Key Studies - Transcatheter Aortic Valve Replacement

Medtronic key studies

Stay up to date on the latest clinical evidence from Medtronic. Key summaries demonstrate the efficacy of the CoreValve™/Evolut™ TAVR platform.

Download the Medtronic clinical trial overview brochure.

Evolut™ Low Risk Trial¹

Evolut™ TAVR shows durable clinical outcomes in low-risk patients at five years.¹

5-year all-cause mortality or disabling stroke in Evolut™ Low Risk Trial

This chart shows the five-year all-cause mortality or disabling stroke results from the Evolut™ Low Risk Trial.

Sample size

N = 730 TAVR, N = 684 SAVR

Devices

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

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

SMART Trial 2-year results²

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 replacement (TAVR) 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™ TAVR continued to show superior valve performance^† in small annulus patients^‡ compared to SAPIEN™* TAVR with sustained excellent patient outcomes.²

Bioprosthetic valve dysfunction (BVD) through 2 years

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

This illustration shows the SMART Trial two-year bioprosthetic valve dysfunction (BVD) data for Evolut™ versus SAPIEN™* transcatheter aortic valves (TAV).

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

This chart shows the two-year all-cause mortality, disabling stroke, or heart failure rehospitalization results from the SMART trial.

Sample size

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

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%).

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

Impact of a standardized TAVR 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

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

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

CoreValve™/Evolut™ TAVR 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™ TAVR versus 12.1% SAVR; p < 0.001).

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

BVD out of 5 years

This is a chart for bioprosthetic valve dysfunction at five years between surgery and CoreValve™ Evolut™ transcatheter aortic valve replacement.

Sample size

N = 2295

Devices

CoreValve™ 89%/Evolut™ R 11%

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§ BVD was defined as^5,6: 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.

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

SURTAVI 5-year Trial⁸

Compared to SAVR at five years, CoreValve™/Evolut™ TAVR demonstrated no statistical difference in all-cause mortality (30.0% TAVR versus 30.8% SAVR; p = 0.85), numerically lower disabling stroke (4.1% TAVR 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

This graph shows the SURTAVI five-year results on the Medtronic transcatheter aortic valve replacement or implantation platform, depending on country or region, for intermediate-risk patients.

Sample size

N = 864 TAVR, N = 796 SAVR

Devices

CoreValve™ 84%/Evolut™ R 16%

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

Real-world results

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

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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™ TAVR platform.

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Medtronic key studies

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Real-world results

Procedure and performance

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Medtronic key studies

Evolut™ Low Risk Trial

Sample size

Devices

SMART Trial 2-year results

Sample size

Devices

Optimize PRO global study results

CoreValve™ and Evolut™ pooled analysis

Sample size

Devices

SURTAVI 5-year Trial

Sample size

Devices

Real-world results

Procedure and performance

Build your knowledge.

Related products

United States

Customer Care Team