Slide 1: Evolut Low Risk Trial 5-Year Outcomes
5-Year Outcomes After Transcatheter or Surgical Aortic Valve Evolut Replacement in Low-Risk Patients Low Risk With Aortic Stenosis Trial Michael J. Reardon, MD1 and John K. Forrest, MD2 On behalf of the Evolut Low Risk Trial Investigators 1Methodist DeBakey Heart and Vascular Center, Houston, TX 2Ya
Slide 2: Disclosure of Relevant Financial Relationships
Disclosure of Relevant Financial Relationships • Within the prior 24 months, I have had a relevant financial relationship with a company producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients: Nature of Financial Relationship Ineligible Company Grant/Re
Slide 3: Study Administration
Study Administration Principal Investigators Executive Committee Michael Reardon, MD John Forrest, MD Michael Reardon, MD John Forrest, MD G. Michael Deeb, MD Steven Yakubov, MD Methodist DeBakey Yale University Methodist DeBakey Yale University University of Michigan OhioHealth Riverside Heart and
Slide 4: Background
Background • Transcatheter aortic valve replacement (TAVR) has emerged as the leading procedure for treating symptomatic severe aortic stenosis in the United States, irrespective of the patient's surgical risk • The Evolut Low Risk Trial (NCT02701283) is a multinational, prospective, randomized, int
Slide 5: Objective
Objective To evaluate 5-year outcomes with Evolut vs surgery in patients from the Evolut Low Risk trial
Slide 6: Evolut Low Risk Trial design
Evolut Low Risk Trial design Prospective, randomized interventional trial conducted at 86 international sites Severe trileaflet aortic stenosis Key eligibility Low predicted risk of death (<3%) from surgery by heart team assessment Anatomy suitable for both TAVR and surgery 1:1 Randomization May 201
Slide 7: Evolution of Evolut Transcatheter Aortic Valves
Evolution of Evolut Transcatheter Aortic Valves Evolut Low Risk Trial Valves Subsequent Generations 3.6% 73.0% 23.4% CoreValve Evolut R Evolut PRO Evolut PRO+ Evolut FX Evolut FX+ 2014 2015 2017 2019 2022 2024 First self-expanding •Recapturability Reduction in •Lower delivery profile •Greater precis
Slide 8: US Study Sites (N = 61)
US Study Sites (N = 61) Univ. of Michigan Univ. of Swedish MC Pittsburgh Spectrum Health St. John Hospital Strong Oregon Health & Science Univ. Memorial Sanford MC Case Univ. Vermont MC MC Mass General Baystate MC Beth Israel Deaconess Abbott NW Yale New Haven Hospital St. Joseph’s North Shore Univ.
Slide 9: International Study Sites (N = 25)
International: Canada, Europe, Japan, Australia, New Zealand (N = 25) CHRU de Lille Jacques Cartier St. Antonius Hospital Erasmus Catherina Hospital Sapporo Higashi Clinique Pasteur Tokushukai Hospital IUCPQ McGill University & Montreal Heart Institute Sendai Kousei Hospital Toronto General Hospital
Slide 10: Patient Flow
Patient Flow *Evolut R: 73%; Evolut Pro: 23.4%; CoreValve: 3.6%. †Edwards: 56.7%; Abbott: 18.6%; LivaNova: 13.8%; Medtronic: 10.9%.
