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Overview

For small annulus† patients, the SMART Trial data are clear: Evolut™ transcatheter aortic valve replacement (TAVR) delivers superior valve performance‡ versus SAPIEN™* TAVR with excellent patient outcomes through 2 years.1

About the trial

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.

The latest data reported through two years reinforce that these contemporary TAVs behave differently in this patient group, providing physicians with crucial insights to tailor treatment decisions according to individual patient needs.

SMART Trial 2-year results

Evolut™ TAVR maintains superior valve performance‡ vs. SAPIEN™* TAVR in small annulus patients.†,1

Significantly less BVD‡

with Evolut™ TAVR

vs. SAPIEN™* TAVR in small annulus patients†,1

p < 0.001


Evolut™ TAVR: 12.5%
SAPIEN™* TAVR: 48.4%


Sustained
excellent patient outcomes through 2 years.1

Evolut™ TAVR: 17.8%
SAPIEN™* TAVR: 17.6%. p = 0.97
Hazard ratio, 1.01 (95% CI 0.71, 1.43)

Clinical outcome composite: All-cause mortality,
disabling stroke, or heart failure
rehospitalization

Compared to SAPIEN™* TAVR, only Evolut™ TAVR continues to show strong results across these key components of valve performance‡:

4.5x less

prosthetic valve thrombosis§

through 2 years in small annulus patients†,1

p = 0.0048


Evolut™ TAVR: 1.0%
SAPIEN™* TAVR: 4.5%


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

9x less

HSVD◊ (mean gradient ≥ 20 mmHg)

through 2 years in small annulus patients†,1

p < 0.001


Evolut™ TAVR: 4.7%
SAPIEN™* TAVR: 42.4%


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

Evolut™ TAVR in women

Only Evolut™ TAVR design has superior valve performance for women compared to SAPIEN™* TAVR at one year.¶,2

Women’s hearts are different and so is their AS journey. While women are typically underrepresented in major clinical trials,3 the SMART Trial enrolled predominantly women due to its focus on small annulus patients. The SMART Trial is the largest, randomized controlled TAVR trial to primarily enroll women — providing important clinical insights into this patient population.
 

Drs. Sabine Bleiziffer, Renuka Jain, Roxana Mehran, and Puja Parikh examine the significant healthcare challenge that is the underdiagnosis, under-referral, and undertreatment of women with aortic stenosis.

Read their thoughts on how we address this, what role the heart team plays, and how the groundbreaking SMART Trial is making a difference.

Check out the current supplement issue of Cardiac Interventions Today.

Download the supplement (open in new window)
This an image showing an illustration of a Cardiac Interventions Today supplement cover about women with aortic stenosis.

Get additional information.

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

Learn more about the trial (open in new window)

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.

Discover now

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