远端保护装置在ami患者急诊pci中的应用价值课件

,药物支架的评价与新进展,首都医科大学附属北京安贞医院 刘宇扬 周玉杰,The latest update and evaluation of Drug Eluting Stent,Stent Wars,1977-87,Lasers, rotational, “polishers”,the mid-80s,Toulouse, Jacques Puel & Ulrich Sigwart first stent into a human coronary artery.,1986,Palmaz-Schatz stent was approved for use in the United States.,1994,Close up again (30%),CYPHER APRIL 2003,TAXUS MARCH 2004,ENDEAVOR APRIL 2005/2008,XIENCE 2006,Bioresotable CoStart, Custom NX, Nobbori,EPCs-Genous,STENT WARS- evolution of DES,2003,2004,2005,Cypher approval,Taxus approval,U.S. penetration of DES (% of PCIs using at least one DES),DTCA FOR DES,Thrombosis,从ESC“Fire Storm” 到TCT“Crossfire”,Cypher&Taxus meta-analysis-ST,Taxus-, , , , , SIRIUS,E-SIRIUS, C-SIRUS,Ajay J. Kirtane, M.D., S.M. Gregg W. Stone, M.D.,Comprehensive Meta-Analysis of DES vs. BMS Randomized Trials and Registries,Presented at ACC 2008,All-Cause Mortality: All RCTs,8,867 patients, 21 trials,Favors BMS,Estimate (95% CI),Weight (%),0.97 (0.81,1.15) 0.97 (0.81,1.15), p=0.72,Random Effects *Fixed Effects (I2=0.0%),Favors DES,Mean f/u 2.9 yrs,Ajay J. Kirtane and Gregg W. Stone, 2008,All-Cause Mortality: RCTs (On-Label),4,818 patients, 10 trials,Favors DES,Favors BMS,Estimate (95% CI),Weight (%),1.05 (0.84,1.30) 1.05 (0.84,1.30), p=0.69,Random Effects *Fixed Effects (I2=0.0%),Mean f/u 4.0 yrs,Ajay J. Kirtane and Gregg W. Stone, 2008,All-Cause Mortality: RCTs (Off-Label),4,049 patients, 12 trials,Favors DES,Favors BMS,Estimate (95% CI),Weight (%),0.84 (0.62,1.13) 0.84 (0.62,1.13), p=0.24,Random Effects *Fixed Effects (I2=0.0%),Mean f/u 1.5 yrs,Ajay J. Kirtane and Gregg W. Stone, 2008,All-Cause Mortality: All Registries,161,232 patients, 28 registries,Favors BMS,Estimate (95% CI),Weight (%),0.80 (0.72,0.88), p0.001 0.83 (0.79,0.86),Favors DES,*Random Effects (I2=70.1%) Fixed Effects,Mean f/u 2.5 yrs,Ajay J. Kirtane and Gregg W. Stone, 2008,All-Cause Mortality: Adjusted Registries,134,534 patients, 18 registries,Favors BMS,Estimate (95% CI),Weight (%),0.80 (0.72,0.90), p0.001 0.82 (0.79,0.86),Favors DES,*Random Effects (I2=76.6%) Fixed Effects,Mean f/u 2.7 yrs,Ajay J. Kirtane and Gregg W. Stone, 2008,MI: RCTs (Off Label),4,532 patients, 12 trials,Estimate (95% CI),Weight (%),Favors DES,Favors BMS,0.77 (0.54,1.10) 0.83 (0.62,1.10), p=0.19,Random Effects *Fixed Effects (I2=25.5%),Ajay J. Kirtane and Gregg W. Stone, 2008,Mean f/u 1.5 yrs,TVR: All RCTs,7,291 patients, 16 trials,Favors DES,Favors BMS,Estimate (95% CI),Weight (%),0.45 (0.37,0.54), p0.001 0.51 (0.45,0.57),*Random Effects (I2=53.2%) Fixed Effects,Mean f/u 3.2 yrs,TVR: All Registries,73,819 patients, 17 registries,Favors DES,Favors BMS,Estimate (95% CI),Weight (%),0.53 (0.47,0.61), p0.001 0.57 (0.54,0.60),*Random Effects (I2=71.2%) Fixed Effects,Mean f/u 2.2 yrs,Ajay J. Kirtane and Gregg W. Stone, 2008,All-Cause Mortality: Adjusted Registries,134,534 patients, 18 registries,Favors BMS,Estimate (95% CI),Weight (%),0.80 (0.72,0.90), p0.001 0.82 (0.79,0.86),Favors DES,*Random Effects (I2=76.6%) Fixed Effects,Mean f/u 2.7 yrs,Ajay J. Kirtane and Gregg W. Stone, 2008,Conclusions(1),In 22 RCTs in which 9,470 pts were randomized to DES or BMS and followed for 1 yr, DES resulted in: Non significant 3% and 6% reductions in mortality and MI respectively A highly significant 55% reduction in TVR In 30 registries in which 174,302 pts were treated with either DES or BMS (non-randomized) and followed for 1 yr, DES was associated with: A highly significant 20% reduction in mortality A significant 11% reduction in MI A highly significant 47% reduction in TVR,Conclusions (2),The favorable results of DES from the RCT and registry analysis populations were robust and consistent for both on-label and off-label use, and for clinical f/u extending to 3-4 years