TAXUS Moderate Release Data Clinical Trial Results红豆杉中释放数据的临床试验的的结果-文档资料.ppt
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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
2、(loading dose 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 I SR = 267,TCT 2002,TAXUS n = 131,Control n = 136,Cohort II MR = 269,TAXUS n = 135,Control n = 134,Slow Release (SR),Moderate Re
3、lease (MR),30 Day Follow-up,6 Month Follow-up,Annually 1-5 Years,DMC,SR Follow-up Clinical: 99% Angiographic: 98% IVUS: 90%,MR Follow-up Clinical: 96% Angiographic: 95% IVUS: 87%,TAXUS II: Patient Demographics,TAXUS MR (%) Control (%) p-value (n=135) (n=134) Male 76.0 77.0 1.000 Mean Age (years) 59.
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