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									    The SOS (Stenting Of
   Saphenous vein grafts)
Randomized, Controlled Trial of
a Paclitaxel-Eluting Stent Vs. a
  Similar Bare Metal Stent in
Saphenous Vein Graft Lesions

 Emmanouil S. Brilakis, MD, PhD
Director, Cardiac Catheterization Laboratory
    VA North Texas Healthcare System
    On behalf of the SOS investigators
Disclosure Statement of Financial Interest


I, Emmanouil Brilakis DO NOT have a
financial interest/arrangement or affiliation
with one or more organizations that could
be perceived as a real or apparent conflict
of interest in the context of the subject of
this presentation.
              Funding

• Veteran Affairs, VISN-17
• Clark R. Gregg fund, Harris Methodist
 Foundation, Fort Worth, Texas
                   SOS design

•   DESIGN: Prospective, randomized, multi-center trial
    comparing the Taxus™ paclitaxel-eluting stent (PES)
    with a similar Express2™ bare metal stent (BMS) in
    saphenous vein graft (SVG) lesions

•   OBJECTIVE: To compare the 12-month angiographic
    and 24-month clinical outcomes between PES and
    BMS in SVG lesions

•   PRINCIPAL INVESTIGATOR: Emmanouil S. Brilakis,
    MD, PhD. VA North Texas Healthcare System, Dallas,
    Texas
 SOS: sample size determination


• 31 patients needed per group to have
  80% power (2-sided alpha 0.05) to detect
  a 66% reduction in binary angiographic
  restenosis assuming 50% restenosis in
  BMS group and 1 lesion treated per pt

• Target enrollment: 40 patients per group
  to account for losses during follow-up
               SOS: Patient flow
            80 patients (112 lesions) enrolled between
             2005 and 2007 in 5 clinical sites in USA
                            and Europe



         BMS                                          PES
        39 pts                                       41 pts
      55 lesions                                   57 lesions
                                                                Died: 4 pts
                   Died: 1 pt
                                                                Emergent CABG: 1 pt
                   Declined: 5 pts
                                                                Declined: 3 pts

Angiographic follow-up                      Angiographic follow-up
     at 12 months                                at 12 months
         33 pts                                      33 pts
      47 lesions                                  43 lesions

                   Died: 1 pt                                   Died: 1 pt


  Clinical follow-up                         Clinical follow-up
    at 24 months                               at 24 months

                     median follow-up: 18 months
                     SOS trial centers
                                                      Onassis Cardiac Surgery Ctr
                           Little Rock VAMC           Athens, Greece
       Iowa City VAMC      •Joe K. Bissett, MD        •Vassilios Voudris, MD
       •James Rossen, MD   •Rajesh Sachdeva, MD       •Panagiotis Karyofillis, MD




                     VA North Texas HCS
                     Coordinating Ctr
Michael E. DeBakey   •Emmanouil Brilakis, MD, PhD
VAMC                 •Subhash Banerjee, MD                    Collaborators:
•Biswajit Kar, MD    •Christopher Lichtenwalter, MD           Peter Berger, MD
                     •James de Lemos, MD                      Panayotis Fasseas, MD
                     •Owen Obel, MD
                     •Michele Roesle, RN
        Baseline characteristics I

                       BMS      PES        P
                      n = 39   n = 41   Value
Age (yrs)             67± 9    66 ± 9    0.71
Men (%)                100      100       1.0
White (%)               90       98      0.19
Diabetes (%)            44       44      0.98
Current smoker (%)      23       29      0.53
Hypertension (%)        95       93      0.69
Hyperlipidemia (%)      95       98      0.53
        Baseline characteristics II

                         BMS      PES
                                        P Value
                        n = 39   n = 41
Years since CABG        12 ± 6   11 ± 6  0.84
Presentation                             0.53
  - Stable angina (%)     33       29
  - ACS (%)               57       63
BMI (kg/m2)             29 ± 4   30 ± 5  0.32
Prior MI (%)              59       56    0.79
Normal ejection
                         61       51     0.53
fraction (%)
          Procedural description I

                             BMS      PES
                                            P Value
                            n = 39   n = 41
SVG recipient vessel                         0.37
 - LAD/diagonal (%)           30      27
 - Circumflex/OM (%)          30      44
 - RCA/PDA (%)                40      29
Lesion location                              0.80
 - Aortic anastomosis (%)     27      26
 - Body (%)                   66      67
 - Distal anastomosis (%)     7        7
          Procedural description II

