Transcatheter aortic valve implantation (TAVi)
Medtronic key studies
Stay up to date on the latest clinical evidence from Medtronic. Key summaries demonstrate the efficacy of the CoreValve™/Evolut™ TAVI platform.
Download the Medtronic clinical trial overview brochure.
SMART Trial 1-year results
The SMall Annuli Randomized To Evolut or SAPIEN Trial, or SMART Trial, is a prospective, multi-center, international, randomized controlled trial comparing the Medtronic self-expandable (SE) Evolut™ system versus Edwards Lifesciences balloon-expandable (BE) SAPIEN™* transcatheter aortic valve implantation (TAVI) 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.
Evolut™ TAVI 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)† at 1 year vs. SAPIEN™* platform.‡ p < 0.001
Evolut™ TAVI: 9.4%
SAPIEN™* TAVI: 41.6%
Sample size
N = 716 total
N = 355 Evolut™ TAVI
N= 361 SAPIEN™* TAVI
Devices
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%
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)
† Valve performance as defined as freedom from BVD at 12 months. BVD is a composite including any of the following: hemodynamic structural valve dysfunction (mean gradient ≥ 20 mmHg), non-structural valve dysfunction (severe PPM or ≥ moderate aortic regurgitation), 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%).
TAVI 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.
Procedure and performance
Discover our procedural guidance and outcomes you can expect from the Evolut platform.
1. Herrmann HC, Mehran R, Blackman DJ, et al. Self-expanding or balloon-expandable TAVR in patients with a small aortic Annulus. N Engl J Med. Published online April 7, 2024. doi: 10.1056/NEJMoa2312573.
2. Reardon M, et al. Transcatheter versus surgical aortic valve replacement in aortic stenosis patients at low surgical risk: 4-year outcomes from the Evolut low risk trial. Presented at TCT; 2023.
3. Yakubov S, et al. Five-year incidence of bioprosthetic valve dysfunction in patients randomized to surgery or TAVR: insights from the CoreValve US Pivotal and SURTAVI Trials. Presented at CRT; 2023.
4. Grubb K. Impact of a standardized TAVI technique and care pathway in the Optimize PRO study. Presented at EuroPCR 2022; 2022; Paris, France.
5. 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.
6. 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.
7. 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.
8. Adapted from VARC-3 Writing Committee, et al. and Capodanno D, et al.
9. Strange G, Stewart S, Celermajer D, et al. Poor Long-Term Survival in Patients With Moderate Aortic Stenosis. J Am Coll Cardiol. October 15, 2019;74(15);1851-1863
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