Slide 11: Baseline Characteristics
Baseline Characteristics Evolut (N=730) Surgery (N=684) Age – yr 74.1 ± 5.8 73.7 ± 5.9 Age <70 yr 21.4% 24.0% Age <65 yr 5.8% 7.0% Female sex 36.4% 34.1% STS-PROM score 2.0% ± 0.7 1.9% ± 0.7 NYHA functional class III 24.8% 27.8% IV 0.1% 0.4% Hypertension 84.8% 82.6% Chronic lung disease, COPD 15.1%
Slide 12: All-Cause Mortality or Disabling Stroke
Primary Endpoint: All-cause Mortality Or Disabling Stroke 16.4% All-Cause Mortality or Log-rank p-value at 5Y = 0.47 Disabling Stroke 13.9% 15.5% 10.3% 10.7% 6.3% 7.4% 4.3% Months Since Procedure Evolut 730 715 706 685 651 615 542 Surgery 684 648 627 595 558 520 475
Slide 13: All-Cause Mortality and Disabling Stroke
All-Cause Mortality And Disabling Stroke Disabling Stroke All-Cause Mortality Log-rank p-value at 5Y = 0.57 Log-rank p-value at 5Y = 0.39 14.9% Patients Patients 13.5% 4.0% 3.6% Evolut 730 715 706 685 651 615 542 Evolut 730 718 709 691 659 626 555 Surgery 684 648 627 595 558 520 475 Surgery 684 656
Slide 14: Non-Cardiovascular and Cardiovascular Mortality
Non-Cardiovascular And Cardiovascular Mortality Non-Cardiovascular Mortality Cardiovascular Mortality Log-rank p-value at 5Y = 0.73 Log-rank p-value at 5Y = 0.15 Patients 5 Years Patients Δ 2.1% 9.3% 2 Years 6.8% Δ 1.1% 7.2% 6.2% Months Since Procedure Months Since Procedure Evolut 730 718 709 691 6
Slide 15: 5-Year Clinical Outcomes
5-Year Clinical Outcomes Evolut Surgery HR (95% CI) P Value (log-rank) All-cause mortality or disabling stroke 15.5% 16.4% 0.90 (0.69, 1.18) 0.47 All-cause mortality 13.5% 14.9% 0.88 (0.66, 1.17) 0.39 Cardiovascular death 7.2% 9.3% 0.75 (0.51, 1.11) 0.15 Non-cardiovascular death 6.8% 6.2% 1.08 (0.70
Slide 16: Reinterventions
Reinterventions No difference in reinterventions between Evolut and surgery Evolut Surgery P Value (log-rank) Reintervention 21 (3.3%) 14 (2.5%) 0.44 Surgical 18 (2.8%) 11 (2.0%) 0.34 Transcatheter 3 (0.5%) 3 (0.5%) 0.84 Reinterventions in Evolut arm (N=21) Reinterventions in surgery arm (N=14) 2 de
Slide 17: All-Cause Mortality Or Disabling Stroke Subgroup Analysis
All-Cause Mortality Or Disabling Stroke Subgroup Analysis Evolut Surgery Variable HR (95% CI) P Value KM rate, 5 years Age, years 0.8451 <75 11.9% 13.4% 0.87 (0.57-1.33) ≥75 18.9% 19.8% 0.91 (0.64-1.29) Sex 0.5366 Female 12.9% 12.1% 1.05 (0.63-1.76) Male 17.0% 18.6% 0.86 (0.63-1.18) STS-PROM, % 0.82
Slide 18: Hemodynamic Valve Performance
Hemodynamic Valve Performance EOA and MG P<0.001 at 5 Years Time Post Procedure Evolut EOA 637 577 565 535 495 439 399 Surgery EOA 596 406 525 435 397 370 313 Evolut MG 717 704 662 607 549 498 467 Surgery MG 679 632 597 515 457 436 387
Slide 19: Paravalvular Regurgitation
Paravalvular Regurgitation
Slide 20: Effect of 1-Month Paravalvular Regurgitation on Mortality in Evolut
Effect of 1-Month Paravalvular Regurgitation on Mortality in Evolut Early mild paravalvular regurgitation had no impact on 5-year mortality KM Rate at 5 Years 95% CI None/trace PVR at 1 month 13.0% 10.1%–16.7% Mild PVR at 1 month 14.1% 10.1%–19.5% Log-rank p-value = 0.67 PVR at 1 Month None/trace 43
Slide 21: KCCQ Overall Summary Score
KCCQ Overall Summary Score Alive and well at 5 Years (alive and KCCQ summary score >75) Patients, % Change from Baseline n 720 689 661 617 561 520 Evolut Mean ± SD 20.0 ± 21.1 21.6 ± 20.6 20.9 ± 20.8 20.1 ± 20.6 19.3 ± 20.7 18.9 ± 21.9 n 645 607 565 522 483 445 Surgery Mean ± SD 9.2 ± 22.3 20.7 ± 20
Slide 22: NYHA Classification By Visit
NYHA Classification By Visit Both Evolut and surgery gave patients good relief from symptoms Patients, %
Slide 23: Summary
Summary Low surgical risk patients with severe aortic stenosis who were treated with either Evolut or surgery showed comparable rates of all-cause mortality or disabling stroke at 5 years (15.5% Evolut and 16.4% surgery, p=0.47) • Importantly, cardiovascular mortality remains similar for Evolut and
Slide 24: Simultaneously published in JACC
Simultaneously published in JACC
Slide 25: Indications and Safety Information
Indications Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Avoid prolonged or repeated exposure to The Medtronic Evolut PRO+, Evolut FX, and Evolut FX+ Systems are indicated for relief of aortic stenosis in patients with the vapors. Damage may result
Slide 26: Medtronic contact details
710 Medtronic Parkway LifeLine ©2025 Medtronic. All rights reserved. Medtronic, Medtronic logo, Minneapolis, MN 55432-5604 CardioVascular Technical Support and Engineering the extraordinary are trademarks of Medtronic. All USA Toll-free: 877.526.7890 other brands are trademarks of a Medtronic compan