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1、,TAXUS II:Study Overview,Randomized 1:1 Triple-blind 536 Patients TAXUSTM NIRxTM SR(n=267)TAXUSTM NIRxTM MR(n=269)30 day,6 month,1-5 year F/U Primary endpoint:%in-stent net volume obstruction(IVUS)at 6 months,TCT 2002,Inclusion Criteria Standard risk de novo lesions Length 3.0 mm&75 mg(loading dose
2、and maintained indefinitely)Clopidogrel(loading dose 300mg and 75 mg q.d.for 6 months),TAXUS II:Two Consecutive Cohorts,Slow and Moderate Release,Cohort ISR=267,TCT 2002,TAXUSn=131,Controln=136,Cohort IIMR=269,TAXUSn=135,Controln=134,Slow Release(SR),Moderate Release(MR),30 Day Follow-up,6 Month Fol
3、low-up,Annually1-5 Years,DMC,SR Follow-upClinical:99%Angiographic:98%IVUS:90%,MR Follow-upClinical:96%Angiographic:95%IVUS:87%,TAXUS II:Patient Demographics,TAXUS MR(%)Control(%)p-value(n=135)(n=134)Male76.077.01.000 Mean Age(years)59.3+10.159.3+10.00.977 Prior MI39.042.0 0.620 Prior Intervention17.
4、013.00.392 Diabetes17.014.00.615 Unstable Angina30.040.00.123 Hypertension60.056.00.538 Smoker24.029.00.411,TCT 2002,TAXUS II:Baseline Lesion Characteristics,TCT 2002,TAXUS MR Controlp-value(n=135)(n=134)RVD(mm)2.72+0.5 2.73+0.5 0.769 MLD(mm)0.95+0.3 0.91+0.4 0.380 Diameter Stenosis(%)64.9+10.3 66.6
5、+11.8 0.205 Lesion Length(mm)10.16+4.8 10.71+4.1 0.309,TAXUS II:Primary Endpoint,In-stent Net Volume Obstruction at 6 Month IVUS,TAXUS MRStent,ControlStent,62%reductionp 0.0001,n=118,n=119,%In-stent Net Volume Obstruction,TCT 2002,TAXUS II:Clinical Events Through 6 Months,Target Lesion Revasculariza
6、tion,MACE*,*Defined as cardiac death,MI,TVR,p=0.002,p=0.006,TCT 2002,TAXUS MRStent,ControlStent,TAXUS MRStent,ControlStent,Restenosis(%),Proximal Edge(5 mm)p=0.3339,TAXUS II:6 Month Angiographic Restenosis,Stented Segmentp0.0001,Distal Edge(5 mm)p=1.000,TCT 2002,TAXUS MRStent,ControlStent,n=128,n=12
7、9,TAXUS MRStent,ControlStent,TAXUS MRStent,ControlStent,(mm),Proximal Edgep=0.005,TAXUS II:6 Month Angiographic MLD,Stented Segmentp0.0001,Distal Edgep=0.013,TCT 2002,TAXUS MRStent,ControlStent,n=135,n=134,TAXUS MRStent,ControlStent,TAXUS MRStent,ControlStent,TAXUS II:Late Loss and Loss Index in Stented Segment,Late Loss,Loss Index,p0.0001,TCT 2002,TAXUS MRStent,ControlStent,TAXUS MRStent,ControlStent,(mm),p0.0001,n=127,n=130,n=127,n=130,
