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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 m,TCT 2002,Inclusion Criteria Standard risk de novo lesions Length 3.0 mm&75 mg(loading dose and m
2、aintained 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 Follow-u
3、p,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 SR(%)Control(%)p-value(n=131)(n=136)Male70.278.70.124 Mean Age(years)61.5+10.560.4+9.30.379 Prior MI35.141.9 0.317 Prior Intervention11.516.90
4、.223 Diabetes10.716.20.159 Unstable Angina35.131.90.605 Hypertension62.666.90.522 Smoker21.425.00.562,TCT 2002,TAXUS II:Baseline Lesion Characteristics,TCT 2002,TAXUS SR Controlp-value(n=131)(n=136)RVD(mm)2.78+0.44 2.77+0.49 0.921 MLD(mm)1.02+0.30 1.03+0.34 0.650 Diameter Stenosis(%)63.3+9.6 62.8+9.
5、9 0.681 Lesion Length(mm)10.55+3.9 10.51+4.1 0.931,TAXUS II:Primary Endpoint,In-stent Net Volume Obstruction at 6 Month IVUS,TAXUS SRStent,ControlStent,62%reductionp 0.0001,TCT 2002,n=118,n=125,%In-stent Net Volume Obstruction,TAXUS II:Clinical Events Through 6 Months,Target Lesion Revascularization
6、,MACE*,*Defined as cardiac death,MI,TVR,p=0.043,p=0.013,TCT 2002,TAXUS SRStent,ControlStent,TAXUS SRStent,ControlStent,Restenosis(%),Proximal Edge(5 mm)p=1.000,TAXUS II:6 Month Angiographic Restenosis,Stented Segmentp=0.0002,Distal Edge(5 mm)p=0.685,TCT 2002,TAXUS SRStent,ControlStent,n=127,n=134,TA
7、XUS SRStent,ControlStent,TAXUS SRStent,ControlStent,(mm),Proximal Edgep=0.009,TAXUS II:6 Month Angiographic MLD,Stented Segmentp0.0001,Distal Edgep=0.039,TCT 2002,TAXUS SRStent,ControlStent,n=127,n=134,TAXUS SRStent,ControlStent,TAXUS SRStent,ControlStent,TAXUS II:Late Loss and Loss Index in Stented Segment,Late Loss,Loss Index,p0.0001,TCT 2002,TAXUS SRStent,ControlStent,TAXUS SRStent,ControlStent,(mm),p0.0001,n=127,n=134,n=125,n=134,
