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    • SMART Trial 2-year results1

    The SMall Annuli Randomized To Evolut or SAPIEN Trial, or SMART Trial, is a prospective, multi-center, international, randomized controlled trial comparing the Medtronic self-expandable (SE) Evolut™ system versus Edwards Lifesciences balloon-expandable (BE) SAPIEN™* transcatheter aortic valve implantation (TAVI) system in patients with a small aortic annulus (≤ 430 mm2) and symptomatic severe native aortic stenosis. These results emphasize the importance of valve design and its impact on performance.

    Through 2 years, Evolut™ TAVI continued to show superior valve performance† in small annulus patients‡ compared to SAPIEN™* TAVI with sustained excellent patient outcomes.1

    Bioprosthetic valve dysfunction (BVD) through 2 years

    Difference, -35.9% (95% CI -43.0%, -28.7%)
    p < 0.001

    Clinical outcome composite

    All-cause mortality, disabling stroke, or heart failure rehospitalization through 2 years
    HR 1.01 (95% CI 0.71, 1.43) p = 0.97

    Sample size

    N = 716 total
    N = 355 Evolut™ TAVI
    N = 361 SAPIEN™* TAVI

    Devices

    Evolut™ PRO+ 78.0%
    Evolut™ PRO 17.1%
    Evolut™ FX 4.3%
    Evolut™ R 0.6%

     

    SAPIEN™* 3 Ultra 80.8%
    SAPIEN™* 3 19.2%

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    † Valve performance as defined as freedom from BVD through 24 months. BVD is a composite including any of the following: hemodynamic structural valve dysfunction (mean gradient ≥ 20 mmHg), non-structural valve dysfunction (severe PPM or ≥ moderate aortic regurgitation), thrombosis, endocarditis, and aortic valve reintervention.

    ‡ In patients with small annuli (area ≤ 430 mm2) in all-comers trial, consisting of majority low surgical risk participants (52.1%).

    TAVI risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker.

    Evolut™ Low Risk Trial2

    Evolut™ TAVI shows excellent outcomes in low-risk patients, with a 26% reduction in hazard for death or disabling stroke at 4 years.

    All-cause mortality or disabling stroke

    Sample size

    N = 730 TAVI, N = 684 SAVR

    Devices

    Evolut™ R 73%/Evolut™ PRO 23.4%/CoreValve™ 3.6%

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    TAVI risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker.


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    Impact of a standardized TAVI technique and care pathway in the Optimize PRO study3

    The cusp overlap technique, with an optimized care pathway, demonstrated excellent clinical outcomes in this analysis with consistently low pacemaker rates (11.1% PPI at 30 days overall, 6.4% PPI with 4-step cusp overlap technique adherence/compliance) and low rates of PVL (0% moderate/severe at discharge).

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    Paravalvular leak (PVL) at discharge

    n = 618

    TAVI risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker.


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    CoreValve™ and Evolut™ pooled analysis: 5-year incidence of BVD4

    CoreValve™/Evolut™ TAVI had significantly better valve performance than surgery as assessed by BVD at 5 years,§ with three times lower severe prosthesis-patient mismatch (PPM) at 30 day/discharge in randomized clinical trials. (3.7% CoreValve™/Evolut™ TAVI versus 12.1% SAVR; p < 0.001).

     

    CoreValve™/Evolut™ TAVI demonstrated significantly lower rates of BVD versus SAVR (9.6% CoreValve™/Evolut™ TAVI versus 15.4% SAVR; p < 0.001).

    BVD out of 5 years

    Sample size

    N = 2,295

    Devices

    CoreValve™ 89%/Evolut™ R 11%

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    § BVD was defined as5,6: SVD7 (mean gradient ≥ 10 mmHg increase from discharge/30 days AND ≥ 20 mmHg at last echo or new onset/increase of ≥ moderate intraprosthetic aortic regurgitation), NSVD (30-day severe PPM at 30-day/discharge or severe PVR through 5 years), clinical valve thrombosis, and endocarditis.

    TAVI risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker.


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    SURTAVI 5-year Trial8

    Compared to SAVR at five years, CoreValve™/Evolut™ TAVI demonstrated no statistical difference in all-cause mortality (30.0% TAVI versus 30.8% SAVR; p = 0.85), numerically lower disabling stroke (4.1% TAVI versus 5.8% SAVR; p = 0.12), and statistically better hemodynamics with stable low gradients in intermediate-risk patients.

    Mean gradient and EOA over time implanted set

    Sample size

    N = 864 TAVI, N = 796 SAVR

    Devices

    CoreValve™ 84%/Evolut™ R 16%

    TAVI risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker.


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    Real-world results

    Review recent data that reinforces the excellent outcomes seen in our Medtronic clinical trials.

    Explore the data

    Procedure and performance

    Discover our procedural guidance and outcomes you can expect from the Evolut™ platform.

    Explore the technique

    Build your knowledge.

    Medtronic Academy offers a wide range of resources for the Evolut™ TAVI platform.

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