1、DES在復(fù)雜病變中的循證醫(yī)學(xué)使用指南16、自己選擇的路、跪著也要把它走完。17、一般情況下)不想三年以后的事，只想現(xiàn)在的事。現(xiàn)在有成就，以后才能更輝煌。18、敢于向黑暗宣戰(zhàn)的人，心里必須充滿光明。19、學(xué)習(xí)的關(guān)鍵-重復(fù)。20、懦弱的人只會裹足不前，莽撞的人只能引為燒身，只有真正勇敢的人才能所向披靡。DES在復(fù)雜病變中的循證醫(yī)學(xué)使用指南DES在復(fù)雜病變中的循證醫(yī)學(xué)使用指南16、自己選擇的路、跪著也要把它走完。17、一般情況下)不想三年以后的事，只想現(xiàn)在的事。現(xiàn)在有成就，以后才能更輝煌。18、敢于向黑暗宣戰(zhàn)的人，心里必須充滿光明。19、學(xué)習(xí)的關(guān)鍵-重復(fù)。20、懦弱的人只會裹足不前，莽撞的人只能引為

2、燒身，只有真正勇敢的人才能所向披靡。DES在復(fù)雜病變中的循證醫(yī)學(xué)使用指南EBM Guidelines for DESON LABEL - Safety (stent thrombosis, death and MI) and Efficacy (TLR)OFF LABEL Safety and EfficacyComplex Lesion SubsetsDES在復(fù)雜病變中的循證醫(yī)學(xué)使用指南16、自己選擇的路、跪著DES在復(fù)雜病變中的循證醫(yī)學(xué)使用指南46張課件DES在復(fù)雜病變中的循證醫(yī)學(xué)使用指南46張課件DES在復(fù)雜病變中的循證醫(yī)學(xué)使用指南46張課件DES在復(fù)雜病變中的循證醫(yī)學(xué)使用指南46張課件

3、OFF LABEL Use (DES)More complex and unapproved indications Very small vessels Ultra long lesions Chronic total occlusions Bifurcations Multivessel disease Left main disease In-stent restenosis Saphenous vein grafts Acute myocardial infarctionOFF LABEL Use (DES)More compleDES: Off-Label Use Safety ov

4、erall 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; Exc

5、eptions = unproven categories (sidebranch in bifurc, complex MVD, UPLM, SVGs, and AMI AND plavix compliance concerns DES: Off-Label Use Safety ovDedicated Trials with CYPHER Stent in Specific Patient/Lesion TypesSingle, De NovoLongLesionsSmallVesselsDMMVDISRCTOBifur-cationsAMIDirectStentingStairway

6、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 IITROPICALSISRRIBS IIINDEEDISAR-

7、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-SIRIUSSCANDSTENT, CORPAL, Ce

8、rvinka, et al. (high-risk)SVGRRISCDELAYED RRISCDedicated Trials with CYPHER CRF DES Evidence-based MedicineGuidelines Summary2008Very Small VesselsCRF DES Evidence-based MedicinSix-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

9、.8 13.0 14.8 14.5 12.9 17.0 12.1 Diabetes, % 27% 19% 19% 24% 0% 27% 40% Six-month Binary Restenosis iCRF DES Evidence-based MedicineGuidelines Summary2008IIa Very small vessels (smallest Cypher stent is 2.25mm; very little data available)CRF DES Evidence-based MedicinCRF DES Evidence-based MedicineG

10、uidelines Summary2008Chronic Total Occlusions CRF DES Evidence-based MedicinAdverse eventsat 6 months, %PRISON-II200 pts with CTO crossed by wire randomized to BX Velocity vs. CypherBx VelocityCypherSuttorp M et al. Circ 2006;114:921-8Adverse eventsPRISON-II200 ptFU angiographyat 6 months, %PRISON-I

11、I200 pts with CTO crossed by wire randomized to BX Velocity vs. CypherBx VelocityCypherSuttorp M et al. Circ 2006;114:921-8FU angiographyPRISON-II200 ptPRISON II: 36-month Clinical Follow-Up01020304050Clinical event (%)SES (n=100)BMS (n=100)455152535DeathMITLRp=NSp=NSp0.001TVRTVFMACEp=0.002p0.001p36

12、0 days2 (possible)3 (definite)Total2 (2%)5 (5%)B.M.Rahel, ACC 2008; Oral Presentation.PRISON II: Stent Thrombosis iCRF DES Evidence-based MedicineGuidelines Summary2008I- Chronic total occlusionsCRF DES Evidence-based MedicinCRF DES Evidence-based MedicineGuidelines Summary2008Bifurcation DiseaseCRF

13、 DES Evidence-based MedicinNordic Bifurcation RCT413 pts at 28 centers in 5 countries with true bifurcation 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 200

14、6N=206N=207MV stented (%)10098.5NSSB stented (%)4.395.10.001Kissing balloon (%)32743x nlP=0.01Nordic Bifurcation Study (n=41CRF DES Evidence-based MedicineGuidelines Summary2008IIa- Bifurcation (DES main branch, PTCA of side branch w/provisional DES)- Planned bifurcation dual DES (for diffusely dise

15、ased side branch 2.5 mm diameter with ostial involvement)IIb- Routine bifurcation dual DES (T, SKS (V), culotte or crush of sidebranch)CRF DES Evidence-based MedicinCRF DES Evidence-based MedicineGuidelines Summary2008Unprotected Left Main DiseaseCRF DES Evidence-based Medicin Ostial and Shaft LM St

