demonstrate non-inferiority(and, if positive, superiority) of the NEVO Stent compared with the TAXUS Libert stent for the primary endpoint of 6-months in-stent late loss,Major Inclusion Criteria: Single De nove lesions in native coronary arteries Lesion Length 28mm 2.5mm-3.5mm in diameter,Major Exclusion Criteria: Acute myocardial infarction Ostial lesions Unprotected left main stem lesions,Single De Novo Native Coronary Artery Lesion 28 mm in a 2.5-3.5mm diameter vessel,388 patients 40 sites in Europe, South America, Australia, & New Zealand,NEVO Sirolimus- Eluting Stent (N=202),TAXUS Libert Paclitaxel-Eluting Stent (N=192),1:1 Randomization,Primary Endpoint: 6-Month In-Stent Late Loss IVUS in a subset of patients,30 Day,6 Mo.,1 Yr.,2 Yr.,3 Yr.,4 Yr.,Clinical/MACE,Angio/IVUS,5 Yr.,9 Mo.,3 Mo.,First Patient Enrolled March 19, 2019 Enrollment Completed October 17, 2019,Primary Endpoint: 6-months in-stent late lumen loss (Angiographic),Secondary Endpoints: In-stent/in-segment binary restenosis, %diameter stenosis and MLD Device, Lesion, and procedure success Stent Thrombosis (ARC and protocol definition) including follow up to 5 years TLF/TVF/MACE and individual compon