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.
Evolut™ Low Risk Trial1
Evolut™ TAVR shows durable clinical outcomes in low-risk patients at five years.1
5-year all-cause mortality or disabling stroke in Evolut™ Low Risk Trial
N = 730 TAVR, N = 684 SAVR
Evolut™ R 73%/Evolut™ PRO 23.4%/CoreValve™ 3.6%
TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker.
SMART Trial 2-year results2
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.
Through 2 years, Evolut™ TAVR continued to show superior valve performance† in small annulus patients‡ compared to SAPIEN™* TAVR with sustained excellent patient outcomes.2
Bioprosthetic valve dysfunction (BVD) through 2 years
Difference, -35.9% (95% CI -43.0%, -28.7%)
p < 0.001
Clinical outcome composite
All-cause mortality, disabling stroke, or heart failure rehospitalization through 2 years
HR 1.01 (95% CI 0.71, 1.43) p = 0.97
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%
† Valve performance as defined as freedom from BVD through 24 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.
Impact of a standardized TAVR technique and care pathway in the Optimize PRO study3
The cusp overlap technique, with an optimized care pathway, demonstrated excellent clinical outcomes in this analysis with consistently low pacemaker rates (11.1% PPI at 30 days overall, 6.4% PPI with 4-step cusp overlap technique adherence/compliance) and low rates of PVL (0% moderate/severe at discharge).
Paravalvular leak (PVL) at discharge
n = 618
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 BVD4
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 out of 5 years
N = 2295
CoreValve™ 89%/Evolut™ R 11%
§ BVD was defined as5,6: SVD7 (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 5-year Trial8
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
N = 864 TAVR, N = 796 SAVR
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.
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 Confida™ Brecker guidewire is specifically designed for transcatheter aortic valve replacement (TAVR) procedures.
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.
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