DES在復(fù)雜病變中的循證醫(yī)學(xué)使用指南

1、1會(huì)計(jì)學(xué)DES在復(fù)雜病變中的循證醫(yī)學(xué)使用指南在復(fù)雜病變中的循證醫(yī)學(xué)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 平臺(tái)設(shè)計(jì) ）藥物&聚合物輸送系統(tǒng) ） CYPH2ONIC 親水涂層-使得推送力能順滑的從支架近端推送桿傳遞到末梢頭端 Cordis Corporation 2006. Confidential. For Internal Use Only - Not For Distribution.輸送性的因素影響是那些？ 支架外形 支架材質(zhì) 頭端長度 支架的順應(yīng)性 還有么？我們發(fā)現(xiàn)：支架推送系統(tǒng)和血管壁之間的摩擦阻力、支架推送系統(tǒng)同導(dǎo)管壁之間的摩擦阻力影響著支架的推送性能這就意味著支架輸送系統(tǒng)的順滑程度對(duì)輸送性有很大的影響 CYPHER Select 增

14、強(qiáng)了輸送系統(tǒng)的特性:CYPH2ONIC 親水涂層 減小阻力，使支架的推送系統(tǒng)更加順滑短而柔韌的頭端通過性更好保持了SELECT 支架的柔韌性設(shè)計(jì) 摩擦阻力產(chǎn)生在SDS通過導(dǎo)管以及血管彎曲的地方Friction ZoneFriction ZoneFriction Zone無親水涂層的SDS外部有親水涂層的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對(duì)照相關(guān)產(chǎn)品的表面摩擦力試驗(yàn) 三維心臟模型推送試驗(yàn)結(jié)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 推送力方面表現(xiàn)與任何合金DES支架同樣好甚至更好該測試用來測量隨著推送摩擦次數(shù)的增加,涂層的損耗程度測試方法:分別測試第一次和第一百次通過固定好的“硅樹脂膜”(模擬導(dǎo)管和血管拐彎處的摩擦阻力)的力量,如果用力相同,證明涂層沒有損耗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