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 three 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 three 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 3-year results
Evolut™ TAVR continues to demonstrate superior valve performance‡ compared to SAPIEN™* TAVR and strong patient outcomes with significantly lower rates of valve thrombosis.§
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
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, underreferral, 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.
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%.
TM* 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 of 716 patients, consisting of majority low surgical risk participants (52.1%).
‡ Valve performance as defined as freedom from bioprosthetic valve dysfunction (BVD) through 36 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), clinical thrombosis, endocarditis, and aortic valve reintervention.
§ Clinical valve thrombosis as defined by VARC-3.
◊ Reference echo (30-day if available, otherwise discharge echo). PPM as defined by VARC-3.
¶ Valve performance means the valve works better after TAVR, with improved blood flow. The SMART study defined valve performance 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 prosthesis patient mismatch or ≥ moderate aortic regurgitation), thrombosis, endocarditis, and aortic valve reintervention.
Herrmann H. Three-Year Outcomes of the SMART Trial. Presented at: EuroPCR; May 20, 2026; Paris, France.
Tchétché D, Mehran R, Blackman DJ, et al. Transcatheter aortic valve implantation by valve type in women with small annuli: Results from the SMART Randomized Clinical Trial. JAMA Cardiol. 2024;9(12):1106–1114. doi:10.1001/jamacardio.2024.3241.
Vogel B, Acevedo M, Appelman Y, et al. The Lancet women and cardiovascular disease commission: Reducing the global burden by 2030. Lancet. 2021;397(10292):2385–2438. doi:10.1016/S0140-6736(21)00684-X.
Confida™ Brecker guidewire
Evolut™ FX system
Evolut™ FX+ system