在复杂病变中的循证医学使用指南

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: duration 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 indications Very small vessels Ultra long lesions Chronic total occlusions Bifurcations Multivessel disease Left main disease In-stent restenosis Saphenous vein grafts Acute myocardial infarction DES: Off-Label Use 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 subsets Use Recommendations predominant DES; Exceptions = unproven categories (sidebranch in bifurc, complex MVD, UPLM, SVGs, and 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., 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 not been presented/published Randomized Controlled Trial (RCT) vs. BMS, Brachytherapy, or POBA NON-RCT RCTs VS. DES SIRTAX, BAS KET , 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 Evidence-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 Guidelines Summary 2008 IIa - 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 eventsat 6 months, % PRISON-II 200 pts with CTO crossed by wire randomized to BX Velocity vs. Cypher Bx Velocity Cypher Suttorp M et al. Circ 2006;114:921-8 FU angiographyat 6 months, % PRISON-II 200 pts with CTO crossed by wire randomized to BX Velocity vs. Cypher Bx Velocity Cypher Suttorp M et al. Circ 2006;114:921-8 PRISON II: 36-month Clinical Follow-Up 0 10 20 30 40 50 Clinical event (%) SES (n=100)BMS (n=100) 45 5 15 25 35 Death MI TLR p=NS p=NS p360 days 2 (possible) 3 (definite) Total 2 (2%) 5 (5%) B.M.Rahel, ACC 2008; Oral Presentation. CRF DES Evidence-based Medicine Guidelines Summary 2008 I - 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 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 N=206 N=207 MV stented (%) 100 98.5 NS SB stented (%) 4.3 95.1 3x nl P=0.01 CRF DES Evidence-based Medicine Guidelines Summary 2008 IIa - Bifurcation (DES main branch, PTCA of side branch w/provisional DES) - Planned bifurcation dual DES (for diffusely diseased 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 Medicine Guidelines Summary 2008 Unprotected Left Main Disease Ostial and Shaft LM Stenting with DES (COLOMBO, SERRUYS, PARK; n = 147 pts) Chieffo A et al. Circulation 2007;116:158-162 In Hospital Follow-Up (886308 days) Cardiac death, n (%) 0 4 (2.7) Cardiac death in 60 high- risk patients, n (%) 0 4 (6.6) Cardiac death in 87 low-risk patients, n (%) 0 0 Total death, n (%) 1 (0.7) 5 (3.4) Q-wave MI, n (%) 0 1 (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) 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 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 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) IIb - Unprotected Left Main (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 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 Drug-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 IIb 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 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 试验结果 0 250 500 750 1000 1250 1500 1750 2000 CYPHERSELECT + (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 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 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 Vesse