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1、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. 2007;28:2706-2713. 2. Pittl C, et al. Eur Heart J. 2006;27:650 (abstract suppl). 3. Di Lorenzo E, et al. ACC Scientific Sessions 2005. Presentation 2303. 4. HAAMU-STENT trial. Available at wwwcardiosourcecom/pops/trialSumasp?trialID=1492. Ac
2、cessed 5 March 2007. 5. van der Hoeven BL, et al. J Am Coll Cardiol. 2008;51(6):618-26. 6. Laarman GJ et al. N Engl J Med. 2006; 355:1105-13. 7. Menichelli M, et al. J Am Coll Cardiol. 2007;49(19):1924-30. 8. Valgimigli M, et al. JAMA. 2005;293(17):2109-17. 9. Spaulding C, et al. N Engl J Med. 2006;
3、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.
4、 2007;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-STE
5、NT; MISSION; PASSION; SESAMI; STRATEGY; TYPHOON,Kastrati A, et al. Eur Heart J. 2007;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; S
6、TRATEGY; TYPHOON,HR: 0.80 (95% CI, 0.46-1.39) p=0.43,Kastrati A, et al. Eur Heart J 2007;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,Primar
7、y 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. 2006;355:1105-13.,MACE (%),10,0,120,240,360,5,BMS,Laarman, GJ et al. N Engl J Med. 2006;355:1105-13.,Days,PRIMARY ENDPOINT NOT ACHIEVED HR=
8、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 a
9、t ESC 2007.,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 Investigator
10、s 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 2006; 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 (3597pati
11、ents),% 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 targ
12、et 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 Myoc
13、ardial 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, s
14、tent 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
15、 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: tar
16、get 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
17、/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 2008,22,A Randomized，Multi-Center，Singl
18、e-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 2008,23,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
19、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 beh
20、ind 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
21、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 Europ
22、e, 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.,F
23、irst Patient Enrolled March 19, 2008 Enrollment Completed October 17, 2008,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 protoco
24、l definition) including follow up to 5 years TLF/TVF/MACE and individual components including follow up to 5 years Stent malapposition and % volume obstruction (IVUS) Quality of life at baseline, 30 days, 6months and 1 year,Specified subgroup analyses: Patients with diabetes mellitus,0.31,0.46,N=180
25、,N=162,64%,P=0.075,2/180,13/162,7/180,14/162,86%,55%,Superiority of the NEVO stent over the TAXUS Libert stents was reached with a highly significant difference (P0.001) between stents (6- month late loss 0.13 0.31 vs. 0.36 0.46mm) No stent thrombosis were observed in the NEVO group while 2 late thromboses despite dual APT occurred in the TAXUS Libert group While not powered for clinical endpoints, in this study the rates of death, MI, and revascularization as well as the composite endpoints of TLF, TVF, and MACE all favored NEVO over TAXUS Libert,