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Tct 2010 partner lbct press conference 092310

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  • 1. Press Conference
    Transcatheter Aortic Valve Implantation in Inoperable Patients with Severe Aortic Stenosis
    Martin B. Leon, MD
    on behalf of the
    PARTNER Investigators
    TCT 2010; Washington, DC; September 23, 2010
  • 2. PARTNER Study Design
    Total = 1058 patients
    n=358
    n= 700
    2 Parallel Trials: Individually Powered
    High Risk
    Inoperable
    ASSESSMENT: Transfemoral Access
    ASSESSMENT: Transfemoral Access
    High Risk TA
    High Risk TF
    1:1 Randomization
    1:1 Randomization
    1:1 Randomization
    Not In Study
    TAVI
    Trans
    femoral
    Surgical AVR
    Standard Therapy
    (usually BAV)
    TAVI
    Trans
    femoral
    Surgical AVR
    TAVI
    Trans
    femoral
    VS
    VS
    VS
    Primary Endpoint: All Cause Mortality (1 yr)(Non-inferiority)
    Primary Endpoint: All Cause Mortality over length of trial (Superiority)
    Symptomatic Severe Aortic Stenosis
    ASSESSMENT: High Risk AVR Candidate
    3105 Total Patients Screened
  • 3. Primary and Co-Primary Endpoints
    PRIMARY: All-cause mortality over the duration of the study
    Superiority test (two-sided), 85% power to detect a difference, α = 0.05, sample size = 350 total patients
    CO-PRIMARY: Hierarchical composite of all-cause mortality and repeat hospitalization
    Non-parametric method described by Finkelstein and Schoenfeld (multiple pair-wise comparisons)
    > 95% power to detect a difference, α = 0.05
    Positive study if both endpoints P < 0.05, or if either endpoint is < 0.025
  • 4. Study Devices
    Retroflex 1
    Edwards-SAPIEN THV
    23mm and 26mm
    valve sizes
    22F and 24F
    sheath sizes
  • 5. Inclusion Criteria
    Severe calcific aortic stenosis defined as echo derived valve area of < 0.8 cm2(EOA index <0.5cm2), and mean gradient > 40 mmHg or jet velocity > 4.0 m/s
    NYHA functional class II or greater
    Risk of death or serious irreversible morbidity as assessed by cardiologist and two surgeons must exceed 50%
  • 6. All Cause Mortality
    Standard Rx
    TAVI
    HR [95% CI] =0.54 [0.38, 0.78]
    P (log rank) < 0.0001
    All-cause mortality (%)
    Months
  • 7. All Cause Mortality
    Standard Rx
    ∆ at 1 yr = 20.0%NNT = 5.0 pts
    TAVI
    50.7%
    All-cause mortality (%)
    30.7%
    Months
  • 8. Finklestein & Schoenfeld Analysis(hierarchical multiple pair-wise comparison)
    Compare, at random, every TAVI patient with every Standard Rx patient; 179 x 179 (32,041) patient pairs, which did better?
    #1, compare “time to death”
    72% chance that we know who died first
    If so, 63% chance that Standard Rx patient died first and 37% chance that TAVI patient died first
    #2, if necessary, compare “time to repeat hospitalization”
    17% chance that we know who had repeat hosp first
    If so, 75% chance that Standard Rx patient had repeat hosp first and 25% chance that TAVI patient had repeat hosp first
    FS Method
    Produces a P-value
    < 0.0001
  • 9. Clinical Outcomes at 30 Days & 1 Year
  • 10. Clinical Outcomes at 30 Days & 1 Year
  • 11. Six-Minute Walk Tests
    Walking Distance
    P = 0.002
    P = 0.67
    P = 0.004
    P = 0.55
    Walking distance (meters)
    Baseline
    1 Year
    30 Days
  • 12. Percent
    TAVI
    Standard Rx
    TAVI
    Standard Rx
    TAVI
    Standard Rx
    TAVI
    Standard Rx
    Treatment
    Visit
    Baseline
    30 Day
    6 Month
    1 Year
    NYHA Class Over TimeSurvivors
    P = 0.68
    P < 0.0001
    P < 0.0001
    P < 0.0001
    I
    II
    III
    IV
  • 13. Standard Rx
    70
    TAVI
    44.6
    44.4
    60
    39.5
    50
    33.0
    40
    Mean Gradient (mm Hg)
    30
    43.2
    12.1
    11.3
    10.8
    20
    10
    0
    Mean Gradients Over Time
    P < 0.0001
    6 Months
    N=100
    1 Year
    N=89
    Baseline
    N=163
    30 Day
    N=143
    Error bars = ± 1 Std Dev
  • 14. 30 Day
    6 Month
    1 Year
    Paravalvular Regurgitation: TAVI
    No changes over time
    None/Trace
    Moderate
    Mild
    Severe
  • 15. Conclusions - 1
    In patients with severe AS and symptoms, who are not suitable candidates for surgery…
    • Standard therapy (including BAV in 83.8% of pts) did not alter the dismal natural history of AS; all-cause and cardiovascular mortality at 1 year was 50.7% and 44.6% respectively
    • 16. Transfemoral balloon-expandable TAVI, despite limited operator experience and an early version of the system, was associated with acceptable 30-day survival (5% after randomization in the intention-to-treat population)
  • Conclusions - 2
    • TAVI was superior to standard therapy, markedly reducing the rate of…
    • 17. all-cause mortality by 46%, P < 0.0001, NNT = 5.0 pts
    • 18. cardiovascular mortality by 61%, P < 0.0001, NNT = 4.1 pts
    • 19. all-cause mortality and repeat hospitalization
    • 20. hierarchical (FS method), P < 0.0001
    • 21. non-hierarchical (KM analysis) by 54%, P < 0.0001, NNT = 3.4 pts
  • Conclusions - 3
    • TAVI improved cardiac symptoms (NYHA class, P < 0.0001) and six minute walking distance (P = 0.002), after 1-year follow-up
    • 22. TAVI resulted in more frequent complications at 30 days, including…
    • 23. major vascular complications, 16.2% vs. 1.1%, P < 0.0001
    • 24. major bleeding episodes, 16.8% vs. 3.9%, P < 0.0001
    • 25. major strokes, 5.0% vs. 1.1%, P = 0.06
  • Conclusions - 4
    • Serial echocardiograms in TAVI patients indicated…
    • 26. reduced mean gradients (P < 0.0001) which were unchanged during 1-year FU
    • 27. frequent paravalvular AR, which was usually trace or mild (~90%), remained stable during 1-year FU, and rarely required further Rx.
  • Clinical Implications
    • Balloon-expandable TAVI should be the new standard of care for patients with aortic stenosis who are not suitable candidates for surgery!
    • 28. Next generation devices (e.g. SAPIEN XT) may help to reduce the frequency of procedure-related complications in the future.
    • 29. The ultimate value of TAVI will depend on careful assessment of bioprosthetic valve durability, which will mandate obligatory long-term clinical and echocardiography FU of all TAVI patients.
  • September 22, 2010 on NEJM.org