DES在复杂病变中的循证医学使用指南.ppt
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1、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: durati
2、on 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
3、 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 sugge
4、sts 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, SV
5、Gs, 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., Petroni
6、o, 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,* Tri
7、als have not been presented/published,Randomized Controlled Trial (RCT) vs. BMS, Brachytherapy, or POBA NON-RCT RCTs VS. DES,SIRTAX, BASKET, 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,C
8、RF 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 Medicin
9、e Guidelines Summary 2008,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 events at 6 months, %,PRISON-II 200 pts with CTO crossed by wire randomized to BX Velocity vs. Cypher,Su
10、ttorp M et al. Circ 2006;114:921-8,FU angiography at 6 months, %,PRISON-II 200 pts with CTO crossed by wire randomized to BX Velocity vs. Cypher,Suttorp M et al. Circ 2006;114:921-8,PRISON II: 36-month Clinical Follow-Up,B.M.Rahel, ACC 2008; Oral Presentation.,PRISON II: Stent Thrombosis in Target V
11、essel at 36 Month Follow-Up,B.M.Rahel, ACC 2008; Oral Presentation.,CRF DES Evidence-based Medicine Guidelines Summary 2008,- 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 bif
12、urcation 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,Nordic Bifurcation Study (n=413) Major Endpoints (clinically driven),Steigen TC et al. ACC 2006,
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