SMART Trial
SMall Annuli Randomized To Evolut™ or SAPIEN™*
Through 2 years, Evolut™ TAVI maintains superior valve performance† vs. SAPIEN™* TAVI in small annulus patients‡1
SMART Trial 2-year results
SMART Trial 2-year results
Evolut™ TAVI maintains superior valve performance† vs. SAPIEN™* TAVI in small annulus patients.‡1
Significantly less BVD†
with Evolut™ TAVI
vs. SAPIEN™* TAVI in small annulus patients.‡,1
p < 0.001
Clinical outcome composite:
All-cause mortality, disabling stroke, or heart failure rehospitalization at 2 year.
Evolut™ TAVI: 17.8%
SAPIEN™ TAVI: 17.6%
p = 0.97
Hazard ratio, 1.01 (95% CI 0.71, 1.43)
Compared to
SAPIEN™* TAVI
only Evolut™ TAVI delivers:
4.5x less
prosthetic valve thrombosis§
through 2 years in small annulus patients.‡1
p = 0.0048
Evolut™ TAVI continues to show strong results across these key components of valve performance.
9
x less
HSVD||
(Mean gradient ≥ 20 mmHg)
through 2 years in small annulus patients.‡1
p < 0.001
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%
† Valve performance as defined as freedom from bioprosthetic valve dysfunction (BVD) through 24 months. BVD is defined as a composite including any of the following: hemodynamic structural valve dysfunction (mean gradient ≥ 20 mmHg), non-structural valve dysfunction (severe prothesis-patient mismatch or ≥ moderate aortic regurgitation), clinical 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%).
§ Prosthetic valve thrombosis as defined as a composite of clinical and sub-clinical valve thrombosis.
|| Hemodynamic structural valve dysfunction.
1. Herrmann H, et al. SMART 2 Year Data Update. Presented at CRT; March 2025.
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