The SMall Annuli Randomized To Evolut or SAPIEN Trial, or SMART Trial, is a prospective, multicenter, 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 three years, Evolut™ TAVR maintains superior valve performance† vs. SAPIEN™* TAVR in small annulus patients.‡,1
More than 1 in 2 patients† are expected to experience BVD‡
with SAPIEN™* TAVR
within 3 years1
p < 0.001
Evolut™ TAVR: 16.3%
SAPIEN™* TAVR: 54.4%
Sustained excellent patient outcomes through 3 years1
† Valve performance as defined as freedom from bioprosthetic valve dysfunction (BVD) through 36 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 of 716 patients, 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.
Evolut Low Risk Trial 6-year results2
The Evolut Low Risk Trial continues to support the safety and efficacy of Evolut™ TAVR.1 At six years, Evolut TAVR shows no significant difference in all-cause mortality, disabling stroke, or cardiovascular mortality versus SAVR.2
Higher reintervention rates were observed (5.5% Evolut TAVR versus 3.3% SAVR, p = 0.07).2 Reintervention after TAVR was not associated with increased mortality. Seven-year outcomes and reintervention data are available for 76.0% of TAVR patients and 70.2% of SAVR patients. See full data for more information.
No significant difference in
all-cause mortality
or disabling stroke versus SAVR.2
No significant difference in cardiovascular mortality
versus SAVR.2
TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker.
Optimize PRO global study3,4
Adherence to the four-step cusp overlap technique (COT) demonstrated improved permanent pacemaker implantation (PPI) rates compared to nonadherence to the COT technique. At 30 days, the PPI rate with four-step COT was 6.4%; without COT adherence, it was 18.5% (p < 0.001).3
The cusp overlap technique, with an optimized care pathway, demonstrated excellent clinical outcomes in this analysis with low PPI rates at 30 days3 and no moderate/severe paravalvular leak at one year.4
Improved pacemaker rate with COT adherence3 at 30 days
p < 0.001
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 BVD5
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 was defined as6,7: SVD8 (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 Trial 5-year results9
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
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.
TM* Third-party brands are trademarks of their respective owners.
Herrmann H. Three-Year Outcomes of the SMART Trial. Presented at: EuroPCR 2026; May 20, 2026; Paris, France.
Forrest, J, Yakubov, S, Deeb, G. et al. Six-year outcomes after transcatheter vs surgical aortic valve replacement in low-risk patients with aortic stenosis. J Am Coll Cardiol. Published online February 16, 2026. https://doi.org/10.1016/j.jacc.2026.02.506
Grubb KJ, Gada H, Fraser D, et al. Global results from the Optimize PRO Study: Standardized TAVR technique and care pathway. J Soc Cardiovasc Angiogr Interv. 2025;4(5):103515. doi:10.1016/j.jscai.2025.103515.
Yakubov S. Final Global Results from the Optimize PRO Study. Presented at: TCT 2025; October 25–28, 2025; San Francisco, CA.
Yakubov S. Impact of bioprosthetic valve performance on 5-year clinical outcomes after self-expanding TAVI or surgery in patients at intermediate or greater surgical risk. Presented at: NY Valves; June 2024; New York, NY.
Généreux P, Piazza N, Alu MC, et al. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J. 2021;42(19):1825–1857. doi:10.1016/j.jacc.2021.02.038.
Capodanno D, Petronio AS, Prendergast B, et al. Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2017;38(45):3382–3390. doi: 10.1093/eurheartj/ehx303.
Adapted from VARC-3 Writing Committee, Capodanno D, Petronio AS, et al. Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2017;38(45):3382–3390. doi:10.1093/eurheartj/ehx303.
Van Mieghem NM, Deeb GM, Søndergaard L, et al. Self-expanding transcatheter vs surgical aortic valve replacement in intermediate-risk patients: 5-year outcomes of the SURTAVI Randomized Clinical Trial. JAMA Cardiol. 2022;7(10):1000–1008. doi:10.1001/jamacardio.2022.2695.
