DES在复杂病变中的循证医学使用指南PPT课件

1、第1页/共44页第2页/共44页第3页/共44页第4页/共44页Safety overall increased events (including death/MI/late ST); most recent data suggests 20% 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 subset

2、sUse Recommendations predominant DES; Exceptions = unproven categories (sidebranch in bifurc, complex MVD, UPLM, SVGs, and AMI AND plavix compliance concerns第5页/共44页Dedicated Trials with CYPHER Stent in Specific Patient/Lesion TypesSingle, De NovoLongLesionsSmallVesselsDMMVDISRCTOBifur-cationsAMIDir

3、ectStentingStairway to Evidence-Based MedicineRAVEL, SIRIUS, REALITY, ENDEAVOR III, Pache, et al., Petronio, et al., Han., et al.DIRECTTYPHOONSTRATEGYSESAMIMISSIONPROSITPark LLPark LL 2SVELTE,SIRIUS 2.25SES-SMARTISAR-SMART 3PORTO IDECODESCORPIUSDIABETES, CARDIA*ISAR-DIABETESACROSSPRISON IITROPICALSI

4、SRRIBS IIINDEEDISAR-DESIREARTS-2SIRIUS-BIFNordic PCIDiffering Complexity* Trials have not been presented/publishedRandomized Controlled Trial (RCT) vs. BMS, Brachytherapy, or POBANON-RCTRCTs VS. DESSIRTAX, BASKET, and TAXi (All-Comers), Zhang, et al. SORT-OUT II, Ortlani, et al.,E-SIRIUS, C-SIRIUSSC

5、ANDSTENT, CORPAL, Cervinka, et al. (high-risk)SVGRRISCDELAYED RRISC第6页/共44页CRF DES Evidence-based MedicineGuidelines Summary2008第7页/共44页6.39.85.82.311.49.616.90369121518SVELTESES-SMARTE-SIRIUSC-SIRIUSISAR-SMARTREALITYSIRIUS 2.25Binary restenosis at 6 months, %Six-month Binary Restenosis in Small-Ves

6、sel SES Trials Mean RVD, mm 2.37 2.20 2.59 2.65 2.44 2.40 2.04Mean 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% 第8页/共44页CRF DES Evidence-based MedicineGuidelines Summary2008第9页/共44页CRF DES Evidence-based MedicineGuidelines Summary2008第10页/共44页PRISON-II200 p

7、ts with CTO crossed by wire randomized to BX Velocity vs. Cypher第11页/共44页PRISON-II200 pts with CTO crossed by wire randomized to BX Velocity vs. Cypher第12页/共44页PRISON II: 36-month Clinical Follow-Up01020304050Clinical event (%)SES (n=100)BMS (n=100)455152535DeathMITLRp=NSp=NSp0.001TVRTVFMACEp=0.002p

8、0.001p360 days2 (possible)3 (definite)Total2 (2%)5 (5%)第14页/共44页CRF DES Evidence-based MedicineGuidelines Summary2008第15页/共44页CRF DES Evidence-based MedicineGuidelines Summary2008第16页/共44页Nordic Bifurcation RCT413 pts at 28 centers in 5 countries with true bifurcation received Cypher in main vessels

9、 and randomized to PTCA vs. Cypher (crush”, “culotte”, “Y” or other techniques) of side branch with final kiss. Clinical FU at 6 months.N=206N=207MV stented (%)10098.5NSSB stented (%)4.395.10.001Kissing balloon (%)32740.001Tx successful (%)*9795NS第17页/共44页1.01.41.01.41.44.01.51.02.02.54.8002468Death

10、MIStentTLRTVRMACENordic Bifurcation Study (n=413)Major Endpoints (clinically driven)8.018.005101520CKMBP=0.01第18页/共44页CRF DES Evidence-based MedicineGuidelines Summary2008第19页/共44页CRF DES Evidence-based MedicineGuidelines Summary2008第20页/共44页 Ostial and Shaft LM Stenting with DES Chieffo A et al. Ci

11、rculation 2007;116:158-162In HospitalFollow-Up (886308 days)Cardiac death, n (%)04 (2.7)Cardiac death in 60 high-risk patients, n (%)04 (6.6)Cardiac death in 87 low-risk patients, n (%)00Total death, n (%)1 (0.7)5 (3.4)Q-wave MI, n (%)01 (0.7)Non-Q-wave MI, n (%)5 (3.4)2 (1.4)TLR, n (%)1 (0.7)1 (0.7