16、enting with DES (COLOMBO, SERRUYS, PARK; n = 147 pts)Chieffo A et al. Circulation 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

17、, 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) Ostial and Shaft LM StentiCABG1.0Years after treatment0.02.03.005Cumulative Incidence (%)1510BMSCABG1.0Years after treatment0.02.03.005Cumulative Incidence (%)1510DESPhase IPha

18、se IIHR 2.58 (1.35-4.94) P=0.004HR 0.90 (0.56-1.45) P=0.664MAIN COMPARE LM Registry Death or Q-wave MI (adjusted)SJ Park et al; LM Summit 2007CABG1.0Years after treatment0.1.0Years after treatment0.02.03.0010Cumulative Incidence ( %)30201.0Years after treatment0.02.03.0010Cumulative Incidence ( %)30

19、20CABGBMSCABGDESHR 5.57 (3.13-9.88) P0.001HR 5.05 (2.87-8.67) P0.001MAIN COMPARE LM Registry Repeat Revascularization (adjusted)Phase IPhase IISJ Park et al; LM Summit 20071.0Years after treatment0.02.0CRF DES Evidence-based MedicineGuidelines Summary2008IIa- Unprotected Left Main (ostial or shaft;

20、non-complex)IIb Unprotected Left Main (bifurcation and complex; restricted to research or high risk for surgery)CRF DES Evidence-based MedicinCRF DES Evidence-based MedicineGuidelines Summary2008Acute Myocardial InfarctionCRF DES Evidence-based MedicinDrug-eluting Stents in AMI (RCTs)TrialDESBMSNAng

21、io FU1 EPSTRATEGY1CypherBx Vel175Yes8mo D, ReMI, CVA, or TVRTYPHOON2CypherAny 700Yes12mo TVFSESAMI3Cypher Bx Vel320Yes12mo restenosis1. 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 (RCDrug-eluting S

22、tents in AMI (RCTs)MortalityAll P=NSDrug-eluting Stents in AMI (RCDrug-eluting Stents in AMI (RCTs)ReinfarctionAll P=NSDrug-eluting Stents in AMI (RCDrug-eluting Stents in AMI (RCTs)Stent thrombosisAll P=NSDrug-eluting Stents in AMI (RCDrug-eluting Stents in AMI (RCTs)Target lesion revascularization

23、P=0.023P=0.006P0.001P0.001Drug-eluting Stents in AMI (RCIIbCRF DES Evidence-based MedicineGuidelines Summary2008 Acute myocardial infarction (due to safety concerns)IIbCRF DES Evidence-based MediCordis三代DES設(shè)計(jì)特點(diǎn)支架 平臺設(shè)計(jì)）Cordis三代DES設(shè)計(jì)特點(diǎn)支架 平臺設(shè)計(jì)DES設(shè)計(jì)的基本要素藥物&聚合物DES設(shè)計(jì)的基本要素藥物&聚合物Cordis三代DES設(shè)計(jì)特點(diǎn)輸送系統(tǒng)）Cordis三代

24、DES設(shè)計(jì)特點(diǎn)輸送系統(tǒng)Cypher Select Plus的CYPH2ONIC親水涂層技術(shù)涂層在SDS 的遠(yuǎn)端體部之外具體位置在從與導(dǎo)絲交換點(diǎn)到近球囊封點(diǎn)之間的大約9英寸距離(25厘米長)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Cypher Select Plus的CYPH2ONIC親水 Cordis Corporation 2006. Confidential. For Internal Use Only - Not For Distribution.CYPHER Select+為什么選擇改進(jìn)推送系統(tǒng)？輸送性的因素影響是那些？ 支架外形 支架材質(zhì) 頭端長

25、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)的順滑程度對輸送性有很大的影響 CYPHER Select 增強(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) Cordis Corporation 2006. Con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 P

26、lus的外部Friction Points摩擦阻力摩擦阻力產(chǎn)生在SDS通過導(dǎo)管以及血管彎曲的地方Frictio光滑性測試光滑性測試親水涂層使得Cypher Select Plus 的外桿光滑程度比CYPHER高94%表面摩擦力越低越好對照相關(guān)產(chǎn)品的表面摩擦力試驗(yàn)光滑性測試越低越好對照相關(guān)產(chǎn)品的表面摩擦力試驗(yàn)光滑性測試 三維心臟模型推送試驗(yàn)結(jié)果025050075010001250150017502000CYPHERSELECT +(7)DRIVER (3)TAXUSLIBERTE(7)CYPHERNXT (6)ENDEAVOR(7)CYPHERSELECT (6)CYPHER(5)AVG WOR

27、K (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三維心臟模型推送實(shí)驗(yàn)結(jié)果 三維心臟模型推送試驗(yàn)結(jié)果02505007501000125持久性測試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,證明涂層沒有損耗持久性測試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Plus 的親水涂層技術(shù)總結(jié)特別為(CYPH2ONIC) CYPHER Select +研制的光滑外涂層使SDS在摩擦區(qū)域的摩擦阻力減少了90%以上,使得推送力更加順滑的從近端傳向遠(yuǎn)端,而且涂層保持良好的持久性減少摩擦即意味著省力和易推送相對于Cypher Select來說,在推送性方面釋放了可以更多可以提高的潛能Plus 的親水涂層技術(shù)總結(jié)CYPHER 支架在不同病變和病人亞組中表現(xiàn)的循證醫(yī)學(xué)Single, De NovoLongLesionsSmallVesselsDMMVDISRCTO