TAXUS V ISR Trial of Taxus stent vs brachytherapy for in stent restenosis

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TAXUS V ISR Trial of Taxus stent vs brachytherapy for in stent restenosis Powered By Docstoc
					            TAXUS V ISR Trial



Paclitaxel-eluting Stents vs Brachytherapy for
   In-stent Restenosis (TAXUS V ISR) Trial



              Presented at
    The American College of Cardiology
         Scientific Session 2006
      Presented by Dr. Gregg W. Stone
              TAXUS V ISR Trial: Study Design
396 patients > 18 years with stable or unstable angina or inducible ischemia undergoing
            percutaneous coronary intervention (PCI) of a single bare-metal
               in-stent restenosis (ISR) lesion in a native coronary artery.
                                              Randomized.
                         34% female, median age 63 years, mean follow-up 9 months



                                     Angiography (Baseline)


  VBT using a beta-source radiation                             PCI with paclitaxel-eluting stents
               n=201                                                          n=195


                                Repeat Angiography (9 months)
                              170 in VBT group and 172 in Paclitaxel group


            Primary Endpoint: Ischemia-driven target vessel revascularization at 9 months

www. Clinical trial results.org                                                     Presented at ACC 2006
                             TAXUS V ISR Trial: Baseline
            Median time since bare-metal stent (BMS)                                 Target lesion location left anterior
                      implantation (days)                                                  descending (LAD) (%)
                               p=0.43                                                               p=0.23




                                                         percent target lesion LAD
median time since BMS
 implantation (days)




              • Stenosis at baseline was approximately 68% in each group, with a median lesion
                length of approximately 15 mm.




     www. Clinical trial results.org                                                                    Presented at ACC 2006
        TAXUS V ISR Trial: Restenosis Pattern
               Restenosis pattern of target lesion: diffuse vs focal (%)

                          p=0.006



                                                     p=0.02




   • A diffuse pattern of restenosis occurred less often in the VBT group than the
     paclitaxel group (47.0% vs 60.8%; p=0.006)
   • A focal pattern of restenosis occurred more often in the VBT group than the
     paclitaxel group (29.0% vs 18.6%; p=0.02)
www. Clinical trial results.org                                   Presented at ACC 2006
         TAXUS V ISR Trial: Primary Endpoint

       Ischemic Target Vessel Revascularization at 9 months (%)
                                  p=0.046


                                                      • The primary endpoint of
                                                        ischemic target vessel
                                                        revascularization was
                                                        higher in the VBT group
                                                        compared with the
                                                        paclitaxel group at 9
                                                        months (17.5% vs 10.5%;
                                                        p=0.046)




www. Clinical trial results.org                              Presented at ACC 2006
  TAXUS V ISR Trial: 9 month Clinical Results

         Ischemic Target Lesion Revascularization
                     at 9 months (%)
                                  p=0.01

                                                    • Ischemic target lesion
                                                      revascularization was
                                                      higher in the VBT
                                                      group compared with
                                                      the paclitaxel group at
                                                      9 months (13.9% vs
                                                      6.3%; p=0.01)




www. Clinical trial results.org                           Presented at ACC 2006
  TAXUS V ISR Trial: 9 month Clinical Results

                Nonischemic TVR and TLR (%)
                           p=0.01 for both



                                              • Both nonischemic TVR
                                                and TLR were lower
                                                among the paclitaxel
                                                group (6.7% vs 1.6% in
                                                both cases; p=0.01)




www. Clinical trial results.org                     Presented at ACC 2006
  TAXUS V ISR Trial: 9 month Clinical Results

                     Any TVR and TLR (%)



                                                     • Any incident of TVR
                        p=0.003
                                                       was greater among the
                                           p<0.001     VBT group (23.7% vs
                                                       12.0%; p=0.003)

                                                     • Any incident of TLR
                                                       was greater among the
                                                       VBT group (20.1% vs
                                                       7.9%; p<0.001)




www. Clinical trial results.org                           Presented at ACC 2006
  TAXUS V ISR Trial: 9 month Clinical Results

   Target Vessel Thrombosis (cumulative to 9 months) (%)
                                  p=0.72



                                                           There was no differences
                                                           in Target Vessel
                                                           Thrombosis




www. Clinical trial results.org                               Presented at ACC 2006
      TAXUS V ISR Trial: Composite of MACE

  Composite of Any Major Adverse Cardiac Event (MACE) (%)
                                  p=0.02
                                                    • The composite of any
                                                      major adverse cardiac
                                                      event was greater in the
                                                      VBT group compared
                                                      with the paclitaxel group
                                                      (20.1% vs 11.5%; p=0.02)
                                                      and was primarily driven
                                                      by the reduction in TVR

                                                    • There was no difference
                                                      in death (n=1 vs n=0) or
                                                      MI (4.6% vs. 3.7%;
                                                      p=0.63)




www. Clinical trial results.org                             Presented at ACC 2006
                   TAXUS V ISR Trial: 9 month Angiography
                     Late Loss at 9 months (mm)   Minimum Lumen Diameter at 9 months (mm)
                               p=0.08                               p<0.001
  Late loss (mm)




                                                  MLD (mm)
         • A trend toward greater late loss was present in the VBT group (0.22 mm vs 0.13
           mm; p=0.08)

         • A smaller MLD was present in the VBT group in the analysis segment (1.55 mm vs
           1.99 mm; p<0.001)

www. Clinical trial results.org                                           Presented at ACC 2006
                         TAXUS V ISR Trial: 9 month Angiography
                          Binary Restenosis at 9 months (%)     Final post-procedure diameter stenosis in the
                                        p<0.001                             analysis segment (%)
                                                                                         p<0.001




                                                                 Diameter stenosis (%)
Binary restenosis (%)




                        • A higher rate of binary restenosis was present in the VBT group (31.2% vs 14.5%;
                          p<0.001)
                        • The final post-procedure diameter stenosis in the analysis segment was greater for
                          the VBT group (29.3% vs 20.6%; p<0.001)

www. Clinical trial results.org                                                                Presented at ACC 2006
               TAXUS V ISR Trial: Limitations

     • Future studies should take a closer look at the role of
       brachytherapy in the treatment of in-stent restenosis
       of drug-eluting stents.
     • Future trials need to consider the long-term durability
       of drug-eluting stents for the treatment of in-stent
       restenosis.




www. Clinical trial results.org                    Presented at ACC 2006
                 TAXUS V ISR Trial: Summary
 • Among patients with restenotic coronary lesions, treatment with paclitaxel-
   eluting stents was associated with a reduction in ischemic driven target
   vessel revascularization at 9 months compared with vascular
   brachytherapy.
 • Intravascular brachytherapy is the only currently approved treatment for in-
   stent restenosis. However, brachytherapy is complicated to perform and is
   only performed at a limited number of sites. While not approved for ISR,
   drug-eluting stents have been used for the treatment of ISR and the
   present study is now the second large-scale randomized trial to show
   superiority with drug-eluting stents over VBT for treatment of ISR.
 • The SISR study evaluated brachytherapy compared with sirolimus-eluting
   stents for ISR treatment, and showed a reduction in target vessel failure
   with sirolimus-eluting stents.

www. Clinical trial results.org                              Presented at ACC 2006

				
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