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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,LongLesions,SmallVessels,DM,MVD,ISR,CTO,Bifur-cations,AMI,DirectStenting,Stairway to Evidence-Based Medicine,RAVEL, SIRIUS, REALITY, ENDEAVOR III, Pache, et al., Petronio, e
6、t al., Han., et al.,DIRECT,TYPHOONSTRATEGYSESAMIMISSIONPROSIT,Park LLPark LL 2,SVELTE,SIRIUS 2.25SES-SMARTISAR-SMART 3,PORTO IDECODESCORPIUSDIABETES, CARDIA*ISAR-DIABETES,ACROSS PRISON II,TROPICAL SISRRIBS IIINDEEDISAR-DESIRE,ARTS-2,SIRIUS-BIFNordic PCI,Differing Complexity,* Trials have not been pr
7、esented/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,RRISCDELAYED RRISC,CRF DES Evidence-based
8、 MedicineGuidelines Summary2019,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 MedicineGuidelines Summary2019
9、,Very small vessels (smallest Cypher stent is 2.25mm; very little data available),CRF DES Evidence-based MedicineGuidelines Summary2019,Chronic Total Occlusions,Adverse events at 6 months, %,PRISON-II200 pts with CTO crossed by wire randomized to BX Velocity vs. Cypher,Suttorp M et al. Circ 2019;114
10、:921-8,FU angiography at 6 months, %,PRISON-II200 pts with CTO crossed by wire randomized to BX Velocity vs. Cypher,Suttorp M et al. Circ 2019;114:921-8,PRISON II: 36-month Clinical Follow-Up,B.M.Rahel, ACC 2019; Oral Presentation.,PRISON II: Stent Thrombosis in Target Vessel at 36 Month Follow-Up,B
11、.M.Rahel, ACC 2019; Oral Presentation.,CRF DES Evidence-based MedicineGuidelines Summary2019,- Chronic total occlusions,CRF DES Evidence-based MedicineGuidelines Summary2019,Bifurcation Disease,Nordic Bifurcation RCT413 pts at 28 centers in 5 countries with true bifurcation received Cypher in main v
12、essels 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 2019,Nordic Bifurcation Study (n=413)Major Endpoints (clinically driven),Steigen TC et al. ACC 2019,Primary endpoint P=0.30,In-hospital
13、 MI (%),6 month MACE (%),thrombosis,3x nl,P=0.01,CRF DES Evidence-based MedicineGuidelines Summary2019,- Routine bifurcation dual DES (T, SKS (V), culotte or crush of sidebranch),CRF DES Evidence-based MedicineGuidelines Summary2019,Unprotected Left Main Disease,Ostial and Shaft LM Stenting with DES
14、,(COLOMBO, SERRUYS, PARK; n = 147 pts),Chieffo A et al. Circulation 2019;116:158-162,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 0.9
15、0 (0.56-1.45) P=0.664,MAIN COMPARE LM Registry Death or Q-wave MI (adjusted),SJ Park et al; LM Summit 2019,1.0,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) P0.00
16、1,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 2019,CRF DES Evidence-based MedicineGuidelines Summary2019,IIa,- Unprotected Left Main (ostial or shaft; non-complex),Unprotected Left Main (bifurcation and complex; restricted to research or high risk for surgery),CRF DES E
