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1、TAXUS IV 2-Year Clinical Results The safety and effectiveness of the TAXUSTM Express2TM Paclitaxel-Eluting Coronary Stent System have been established up to 12 months in the treatment of de novo lesions 28mm in length in native coronary arteries 2.5 to 3.75mm in diameter. Please refer to the directi
2、ons for use for the clinical experience observed in three clinical studies TAXUS IV, II and I. TAXUS and Express are trademarks of Boston Scientific Corporation or its affiliates. Copyright 2004 by Boston Scientific Corporation or its affiliates. All rights reserved. ControlControl (n=652)(n=652) St
3、udy populationStudy population (n=1,314)(n=1,314) 12-month follow-up12-month follow-up (n=1,272; 97%)(n=1,272; 97%) ControlControl (n=633)(n=633) 2-year follow-up2-year follow-up (n=1,238; 94%)(n=1,238; 94%) ControlControl (n=613)(n=613) TAXUS IV Clinical Trial:TAXUS IV Clinical Trial: Patient FlowP
4、atient Flow TAXUS TAXUS StentStent (n=662)(n=662) TAXUS IV Clinical Trial- TAXUS Express Stent / Control- Express Stent TAXUS TAXUS StentStent (n=639)(n=639) TAXUS TAXUS StentStent (n=625)(n=625) TAXUS IV Clinical Trial:TAXUS IV Clinical Trial: Baseline Clinical FeaturesBaseline Clinical Features Co
5、ntrol (n=652) TAXUS Stent (n=662) P-Value Age (yrs)62.1 10.962.8 11.20.21 Male gender72.4%71.8%0.81 Diabetes mellitus*25.0%23.4%0.52 - insulin requiring8.3%7.7%0.76 Hypertension69.0%70.5%0.55 Hyperlipidemia65.6%65.0%0.82 Current smoker20.1%23.4%0.16 Prior MI29.9%30.5%0.86 Unstable angina32.7%35.8%0.
6、25 TAXUS IV Clinical Trial- TAXUS Express Stent / Control- Express Stent The safety and effectiveness of the TAXUS Express Stent have not been established in patients with diabetes. TAXUS IV Clinical Trial:TAXUS IV Clinical Trial: 2-Year Revascularization2-Year Revascularization P 3.0 3.0 2.5-3.02.5
7、-3.0 60 degrees) in the region of the obstruction or proximal to the lesion. Patients with a recent acute myocardial infarction where there is evidence of thrombus or poor flow. Patients with multiple overlapping stents. Patients with longer than 12 month follow-up. Prior to use, please see the comp
8、lete “Directions for Use” at www.taxus- for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operators Instructions. CAUTION Federal law restricts this product to sale by or on the order of a physician. TRADEMARKS TAXUS, Express2 and Express are trademarks of Boston Scientific Corporation or its affiliates NIR is a trademark of Medinol, Ltd., Jerusalem, Israel.
