Stay up to date on the latest clinical evidence from Medtronic. Key summaries demonstrate the efficacy of the CoreValve™/Evolut™ TAVR platform.
Download the Medtronic clinical trial overview brochure.
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 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.
Evolut™ TAVR 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™ TAVR: 9.4%
SAPIEN™* TAVR: 41.6%
N = 716 total
N = 355 Evolut™ TAVR
N = 361 SAPIEN™* TAVR
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%).
TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker.
Evolut™ TAVR shows excellent outcomes in low-risk patients, with a 26% reduction in hazard for death or disabling stroke at 4 years.
N = 730 TAVR, N = 684 SAVR
Evolut™ R 73%/Evolut™ PRO 23.4%/CoreValve™ 3.6%
All-cause mortality or disabling stroke
TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker.
CoreValve™/Evolut™ TAVR had significantly better valve performance than surgery as assessed by bioprosthetic valve dysfunction (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).
N = 2,298
CoreValve™ 89%/Evolut™ R 11%
BVD out of 5 years
§ BVD was defined as4,5: SVD6 (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.
The cusp overlap technique, with an optimized care pathway, demonstrated excellent clinical outcomes in this interim analysis with single-digit pacemaker rates (9.8% PPI at 30 days), low rates of PVL (0% moderate/severe at discharge), and one-day median discharge from main cohort.
N = 400 patients in the main cohort. At the conclusion of the study, more than 650 patients will have been evaluated.
Evolut™ PRO+ 91.5%/Evolut™ PRO 8.0%
PVL (main cohort)
◊ One patient with mild-moderate PVL.
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.
N = 864 TAVR, N = 796 SAVR
CoreValve™ 84%/Evolut™ R 16%
Mean gradient and EOA over time implanted set
TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker.
Review recent data that reinforces the excellent outcomes seen in our Medtronic clinical trials.
Discover our procedural guidance and outcomes you can expect from the Evolut™ platform.
Medtronic Academy offers a wide range of resources for the Evolut™ TAVR platform.
The Evolut™ FX transcatheter aortic valve replacement (TAVR) system sets new expectations for precision, control, and predictability in TAVR procedures.
The Evolut™ FX+ transcatheter aortic valve system is designed with specific features intended to enable lifetime management solutions such as coronary access.
The Evolut™ PRO+ TAVR system features the lowest delivery profile for 23–29 mm valves and advanced sealing with an external tissue wrap on all valve sizes.
™* Third-party brands are trademarks of their respective owners.