These findings, derived from more than 180,000 pts treated in 52 studies, strongly suggest that DES are safe for both on-label and off-label use, and have comparable efficacy in both RCTs and in the “real-world”,SCARR Study,SCARR- REGISTRY Stent thrombosis,Time (years),2,1,0,Cumulative risk of stent thrombosis %,2,1,0,DES n=21 717,BMS n=20 058,Stent typ,Total cohort N=41 775 stents,0.5% per year,Unadjusted,Drug eluting stent- 3 elements,better DES- backbone,Major change Thin stent struts Stent geometry homogenous drug distribution stent fracture Special designed stent for complex lesions,Profile Flexibility Deliverability Less injury,Evolution of stent material,316L stainless steel,Nickel-titan alloy,Nickel-titan alloy With platinum,Cobalt chromium alloy,Magnesium-alloy absorbale,More flexible, thin, radial strength,NEW STENT PLATFORM=PERSS,Better DES- drug related issues,VOICE OF TCT 2008,ISAR-TEST 2,ISAR-TEST 2,Drug carrier system,Yoritaka Otsuka, etal. The Journal of Invasive Cardiology 04/19/2007,BiodivYsio: poly phosphorylcholine-lauryl methacrylate Taxus: poly styrene-isobutyl-styrene Cypher: poly-n-butyl methacrylate + polyethylene-vinyl acetate,Potential risk produced by polymers,thrombosis at cracking sites coronary microembolism of polymer pieces excessive chronic inflammatory neointimal reactions,Potential Risks,XIENCE Durable Fluoropolymer,Process of endothelialization,Biodegradable Polymers,DES With Biodegradable Polymer,Biomatrix - Biosensor International Excel - JW Medical; Biosensor International Nobori - Terumo; Biosensor International Axxess - Devax; Biosensor International Custom - Xtent; Biosensor International,CoStar Bioresorbable Polymer,NOBORI VS CYPHER at 9 months,NOBORI VS TAXUS at 2yrs,Summary,DES with biodegradable polymer is safe and effective with: Very low rate of MACE Low rate of restenosis No or very low rate of LST with 6 months dual anti-platelet regiment Better recovery of endothelial function,EPCs-capturing stent,48 hr explant Balloon injury porcine arteries,High risk of restenosis,Genous Stent,Taxus stent,Statins 1 wk,TRIAS HR Pilot study,Lesion 23 mm RVD 2.8mm Diabetes CTO,Design,Taxus N=92,Genous N=95,P-value,TRIAS HR Pilot study,Results,6-month clinical outcome,* (death, MI, TLR),GENOUS stent-1 year result of 2 studies,321 pts with ASTEMI undergoing primary PCI 3 cases of stent thrombosis (0.9%), 42 cases of MACE (13.1%), 24 deaths (7.5%), 12 recurrent MI (3.7%), and 16 TVR (5%) at 1year,257 pts with complex lesions 3% of pts died, 2.5% MI, and 9.7% TVR; definite stent thrombosis in 1.2% of cases. The cumulative rate of major adverse coronary events was 11.4% at one year,Genous stent could reduce restenosis without the need for prolonged dual-antiplatelet therapy,Present at TCT 2008,The trend ,Why a bioabsorbable stent?,Case 1 : Diffused LAD lesion,Stent fracture,Stent fracture-appearance in IVUS,MISSING STRUT,Bioabsorbable stents,Abbotts Bioabsorbable Everolimus Eluting Stent,Poly-L-lactic acid backbone,Bioabsorbable polymer,Coated with everolimus,Results form ABSORB Trial,63 patients enrolled, no patients experienced stent thrombosis,ABSORB Trial. ACC 2007,2-yrs Results from ABSORB Trial present at TCT 2008,bioabsorbable everolimus-eluting stent had a low risk of MACE during 2 yrs,The universe of futuristic DES,Stent platform: More flexible, thin, radial strength Drug: less toxic, lower doses, combination therapy (antiproliferative + pro-healing + thrombo-resistant) Polymer: biocompatible, or bioabsorbable materials, and stent surface modification technique Bioabsorbable stent: safer long-term solution(?),Thank you for your attention!,Promising carriers in future,Ongoing Clinical Trials,Future safe DES platformEndothelium is the key!,Adverse outcome of stent fracture,Stent fracture appears to