SMART Trial

SMall Annuli Randomized To Evolut™ or SAPIEN™*

For small annulus patients, the SMART Trial data are clear: Evolut™ transcatheter aortic valve replacement (TAVR) delivers superior valve performance versus SAPIEN™* platform with excellent early patient outcomes at 1 year.1

About the trial

Evolving TAVR, together.

The SMART Trial was a prospective, multicenter, randomized controlled trial conducted to understand how valve design differences between the Medtronic self-expandable (SE) Evolut™ platform and Edwards Lifesciences balloon-expandable (BE) SAPIEN™* transcatheter aortic valve replacement system affect treatment of small aortic annulus (≤ 430 mm2) patients with symptomatic, severe native-aortic stenosis.

One year late-breaking data confirm that these contemporary TAVs behave differently in this patient group, providing physicians with crucial insights to tailor treatment decisions according to individual patient needs.

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SMART Trial 1-year results

Evolut™ TAVR delivers superior valve performance versus SAPIEN™* platform in small annulus patients with excellent early patient outcomes at 1 year.1

4x less

bioprosthetic valve dysfunction (BVD)

Evolut™ TAVR: 9.4%
SAPIEN™* TAVR: 41.6%

Clinical outcome composite:
All-cause mortality, disabling stroke, or heart failure rehospitalization at 1 year.

Difference, -1.2% (90% CI -4.9%, 2.5%), p < 0.001 for noninferiority
Hazard ratio, 0.90 (95% CI 0.56–1.43)

Evolut™ TAVR is superior at restoring near normal blood flow in small annulus patients

at 1 year versus SAPIEN™*‡1 platform.

3.5x less

≥ moderate PPM at 30 days compared to SAPIEN™* platform.

p < 0.001

Evolut™ TAVR: 10.3%
SAPIEN™* TAVR: 35.1%

10

x less

frequent residual gradients equivalent to pre-AVR moderate AS ≥ 20 mmHg

at 1 year compared to SAPIEN™* platform.

p < 0.001

Evolut™ TAVR: 3.2%
SAPIEN™* TAVR: 32.2%

Making a difference for women

Trial design

Trial endpoints

Learn more about SMART Trial

Heart teams, join us for a live Zoom webinar where expert clinicians will discuss the results from the SMART Trial. Contact your local Medtronic representative to register.

SMART Trial: Implications for real-world practice

Moderator:
Kendra Grubb, M.D.

Presenters:
Howard Herrmann, M.D.
Basel Ramlawi, M.D.
Angela Patti, N.P.

Moderator:
Daniel O’Hair, M.D.

Presenters:
Howard Herrmann, M.D.
Hemal Gada, M.D.
Charnai Sherry, P.A.

Moderator:
Michael Reardon, M.D.

Presenters:
Samer Abbas, M.D.
Guilherme Attizzani, M.D.
Elana Koss, M.D.

Additional information

Visit clinicaltrials.gov for more information on the SMART Trial. Use identifier number NCT04722250 to see details on the trial.

Explore real-world data

The Medtronic CoreValve™/Evolut™ platform is supported by a robust body of clinical evidence. Explore our evidence summaries and real-world data.

Devices used: 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%

™* Third-party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.

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

‡ Valve performance as defined as freedom from bioprosthetic valve dysfunction (BVD) at 12 months. BVD is a composite including any of the following: hemodynamic structural valve dysfunction (mean gradient ≥ 20 mmHg), nonstructural valve dysfunction (severe prothesis-patient mismatch or ≥ moderate aortic regurgitation), thrombosis, endocarditis, and aortic valve reintervention.

§ Please visit clinicaltrials.gov for complete trial information including a list of patient inclusion and exclusion criteria.

1. Herrmann et al. Self-expanding versus balloon-expandable transcatheter aortic valve replacement in patients with small aortic annuli: primary outcomes from the randomized SMART Trial. Presented at ACC; April 2024.

2. Blakemore E. Women are still underrepresented in clinical trials. Washington Post. Published June 24, 2022. Accessed on March 19, 2024.