12、)TVR, n (%)1 (0.7)7 (4.7)MACE, n (%)6 (4.0)11 (7.4)第21页/共44页CABG1.0Years after treatment0.02.03.005Cumulative Incidence (%)1510BMSCABG1.0Years after treatment0.02.03.005Cumulative Incidence (%)1510DESPhase IPhase IIHR 2.58 (1.35-4.94) HR 0.90 (0.56-1.45)MAIN COMPARE LM Registry Death or Q-wave MI (a

13、djusted)SJ Park et al; LM Summit 2007第22页/共44页1.0Years after treatment0.02.03.0010Cumulative Incidence ( %)30201.0Years after treatment0.02.03.0010Cumulative Incidence ( %)3020CABGBMSCABGDESHR 5.57 (3.13-9.88) P0.001HR 5.05 (2.87-8.67) P0.001MAIN COMPARE LM Registry Repeat Revascularization (adjuste

14、d)Phase IPhase IISJ Park et al; LM Summit 2007第23页/共44页CRF DES Evidence-based MedicineGuidelines Summary2008第24页/共44页CRF DES Evidence-based MedicineGuidelines Summary2008第25页/共44页Drug-eluting Stents in AMI (RCTs)第26页/共44页Drug-eluting Stents in AMI (RCTs)Mortality2.3%1.9%2.2%4.3%8%9%STRATEGY 8 mo(n=1

15、75)TYPHOON 12 mo(n=700)SESAMI 12 mo (n=320)DESBMS第27页/共44页Drug-eluting Stents in AMI (RCTs)Reinfarction1.1%1.8%1.4%1.8%7%9%STRATEGY 8 mo(n=175)TYPHOON 12 mo(n=700)SESAMI 12 mo (n=320)DESBMS第28页/共44页Drug-eluting Stents in AMI (RCTs)Stent thrombosis3.4%3.1%3.6%3.7%0%3%STRATEGY 8 mo(n=175)TYPHOON 12 mo

16、(n=700)SESAMI 12 mo (n=320)DESBMS第29页/共44页Drug-eluting Stents in AMI (RCTs)Target lesion revascularization3.7%4.3%12.6%11.2%6%20%STRATEGY 8 mo(n=175)TYPHOON 12 mo(n=700)SESAMI 12 mo (n=320)DESBMS第30页/共44页CRF DES Evidence-based MedicineGuidelines Summary2008第31页/共44页Cordis三代DES设计特点支架 平台设计 ）第32页/共44页D

17、ES设计的基本要素设计的基本要素药物&聚合物第33页/共44页Cordis三代DES设计特点输送系统 ） 第34页/共44页Cypher Select PlusCypher Select Plus的的CYPHCYPH2 2ONICONIC亲水涂层亲水涂层技术技术 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第35页/共44页 Cordis Corporation 2006. Confidential. For Internal Use Only - N

18、ot For Distribution.CYPHER Select+CYPHER Select+为什么选择改进推送系统？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 第36页/共44页摩擦阻力产生在SDS通过导管以

19、及血管弯曲的地方Friction ZoneFriction ZoneFriction Zone无亲水涂层的SDS外部有亲水涂层的Cypher Select Plus的外部Friction Points摩擦阻力摩擦阻力第37页/共44页光滑性测试光滑性测试第38页/共44页亲水涂层使得亲水涂层使得Cypher Select Plus 的外杆光滑程度比的外杆光滑程度比CYPHER高高94%00.010.020.030.040.050.060.070.08Bare ControlVisionTaxusDriverSelect +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光滑性测试第39

20、页/共44页 三维心脏模型推送试验结果025050075010001250150017502000CYPHERSELECT +(7)DRIVER (3)TAXUSLIBERTE(7)CYPHERNXT (6)ENDEAVOR(7)CYPHERSELECT (6)CYPHER(5)AVG WORK (g cm)平均推力越低越好Cypher Select Plus 推送力方面表现与任何合金DES支架同样好甚至更好三维心脏模型推送实验结果三维心脏模型推送实验结果第40页/共44页持久性测试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

21、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,证明涂层没有损耗第41页/共44页Plus Plus 的亲水涂层技术的亲水涂层技术总结总结 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第42页/共44页CYPHER 支架在不同病变和病人亚组中表现的循证医学Single, De NovoLongLesionsSmallVesselsDMMVDISRCTOBifur-cationsAMIDirectStentingStairway to Evidence-Based MedicineRAVEL, SIRIUS, REA