DES在复杂病变中的循证医学使用指南

1、1会计学DES在复杂病变中的循证医学使用指南在复杂病变中的循证医学使用指南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 s

2、ubsetsUse Recommendations predominant DES; Exceptions = unproven categories (sidebranch in bifurc, complex MVD, UPLM, SVGs, and AMI AND plavix compliance concernsSingle, De NovoLongLesionsSmallVesselsDMMVDISRCTOBifur-cationsAMIDirectStentingStairway to Evidence-Based MedicineRAVEL, SIRIUS, REALITY,

3、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 IITROPICALSISRRIBS IIINDEEDISAR-DESIREARTS-2SIRIUS-BIFNordic PCIDiffering Complexi

4、ty* 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-SIRIUSSCANDSTENT, CORPAL, Cervinka, et al. (high-risk)SVGRRISCDELAYED RRISCCRF

5、 DES Evidence-based MedicineGuidelines Summary20086.39.85.82.311.49.616.90369121518SVELTESES-SMARTE-SIRIUSC-SIRIUSISAR-SMARTREALITYSIRIUS 2.25Binary restenosis at 6 months, %Six-month Binary Restenosis in Small-Vessel SES Trials Mean RVD, mm 2.37 2.20 2.59 2.65 2.44 2.40 2.04Mean l/ length, mm 14.8

6、13.0 14.8 14.5 12.9 17.0 12.1 Diabetes, % 27% 19% 19% 24% 0% 27% 40% CRF DES Evidence-based MedicineGuidelines Summary2008CRF DES Evidence-based MedicineGuidelines Summary200801020304050Clinical event (%)SES (n=100)BMS (n=100)455152535DeathMITLRp=NSp=NSp0.001TVRTVFMACEp=0.002p0.001p360 days2 (possib

7、le)3 (definite)Total2 (2%)5 (5%)B.M.Rahel, ACC 2008; Oral Presentation.CRF DES Evidence-based MedicineGuidelines Summary2008CRF DES Evidence-based MedicineGuidelines Summary2008N=206N=207MV stented (%)10098.5NSSB stented (%)4.395.10.001Kissing balloon (%)32740.001Tx successful (%)*9795NS1.01.41.01.4

8、1.44.01.51.02.02.54.8002468DeathMIStentTLRTVRMACE8.018.005101520CKMBP=0.01CRF DES Evidence-based MedicineGuidelines Summary2008CRF DES Evidence-based MedicineGuidelines Summary2008Chieffo A et al. Circulation 2007;116:158-162In HospitalFollow-Up (886308 days)Cardiac death, n (%)04 (2.7)Cardiac death

9、 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)TVR, n (%)1 (0.7)7 (4.7)MACE, n (%)6 (4.0)11 (7.4)CABG1.0Years after treatment0.02.03.005Cumulative

10、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)SJ Park et al; LM Summit 20071.0Years after treatment0.02.03.0010Cumulative Incidence ( %)30201.0Years after treatment0.02.03.0010Cumulative Incidence ( %)3

11、020CABGBMSCABGDESHR 5.57 (3.13-9.88) P0.001HR 5.05 (2.87-8.67) P0.001Phase IPhase IISJ Park et al; LM Summit 2007CRF DES Evidence-based MedicineGuidelines Summary2008CRF DES Evidence-based MedicineGuidelines Summary20082.3%1.9%2.2%4.3%8%9%STRATEGY 8 mo(n=175)TYPHOON 12 mo(n=700)SESAMI 12 mo (n=320)D

12、ESBMS1.1%1.8%1.4%1.8%7%9%STRATEGY 8 mo(n=175)TYPHOON 12 mo(n=700)SESAMI 12 mo (n=320)DESBMS3.4%3.1%3.6%3.7%0%3%STRATEGY 8 mo(n=175)TYPHOON 12 mo(n=700)SESAMI 12 mo (n=320)DESBMS3.7%4.3%12.6%11.2%6%20%STRATEGY 8 mo(n=175)TYPHOON 12 mo(n=700)SESAMI 12 mo (n=320)DESBMSCRF DES Evidence-based MedicineGui

13、delines Summary2008支架 平台设计 ）药物&聚合物输送系统 ） 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.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

14、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 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 Points00.010.020.030.040.050.060.070.08Bare ControlVisionTaxusDriverSelect +表面摩擦力越低越好对照相关产品的表面摩擦力试验 三维心脏模型推送试验结果025050

15、075010001250150017502000CYPHERSELECT +(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Single, De NovoLongLesionsSm

16、allVesselsDMMVDISRCTOBifur-cationsAMIDirectStentingStairway to Evidence-Based MedicineRAVEL, SIRIUS, REALITY, ENDEAVOR III, Pache, et al., Petronio, et al., Han., et al.DIRECTTYPHOONSTRATEGYSESAMIMISSIONDiazPROSITPark LLPark LL 2SVELTE,SIRIUS 2.25SES-SMARTISAR-SMART 3PORTO IDECODESCORPIUSDIABETESDES

17、SERTCARDIA*ISAR-DIABETESKorean RCTDECLARE- DIABETESSwedish RCTItalian w/in Pt RCTACROSSPRISON IITROPICALSISRRIBS IIINDEEDISAR-DESIREARTS-2SIRIUS-BIFNordic PCIDanish RCT* Trials have not been presented/publishedRandomized Controlled Trial (RCT) vs. BMS, Brachytherapy, or POBANON-RCTRCTs VS. DESAND MO

18、RE TO COMESIRTAX, BASKET, and TAXi (All-Comers), Zhang, et al. SORT-OUT II, Ortlani, et al.,E-SIRIUS, C-SIRIUSSCANDSTENT, CORPAL, Cervinka, et al. (high-risk), PetronioSVGRRISCDELAYED RRISCSafety 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 subsetsUse Recommendations predominant DES; Exceptions = unproven categories (sidebranch in bifurc, comp