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TAXUS Slow Release Data

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

                                  Presented at TCT 2002




www. Clinical trial results.org
                          TAXUS II: Study Overview


   • Randomized 1:1                    Inclusion Criteria
   • Triple-blind                      • Standard risk de novo
   • 536 Patients                      lesions
        TAXUSTM NIRxTM SR             • Length <12 mm
       (n=267)                         • RVD >3.0 mm & <3.5 mm
        TAXUSTM NIRxTM MR
       (n=269)                         Antiplatelet Regimen
   • 30 day, 6 month, 1-5 year F/U     •ASA >75 mg (loading dose and
   • Primary endpoint: % in-stent      maintained indefinitely)

   net volume obstruction (IVUS)       •Clopidogrel (loading dose 300mg and 75
                                       mg q.d. for 6 months)
   at 6 m

www. Clinical trial results.org                                     TCT 2002
         TAXUS II: Two Consecutive Cohorts, Slow and
                      Moderate Release

     Slow Release (SR)                        Moderate Release (MR)
             Cohort I               DMC                 Cohort II
             SR = 267                                   MR = 269

   TAXUS              Control                 TAXUS             Control
   n = 131            n = 136                 n = 135           n = 134

                                   30 Day
                                  Follow-up
            SR Follow-up                              MR Follow-up
           Clinical: >99%                             Clinical: >96%
                                   6 Month
      Angiographic: >98%          Follow-up      Angiographic: >95%
              IVUS: >90%                                 IVUS: >87%

                                  Annually
www. Clinical trial results.org   1-5 Years                         TCT 2002
                   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


www. Clinical trial results.org                                TCT 2002
           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




www. Clinical trial results.org                               TCT 2002
      TAXUS II: Primary Endpoint, In-stent Net Volume
                Obstruction at 6 Month IVUS

                                                   30
               % In-stent Net Volume Obstruction
                                                                          23.2

                                                   20    62% reduction
                                                           p < 0.0001




                                                   10     7.9



                                                         n=118            n=125
                                                   0
                                                        TAXUS SR         Control
                                                          Stent           Stent
www. Clinical trial results.org                                                    TCT 2002
          TAXUS II: Clinical Events Through 6 Months

        Target Lesion Revascularization                   MACE*
                                                *Defined as cardiac death, MI, TVR
  30%                                     30%
              p=0.043                               p=0.013

                                                                        19.5%
  20%                                     20%

                            12.0%
                                          10%      8.5%
  10%
             4.6%


   0%                                     0%
          TAXUS SR         Control              TAXUS SR               Control
            Stent           Stent                 Stent                 Stent
www. Clinical trial results.org                                               TCT 2002
                         TAXUS II: 6 Month Angiographic Restenosis


                       Proximal Edge (5 mm)    Stented Segment      Distal Edge (5 mm)
                            p=1.000                p=0.0002             p=0.685
                 20
                                                         17.9
Restenosis (%)




                 15


                 10


                 5
                                                                                3.0
                                  2.2           2.3
                        1.6                                           1.6
                                               n=127     n=134
                 0
                      TAXUS SR   Control      TAXUS SR   Control   TAXUS SR   Control
                        Stent     Stent         Stent     Stent      Stent     Stent

           www. Clinical trial results.org                                      TCT 2002
                      TAXUS II: 6 Month Angiographic MLD


                 Proximal Edge            Stented Segment        Distal Edge
                    p=0.009                   p<0.0001             p=0.039
        3

              2.40
                         2.23             2.23                  2.19
                                                                         2.07
        2                                           1.79
(mm)




        1



                                          n=127     n=134
        0
            TAXUS SR    Control          TAXUS SR   Control   TAXUS SR   Control
              Stent      Stent             Stent     Stent      Stent     Stent

       www. Clinical trial results.org                                    TCT 2002
               TAXUS II: Late Loss and Loss Index in Stented Segment


                            Late Loss                 Loss Index

         1.0                                1.0
                    p<0.0001        0.79             p<0.0001
(mm)




                                                                   0.53
         0.5                                0.5
                    0.31
                                                    0.22


                    n=127           n=134           n=125          n=134
         0.0                                0.0
                 TAXUS SR         Control         TAXUS SR      Control
                   Stent           Stent            Stent        Stent
       www. Clinical trial results.org                                TCT 2002

								
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