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					            ZOMAXX-IVUS Trial


Percutaneous Coronary Revascularization Using a
 Trilayer Phosphorylcholine-coated Zotarolimus-
         eluting Stent (ZoMaxx IVUS) Trial


                Presented at
      The American College of Cardiology
           Scientific Session 2006
           Presented by Dr. A. Abazid
             ZOMAXX-IVUS Trial: Background


 • This is a first in-man study evaluating the clinical and angiographic
   findings using the Phosphorylcholine-coated Zotarolimus-eluting
   stent.


 • This trial was designed to assess the rates of angiographic
   restenosis associated with percutaneous coronary
   revascularization using the Zotarolimus-eluting stent.




www. Clinical trial results.org                          Presented at ACC 2006
            ZOMAXX-IVUS Trial: Study Design

   40 patients with symptomatic ischemic coronary occlusive disease due to single de
                               novo obstructive lesions
                         45% female, mean age 59 years, mean follow-up 4 months




                          All patients underwent percutaneous
                          coronary intervention (PCI) using the
                              3.5 mm x 18 mm Zomaxx stent



           Primary Endpoint: Percent in-stent net volume obstruction at 4 months
           Secondary Endpoint: Individual and combined endpoints including death,
            myocardial infarction, ischemia driven revascularization



www. Clinical trial results.org                                                   Presented at ACC 2006
             ZOMAXX IVUS Trial: Primary Endpoint
         Reduction in Diameter Stenosis (%)                Acute Gains (mm)
                                   19±7%                  1.86±0.34 mm        1.48±0.38 mm
    25                                             2.00

    20
                                                   1.50
    15         5.1±5.3%




                                              mm
%




    10                                             1.00

     5
                                                   0.50
     0

    -5                                             0.00
                In-Stent         In-Segment                In-Stent            In-Segment
     • In-stent and in-segment diameter stenoses were reduced to 5.1±5.3% and 19.0±7.0%
     respectively.
     • In-stent and in-segment acute gains were 1.86±0.34 mm and 1.48±0.38 mm.
     • There were no major adverse cardiac events (MACE) during the study (MACE: composite
     endpoint of non-Q wave MI, Q-wave MI, ischemia target vessel revascularization and
     cardiac death).
www. Clinical trial results.org                                          Presented at ACC 2006
              ZOMAXX IVUS Trial: Angiographic Endpoints at
                              4-Months
         Reduction in Diameter Stenosis (%)                      Late Loss (mm)
                        n=37                                          n=37
                                                  0.6       0.20±0.35 mm
    40                             23.0±13%                                       0.17±0.35 mm
    35                                            0.5
                                                  0.4




                                                 mm
    30
%




    25         10.0±14%                           0.3
    20                                            0.2
    15
                                                  0.1
    10
                                                  0.0
     5
     0                                           -0.1
    -5                                           -0.2
               In-Stent           In-Segment                  In-Stent            In-Segment

    • In a total of 37 patients, in-stent and in-segment diameter stenosis (DS) was 10.0±14% and
    23.0±13% respectively.
    • In-stent and in-segment late loss was 0.20±0.35 mm and 0.17±0.35 mm.


www. Clinical trial results.org                                             Presented at ACC 2006
      ZOMAXX-IVUS Trial: Angiographic Endpoints at 4-
                     Months (cont.)


     • There were no lesion, procedure, and device-
       deployment failures.
     • One patient had a diameter stenosis of 55%.
     • The binary restenosis rate was 5.4%.
     • There was no evidence of angiographic edge
       restenosis.




www. Clinical trial results.org                Presented at ACC 2006
 ZOMAXX IVUS Trial: Angiographic Endpoints at 4-Months
                        (cont.)
                 Late Loss Rate (mm)

     0.40
                                             • The late loss rate in
                                    0.30       non-diabetic patients
     0.30                                      and diabetic patients
                                               was 0.14 mm and 0.30
mm




                                               mm respectively.
     0.20
                     0.14
     0.10

     0.00
              Non-Diabetic        Diabetic
                Patients          Patients
www. Clinical trial results.org                     Presented at ACC 2006
              ZOMAXX-IVUS Trial: Limitations

     • Randomized data vs an active control comparator
       will be needed to make an evaluation regarding
       relative efficacy.




www. Clinical trial results.org               Presented at ACC 2006
               ZOMAXX-IVUS Trial: Summary

 • The clinical and angiographic findings in this first in man
   study of a phosphorylcholine-coated Zotarolimus-eluting
   stent appear comparable with initial studies of other
   rapamycin and rapamycin analogs.
 • Follow-up studies incorporating angiographic follow-up
   beyond 4 months as well as the results of the randomized
   ZoMaxx-1 study will provide additional data to expand
   upon these initial registry findings.



www. Clinical trial results.org                   Presented at ACC 2006

				
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