1、DES在复杂病变中的循证医学使用指南,EBM Guidelines for DES,ON LABEL - Safety (stent thrombosis, death and MI) and Efficacy (TLR) OFF LABEL Safety and Efficacy Complex Lesion Subsets,DES: On-Label Use,Safety no increase in death/MI, but small increase in very late stent thrombosis, resulting in uncertainty re: durati
2、on of dual antiplatelet Rx Efficacy marked reduction in TLR cw BMS for all patient and lesion subsets Use Recommendations predominant DES; ? Exceptions = focal lesions/large vessels (non-LAD) 2ry cost-effectiveness issues AND plavix compliance concerns,OFF LABEL Use (DES),More complex and unapproved
3、 indicationsVery small vessels Ultra long lesionsChronic total occlusionsBifurcationsMultivessel diseaseLeft main diseaseIn-stent restenosisSaphenous vein graftsAcute myocardial infarction,DES: Off-Label Use,Safety overall increased events (including death/MI/late ST); most recent data suggests 20%
4、reduction in all-cause mortality cw BMS; continued uncertainty re: duration of dual antiplatelet Rx Efficacy greatest reductions in TLR cw BMS for all patient and lesion subsets Use Recommendations predominant DES; Exceptions = unproven categories (sidebranch in bifurc, complex MVD, UPLM, SVGs, and
5、AMI AND plavix compliance concerns,Dedicated Trials with CYPHER Stent in Specific Patient/Lesion Types,Single, De Novo,Long Lesions,Small Vessels,DM,MVD,ISR,CTO,Bifur- cations,AMI,Direct Stenting,Stairway to Evidence-Based Medicine,RAVEL, SIRIUS, REALITY, ENDEAVOR III, Pache, et al., Petronio, et al
6、., Han., et al.,DIRECT,TYPHOON STRATEGY SESAMI MISSION PROSIT,Park LL Park LL 2,SVELTE, SIRIUS 2.25 SES-SMART ISAR-SMART 3,PORTO I DECODE SCORPIUS DIABETES, CARDIA* ISAR-DIABETES,ACROSS PRISON II,TROPICAL SISR RIBS II INDEED ISAR-DESIRE,ARTS-2,SIRIUS-BIF Nordic PCI,Differing Complexity,* Trials have
7、 not been presented/published,Randomized Controlled Trial (RCT) vs. BMS, Brachytherapy, or POBA NON-RCT RCTs VS. DES,SIRTAX, BASKET, and TAXi (All-Comers), Zhang, et al. SORT-OUT II, Ortlani, et al.,E-SIRIUS, C-SIRIUS,SCANDSTENT, CORPAL, Cervinka, et al. (high-risk),SVG,RRISC DELAYED RRISC,CRF DES E
8、vidence-based Medicine Guidelines Summary 2008,Very Small Vessels,Six-month Binary Restenosis in Small-Vessel SES Trials,Mean RVD, mm 2.37 2.20 2.59 2.65 2.44 2.40 2.04 Mean l/ length, mm 14.8 13.0 14.8 14.5 12.9 17.0 12.1 Diabetes, % 27% 19% 19% 24% 0% 27% 40%,CRF DES Evidence-based Medicine Guidel
9、ines Summary 2008,Very small vessels (smallest Cypher stent is 2.25mm; very little data available),CRF DES Evidence-based Medicine Guidelines Summary 2008,Chronic Total Occlusions,Adverse events at 6 months, %,PRISON-II 200 pts with CTO crossed by wire randomized to BX Velocity vs. Cypher,Suttorp M
10、et al. Circ 2006;114:921-8,FU angiography at 6 months, %,PRISON-II 200 pts with CTO crossed by wire randomized to BX Velocity vs. Cypher,Suttorp M et al. Circ 2006;114:921-8,PRISON II: 36-month Clinical Follow-Up,B.M.Rahel, ACC 2008; Oral Presentation.,PRISON II: Stent Thrombosis in Target Vessel at
11、 36 Month Follow-Up,B.M.Rahel, ACC 2008; Oral Presentation.,CRF DES Evidence-based Medicine Guidelines Summary 2008,- Chronic total occlusions,CRF DES Evidence-based Medicine Guidelines Summary 2008,Bifurcation Disease,Nordic Bifurcation RCT 413 pts at 28 centers in 5 countries with true bifurcation
12、 received Cypher in main vessels and randomized to PTCA vs. Cypher (crush”, “culotte”, “Y” or other techniques) of side branch with final kiss. Clinical FU at 6 months.,Steigen TC et al. ACC 2006,Nordic Bifurcation Study (n=413) Major Endpoints (clinically driven),Steigen TC et al. ACC 2006,Primary
13、endpoint P=0.30,In-hospital MI (%),6 month MACE (%),thrombosis,3x nl,P=0.01,CRF DES Evidence-based Medicine Guidelines Summary 2008,- Routine bifurcation dual DES (T, SKS (V), culotte or crush of sidebranch),CRF DES Evidence-based Medicine Guidelines Summary 2008,Unprotected Left Main Disease,Ostial
