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TAXUS II: Slow Release Formula An International, Randomized, Multicenter, Blinded Trial of TAXUS TM NIRx TM SR Stent

TAXUS II: Slow Release Formula An International, Randomized, Multicenter, Blinded Trial of TAXUS TM NIRx TM SR Stent. Presented at TCT 2002. TAXUS II: Study Overview. Randomized 1:1 Triple-blind 536 Patients TAXUS TM NIRx TM SR (n=267) TAXUS TM NIRx TM MR (n=269)

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TAXUS II: Slow Release Formula An International, Randomized, Multicenter, Blinded Trial of TAXUS TM NIRx TM SR Stent

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  1. TAXUS II: Slow Release FormulaAn International, Randomized, Multicenter, Blinded Trial of TAXUSTM NIRxTM SR Stent Presented at TCT 2002

  2. 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 • Inclusion Criteria • Standard risk de novo lesions • Length <12 mm • RVD >3.0 mm & <3.5 mm • Antiplatelet Regimen • ASA >75 mg (loading dose and maintained indefinitely) • Clopidogrel (loading dose 300mg and 75 mg q.d. for 6 months) TCT 2002

  3. TAXUS II: Two Consecutive Cohorts, Slow and Moderate Release Moderate Release (MR) Slow Release (SR) Cohort I SR = 267 Cohort II MR = 269 DMC TAXUS n = 131 Control n = 136 TAXUS n = 135 Control n = 134 30 Day Follow-up MR Follow-up Clinical: >96% Angiographic: >95% IVUS: >87% SR Follow-up Clinical: >99% Angiographic: >98% IVUS: >90% 6 Month Follow-up Annually 1-5 Years TCT 2002

  4. TAXUS II: Patient Demographics TAXUS SR (%)Control (%) p-value (n=131) (n=136) Male 70.2 78.7 0.124 Mean Age (years) 61.5+10.5 60.4+9.3 0.379 Prior MI 35.1 41.9 0.317 Prior Intervention 11.5 16.9 0.223 Diabetes 10.7 16.2 0.159 Unstable Angina 35.1 31.9 0.605 Hypertension 62.6 66.9 0.522 Smoker 21.4 25.0 0.562 TCT 2002

  5. TAXUS II: Baseline Lesion Characteristics TAXUS SR Control p-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 + 9.9 0.681 Lesion Length (mm) 10.55 + 3.9 10.51 + 4.1 0.931 TCT 2002

  6. TAXUS II: Primary Endpoint, In-stent Net Volume Obstruction at 6 Month IVUS 62% reduction p < 0.0001 % In-stent Net Volume Obstruction n=125 n=118 TAXUS SR Stent Control Stent TCT 2002

  7. TAXUS II: Clinical Events Through 6 Months Target Lesion Revascularization MACE* *Defined as cardiac death, MI, TVR p=0.013 p=0.043 TAXUS SR Stent Control Stent TAXUS SR Stent Control Stent TCT 2002

  8. TAXUS II: 6 Month Angiographic Restenosis Stented Segment p=0.0002 Distal Edge (5 mm) p=0.685 Proximal Edge (5 mm) p=1.000 Restenosis (%) n=134 n=127 Control Stent Control Stent TAXUS SR Stent Control Stent TAXUS SR Stent TAXUS SR Stent TCT 2002

  9. TAXUS II: 6 Month Angiographic MLD Stented Segment p<0.0001 Distal Edge p=0.039 Proximal Edge p=0.009 (mm) n=134 n=127 Control Stent Control Stent TAXUS SR Stent Control Stent TAXUS SR Stent TAXUS SR Stent TCT 2002

  10. TAXUS II: Late Loss and Loss Index in Stented Segment Late Loss Loss Index p<0.0001 p<0.0001 (mm) n=134 n=125 n=134 n=127 TAXUS SR Stent Control Stent TAXUS SR Stent Control Stent TCT 2002

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