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1、,药物支架的评价与新进展,首都医科大学附属北京安贞医院 刘宇扬 周玉杰,The latest update and evaluation of Drug Eluting Stent,Stent Wars,1977-87,Lasers, rotational, “polishers”,the mid-80s,Toulouse, Jacques Puel & Ulrich Sigwart first stent into a human coronary artery.,1986,Palmaz-Schatz stent was approved for use in the United Stat
2、es.,1994,Close up again (30%),CYPHER APRIL 2003,TAXUS MARCH 2004,ENDEAVOR APRIL 2005/2008,XIENCE 2006,Bioresotable CoStart, Custom NX, Nobbori,EPCs-Genous,STENT WARS- evolution of DES,2003,2004,2005,Cypher approval,Taxus approval,U.S. penetration of DES (% of PCIs using at least one DES),DTCA FOR DE
3、S,Thrombosis,从ESC“Fire Storm” 到TCT“Crossfire”,Cypher&Taxus meta-analysis-ST,Taxus-, , , , , SIRIUS,E-SIRIUS, C-SIRUS,Ajay J. Kirtane, M.D., S.M.Gregg W. Stone, M.D.,Comprehensive Meta-Analysis of DES vs. BMS Randomized Trials and Registries,Presented at ACC 2008,All-Cause Mortality: All RCTs,8,867 p
4、atients, 21 trials,Favors BMS,Estimate (95% CI),Weight (%),0.97 (0.81,1.15) 0.97 (0.81,1.15), p=0.72,Random Effects *Fixed Effects (I2=0.0%),Favors DES,Mean f/u 2.9 yrs,Ajay J. Kirtane and Gregg W. Stone, 2008,All-Cause Mortality: RCTs (On-Label),4,818 patients, 10 trials,Favors DES,Favors BMS,Estim
5、ate (95% CI),Weight (%),1.05 (0.84,1.30) 1.05 (0.84,1.30), p=0.69,Random Effects *Fixed Effects (I2=0.0%),Mean f/u 4.0 yrs,Ajay J. Kirtane and Gregg W. Stone, 2008,All-Cause Mortality: RCTs (Off-Label),4,049 patients, 12 trials,Favors DES,Favors BMS,Estimate (95% CI),Weight (%),0.84 (0.62,1.13) 0.84
6、 (0.62,1.13), p=0.24,Random Effects *Fixed Effects (I2=0.0%),Mean f/u 1.5 yrs,Ajay J. Kirtane and Gregg W. Stone, 2008,All-Cause Mortality: All Registries,161,232 patients, 28 registries,Favors BMS,Estimate (95% CI),Weight (%),0.80 (0.72,0.88), p0.001 0.83 (0.79,0.86),Favors DES,*Random Effects (I2=
7、70.1%) Fixed Effects,Mean f/u 2.5 yrs,Ajay J. Kirtane and Gregg W. Stone, 2008,All-Cause Mortality: Adjusted Registries,134,534 patients, 18 registries,Favors BMS,Estimate (95% CI),Weight (%),0.80 (0.72,0.90), p0.001 0.82 (0.79,0.86),Favors DES,*Random Effects (I2=76.6%) Fixed Effects,Mean f/u 2.7 y
8、rs,Ajay J. Kirtane and Gregg W. Stone, 2008,MI: RCTs (Off Label),4,532 patients, 12 trials,Estimate (95% CI),Weight (%),Favors DES,Favors BMS,0.77 (0.54,1.10) 0.83 (0.62,1.10), p=0.19,Random Effects *Fixed Effects (I2=25.5%),Ajay J. Kirtane and Gregg W. Stone, 2008,Mean f/u 1.5 yrs,TVR: All RCTs,7,2
9、91 patients, 16 trials,Favors DES,Favors BMS,Estimate (95% CI),Weight (%),0.45 (0.37,0.54), p0.001 0.51 (0.45,0.57),*Random Effects (I2=53.2%) Fixed Effects,Mean f/u 3.2 yrs,TVR: All Registries,73,819 patients, 17 registries,Favors DES,Favors BMS,Estimate (95% CI),Weight (%),0.53 (0.47,0.61), p0.001
10、 0.57 (0.54,0.60),*Random Effects (I2=71.2%) Fixed Effects,Mean f/u 2.2 yrs,Ajay J. Kirtane and Gregg W. Stone, 2008,All-Cause Mortality: Adjusted Registries,134,534 patients, 18 registries,Favors BMS,Estimate (95% CI),Weight (%),0.80 (0.72,0.90), p0.001 0.82 (0.79,0.86),Favors DES,*Random Effects (
11、I2=76.6%) Fixed Effects,Mean f/u 2.7 yrs,Ajay J. Kirtane and Gregg W. Stone, 2008,Conclusions(1),In 22 RCTs in which 9,470 pts were randomized to DES or BMS and followed for 1 yr, DES resulted in: Non significant 3% and 6% reductions in mortality and MI respectivelyA highly significant 55% reduction
12、 in TVR In 30 registries in which 174,302 pts were treated with either DES or BMS (non-randomized) and followed for 1 yr, DES was associated with:A highly significant 20% reduction in mortalityA significant 11% reduction in MIA highly significant 47% reduction in TVR,Conclusions (2),The favorable re
13、sults of DES from the RCT and registry analysis populations were robust and consistent for both on-label and off-label use, and for clinical f/u extending to 3-4 years These findings, derived from more than 180,000 pts treated in 52 studies, strongly suggest that DES are safe for both on-label and o
14、ff-label use, and have comparable efficacy in both RCTs and in the “real-world”,SCARR Study,SCARR- REGISTRY Stent thrombosis,Time (years),2,1,0,Cumulative risk of stent thrombosis %,2,1,0,DES n=21 717,BMS n=20 058,Stent typ,Total cohort N=41 775 stents,0.5% per year,Unadjusted,Drug eluting stent- 3
15、elements,better DES- backbone,Major changeThin stent struts Stent geometry homogenous drug distributionstent fracture Special designed stent for complex lesions,Profile Flexibility Deliverability Less injury,Evolution of stent material,316L stainless steel,Nickel-titan alloy,Nickel-titan alloy With platinum,Cobalt chromium alloy,Magnesium-alloy absorbale,More flexible, thin, radial strength,NEW STENT PLATFORM=PERSS,Better DES- drug related issues,VOICE OF TCT 2008,ISAR-TEST 2,ISAR-TEST 2,Drug carrier system,Yoritaka Otsuka, etal. The Journal of Invasive Cardiology 04/19/2007,