14、 and Shaft LM Stenting with DES,(COLOMBO, SERRUYS, PARK; n = 147 pts),Chieffo A et al. Circulation 2007;116:158-162,CABG,1.0,Years after treatment,0.0,2.0,3.0,0,5,Cumulative Incidence (%),15,10,BMS,CABG,1.0,Years after treatment,0.0,2.0,3.0,0,5,Cumulative Incidence (%),15,10,DES,Phase I,Phase II,HR
15、2.58 (1.35-4.94)P=0.004,HR 0.90 (0.56-1.45)P=0.664,MAIN COMPARE LM Registry Death or Q-wave MI (adjusted),SJ Park et al; LM Summit 2007,1.0,Years after treatment,0.0,2.0,3.0,0,10,Cumulative Incidence ( %),30,20,1.0,Years after treatment,0.0,2.0,3.0,0,10,Cumulative Incidence ( %),30,20,CABG,BMS,CABG,
16、DES,HR 5.57 (3.13-9.88)P0.001,HR 5.05 (2.87-8.67)P0.001,MAIN COMPARE LM Registry Repeat Revascularization (adjusted),Phase I,Phase II,SJ Park et al; LM Summit 2007,CRF DES Evidence-based Medicine Guidelines Summary 2008,IIa,- Unprotected Left Main (ostial or shaft; non-complex),Unprotected Left Main
17、 (bifurcation and complex; restricted to research or high risk for surgery),CRF DES Evidence-based Medicine Guidelines Summary 2008,Acute Myocardial Infarction,Drug-eluting Stents in AMI (RCTs),Trial DES BMS N Angio FU 1 EP STRATEGY1 Cypher Bx Vel 175 Yes 8mo D, ReMI, CVA, or TVR TYPHOON2 Cypher Any
18、 700 Yes 12mo TVF SESAMI3 Cypher Bx Vel 320 Yes 12mo restenosis,1. Valgimigli M et al. JAMA 2005;293:2109-2117. 2. Spaulding C et al. NEJM 2006;355:1093-104. 3. Menichelli M. EuroPCR 2006.,Drug-eluting Stents in AMI (RCTs) Mortality,All P=NS,Drug-eluting Stents in AMI (RCTs) Reinfarction,All P=NS,Dr
19、ug-eluting Stents in AMI (RCTs) Stent thrombosis,All P=NS,Drug-eluting Stents in AMI (RCTs) Target lesion revascularization,P=0.023,P=0.006,P0.001,P0.001,CRF DES Evidence-based Medicine Guidelines Summary 2008,Acute myocardial infarction (due to safety concerns),Cordis三代DES设计特点,支架 平台设计 ）,DES设计的基本要素,
20、药物&聚合物,Cordis三代DES设计特点,输送系统 ）,Cypher Select Plus的CYPH2ONIC亲水涂层技术,涂层在SDS 的远端体部之外具体位置在从与导丝交换点到近球囊封点之间的大约9英寸距离(25厘米长),CYPH2ONIC 亲水涂层-使得推送力能顺滑的 从支架近端推送杆传递到末梢头端, Cordis Corporation 2006. Confidential. For Internal Use Only - Not For Distribution.,CYPHER Select+为什么选择改进推送系统？,输送性的因素影响是那些？支架外形支架材质头端长度支架的顺应性还
21、有么？,我们发现：支架推送系统和血管壁之间的摩擦阻力、支架推送系统同导管壁之间的摩擦阻力影响着支架的推送性能这就意味着支架输送系统的顺滑程度对输送性有很大的影响,CYPHER Select 增强了输送系统的特性: CYPH2ONIC 亲水涂层 减小阻力，使支架的推送系统更加顺滑 短而柔韧的头端通过性更好 保持了SELECT 支架的柔韧性设计,摩擦阻力产生在SDS通过导管以及血管弯曲的地方,Friction Zone,Friction Zone,Friction Zone,无亲水涂层的SDS外部,有亲水涂层的Cypher Select Plus的外部,Friction Points,摩擦阻力,光
22、滑性测试,亲水涂层使得Cypher Select Plus 的外杆光滑程度比CYPHER高94%,表面摩擦力,越低越好,对照相关产品的表面摩擦力试验,光滑性测试,三维心脏模型推送实验结果,持久性测试,该测试用来测量随着推送摩擦次数的增加,涂层的损耗程度 测试方法:分别测试第一次和第一百次通过固定好的“硅树脂膜”(模拟导管和血管拐弯处的摩擦阻力)的力量,如果用力相同,证明涂层没有损耗,Plus 的亲水涂层技术,总结 特别为(CYPH2ONIC) CYPHER Select +研制的光滑外涂层 使SDS在摩擦区域的摩擦阻力减少了90%以上,使得推送力更加顺滑的从近端传向远端,而且涂层保持良好的持久
23、性 减少摩擦即意味着省力和易推送 相对于Cypher Select来说,在推送性方面释放了可以更多可以提高的潜能,CYPHER 支架在不同病变和病人亚组中表现的循证医学,Single, De Novo,Long Lesions,Small Vessels,DM,MVD,ISR,CTO,Bifur- cations,AMI,Direct Stenting,Stairway to Evidence-Based Medicine,RAVEL, SIRIUS, REALITY, ENDEAVOR III, Pache, et al., Petronio, et al., Han., et al.,DI
24、RECT,TYPHOON STRATEGY SESAMI MISSION Diaz PROSIT,Park LL Park LL 2,SVELTE, SIRIUS 2.25 SES-SMART ISAR-SMART 3,PORTO I DECODE SCORPIUS DIABETES DESSERT CARDIA* ISAR-DIABETES Korean RCT DECLARE- DIABETES Swedish RCT Italian w/in Pt RCT,ACROSS PRISON II,TROPICAL SISR RIBS II INDEED ISAR-DESIRE,ARTS-2,S
25、IRIUS-BIF Nordic PCI Danish RCT,* Trials have not been presented/published,Randomized Controlled Trial (RCT) vs. BMS, Brachytherapy, or POBA NON-RCT RCTs VS. DES,AND MORE TO COME,SIRTAX, BASKET, and TAXi (All-Comers), Zhang, et al. SORT-OUT II, Ortlani, et al.,E-SIRIUS, C-SIRIUS,SCANDSTENT, CORPAL, Cervinka, et al. (high-risk), Petronio,SVG,RRISC DELAYED RRISC,