                               BMS         PES       P
                              n = 39      n = 41   Value
Number of SVGs treated                    1.12 ±
                            1.15 ± 0.37            0.68
                                           0.33
Number of lesions treated                 1.39 ±
                            1.41 ± 0.64            0.89
                                           0.70
Number of stents/lesion                   1.09 ±
                            1.13 ± 0.34            0.50
                                           0.29
Predilatation (%)               29          33     0.63
Embolic protection (%)          56          51     0.56
Max balloon diameter, mm                  3.30 ±
                            3.20 ± 0.48            0.40
                                           0.52
           Procedural description III

                               BMS        PES         P
                              n = 39     n = 41     Value
Heparin (%)                     79         83       0.69
GP IIb/IIIa inhibitors (%)      13         10       0.66
Contrast, mL                 257 ± 105   262 ± 98   0.84
Fluoroscopy, min              20 ± 9     21 ± 11    0.64


Post PCI MI (%)                 7           6       0.87
Procedural success (%)          97         95       0.59
                   Late Loss
     BMS (47 lesions), PES (43 lesions)



     ± 1.03
                               ± 0.98

mm



                ± 0.57
                                        ± 0.54




     Diff (95% CI)          Diff (95% CI)
     -0.87 (-0.51, -1.22)   -0.81 (-0.48, -1.46)
     P<0.0001               P<0.0001
    Binary angiographic restenosis
        Primary study endpoint




%




              relative risk: 0.18
              95% CI: 0.07, 0.48
                  p < 0.0001
     Cumulative frequency distribution curves
    100

              Before intervention

    75
                                                      BMS
                                                      PES

%   50



    25



     0
          0              1         2        3         4
                        Minimum lumen diameter (mm)
     Cumulative frequency distribution curves
    100

              Before intervention

    75
                                                            BMS
                                                            PES

%   50


                                          After intervention
    25                                    (in-stent minimum lumen
                                          diameter)




     0
          0              1         2        3               4
                        Minimum lumen diameter (mm)
   Cumulative frequency distribution curves
 100



  75
                                                       BMS
                    Follow-up
                                                       PES
                    BMS

% 50
                                  After intervention


  25
                  Follow-up
                  PES


   0
       0            1         2       3         4
           In-stent minimum lumen diameter (mm)
                Clinical outcomes
          median follow-up: 1.5 years
                               BMS      PES
                                              P Value
                              n = 39   n = 41
Death (%)                       5       12     0.27
Myocardial infarction (%)       31      15     0.10
TLR (%)                         28      5      0.003
TVR (%)                         31      15     0.08
Any revascularization (%)       41      20     0.02
Target vessel failure (%)       46      22     0.03
Overall MACE (%)                49      37     0.20
ARC definite/probable stent
                                13       2     0.07
thrombosis (%)
                                  Death from any cause
                   60
                   50
   % of Patients




                   40            Hazard ratio, 1.56
                   30            P=0.27
                   20                                                      SBO
                                                                                      PES
                                                                 Lung CA
                                                       Stroke
                   10                           COPD                   unknown
                            MI       MI
                                                                                      BMS
                    0
                        0                 0.5               1                1.5            2
                                                Years from stenting
No. at risk
     BMS                39                37                31                   22         12
     PES                41                40               34                    19         12
                              Myocardial infarction
                   60
                   50
   % of Patients




                             Hazard ratio, 0.67
                   40
                             P=0.10
                   30                                          BMS

                   20
                   10                                           PES

                    0
                        0          0.5            1       1.5         2
                                         Years from stenting
No. at risk
     BMS                39         30             23       15         10
     PES                41         39             30       15             8
                        Target lesion revascularization
                   60
                   50
   % of Patients




                   40        Hazard ratio, 0.38                BMS
                   30        P=0.003
                   20
                   10
                                                               PES
                    0
                        0          0.5            1       1.5        2
                                         Years from stenting
No. at risk
     BMS                39         33             23       13            8
     PES                41         40             32       17        10
                              Target vessel failure
                               Cardiac death, MI, TVR
                 60
                 50                                            BMS
 % of Patients




                 40       Hazard ratio, 0.65
                          P=0.03
                 30
                 20                                            PES

                 10
                  0
                      0           0.5          1         1.5         2
                                        Years from stenting
No. at risk
  BMS 39                          28           19         11         6
  PES 41                          38           27         13         7
                               Clopidogrel use


                100       98            P=NS
% of Patients




                                       82
                80        89
                                                      68
                                       74
                60                                    64        58
                                                                50
                40

                20

                  0
                      6 months    12 months    18 months   24 months
                                      PES       BMS
              Conclusions

In saphenous vein graft lesions, compared
  to a similar bare metal stent, the Taxus™
  PES resulted in:

• Significant reduction in 12-month binary
 angiographic restenosis, target lesion
 revascularization and target vessel failure
• Trends for lower target vessel
 revascularization, myocardial infarction
• No difference in mortality and stent
 thrombosis

								
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