Slide 1: Two-Year Outcomes of the Five-Year SMART Trial
Two-Year Outcomes of the Five-Year SMART Trial SMART Small Annuli Randomized to Evolut or SAPIEN Howard C. Herrmann, MD Roxana Mehran, MD Didier Tchétché, MD on behalf of the SMART Trial Investigators
Slide 2: Disclosure of relevant financial relationships
Disclosure of relevant financial relationships Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below: Financial Relationship Company Institutional grants/research support Abbott Vascular, Edwards LifeSciences,
Slide 3: Background
Background The SMART Trial: Prior Evidence: • Designed to compare performance for 2 most widely available • Hemodynamics of Evolut valve are superior to those of commercial transcatheter aortic valve replacement (TAVR) SAPIEN valve. devices in patients with severe aortic stenosis and a small aortic
Slide 4: SMART Trial Design
SMART Trial Design Prospective, randomized controlled, post-market trial conducted at 83 international sites All-comer trial with all surgical risk categories including bicuspid patients 716 Patients Treated Key eligibility • Symptomatic severe AS* (N=355) • Small aortic annulus (≤430 mm2 by MDCT) R
Slide 5: Baseline characteristics
Baseline characteristics Characteristic Evolut (N=355) SAPIEN (N=361) Age – yr 80.1 ± 6.3 80.3 ± 6.1 Female sex 87.9% 85.6% STS-PROM score – % 3.3 ± 1.9 3.2 ± 1.7 NYHA functional class III/IV 43.4% 39.9% Diabetes 29.3% 34.3% Hypertension 82.5% 86.7% COPD or chronic lung disease 18.0% 17.6% Cerebrova
Slide 6: Valve sizing
Valve sizing Evolut SAPIEN Aortic annulus size (N=355) (N=361) SAPIEN (N=361) Mean area (mm2) 380.9 ± 34.2 382.8 ± 33.9 Mean perimeter (mm) 70.3 ± 3.2 70.4 ± 3.2 Chosen size based on IFU Evolut SAPIEN Device Sizing (N=350) (N=365) Smaller than 14 (4.0%) 6 (1.6%) recommended Recommended 309 (88.3%) 3
Slide 7: SMART Trial results at 1 year: Co-primary outcomes
SMART Trial results at 1 year: Co-primary outcomes
Slide 8: SMART Trial results at 1 year: Hemodynamics
SMART Trial results at 1 year: Hemodynamics
Slide 9: Use of SAPIEN valve was a predictor of BVD
Use of SAPIEN valve was a predictor of BVD Finding consistent throughout entire range of annulus area in the trial Incidence of BVD Multivariable predictors of BVD SAPIEN through 1 Year Evolut Overall Cohort Odds Ratio P Value (Evolut + SAPIEN) (95% CI) SAPIEN (vs Evolut) 8.21 <0.001 (5.10-13.23) BS
Slide 10: Results at 2 Years
Results at 2 Years
Slide 11: Population and Follow-up Flowchart
Population and Follow-up Flowchart
Slide 12: Clinical outcome composite & components through 2 years
Clinical outcome composite & components through 2 years Mortality, Disabling Stroke, or HF Rehospitalization
Slide 13: Safety events
Safety events 1 Year 2 Years Evolut SAPIEN Log-Rank Evolut SAPIEN Log-Rank KM% (N=355) (N=361) P Value (N=355) (N=361) P Value All-cause mortality 5.1% 5.9% 0.676 12.7% 11.4% 0.657 Cardiovascular mortality 3.4% 3.7% 0.882 7.2% 6.4% 0.706 Heart failure rehospitalization 4.1% 3.5% 0.661 6.1% 6.0% 0.95
Slide 14: Prosthetic Valve Thrombosis Through 2 Years (CEC adjudicated)
Prosthetic Valve Thrombosis Through 2 Years (CEC adjudicated)
Slide 15: Bioprosthetic valve dysfunction through 2 years
Bioprosthetic valve dysfunction through 2 years Difference, -35.9% (95% CI -43.0%, -28.7%) p<0.001 60 50 48.4% Percentage of patients 40 30 20 12.5% 10 0 Evolut 1 SAPIEN HSVD = Mean gradient ≥ 20 mmHg NSVD = Severe PPM through 1 year per VARC-3 or ≥moderate total AR
Slide 16: SMART Trial results at 2 years: Hemodynamics
SMART Trial results at 2 years: Hemodynamics Values based on independent Echocardiography Core Laboratory (Mayo) assessment.
Slide 17: Total Aortic Regurgitation
Total Aortic Regurgitation Discharge 30 Days 1 Year 2 Years 2Mild Total AR 13.3% 5.1% 17.2% 12.7% 14.1% 20.3% 16.7% 19.8% P value P<0.001 P=0.106 P=0.043 P=0.354 100 5 0 0 9 x2) < 80 + 2 a 5 60 + o ? a0 4 86.7 82.8 85.9 83.3 80.2 5 Oo @ 204 fal 0 Evolut SAPIEN Evolut SAPIEN Evolut SAPIEN Evolut SAPI
Slide 18: Alternative valve dysfunction definitions through 2 years
Alternative valve dysfunction definitions through 2 years Alternative definition Evolut SAPIEN Difference P Value Evolut Better SAPIEN Better (Cumulative rates through 2 years) (Superiority _—_— el Mean gradient 220 mmHg 4.7% : -37.7% <0.001 a Individual Mean gradient 222.5 mmHg! 2.6% . -29.9% <0.00
Slide 19: Adverse hemodynamics affect clinical outcomes
Adverse hemodynamics affect clinical outcomes Elevated mean gradient after surgical and transcatheter Severe prosthesis-patient mismatch after TAVR aortic valve replacement reduces survival increases mortality Australian National Echo Registry (6,050 patients with prior aortic valve replacement) Met
Slide 20: Summary
Summary • The randomized SMART trial compared the Evolut and SAPIEN TAVR valves in 716 patients (87% women) with a small aortic annulus. • After 2 years of follow up, we observed similar rates for the clinical outcome composite of death, disabling stroke, and HF hospitalization. • All individual and
Slide 21: Backup
Backup
Slide 22: Total Aortic Regurgitation (paired)
Total Aortic Regurgitation (paired) Values based on independent Echocardiography Core Laboratory (Mayo) assessment.
Slide 23: Quality of life
Quality of life KCCQ Overall Summary Score, Mean + SD 100 4 100% g 804 —< s 2 80% is 2 = 60 4 4 ° = 60% s [-) oO J o _ * B 40% 2 5 P 2 * 20 4 EF 20% —eEvolut -e-Sapien 0 0% Baseline 30 Days 1 Year 2 years Evolut 354 338 300 266 VARC-3 KCCQ ordinal outcome at 2 years Evolut vs SAPIEN, p=0.388 66.2% 6
Slide 24: Thank You to All of Our Patients, Trial Investigators, Committees
Trial Leadership/Committees: • Executive Committee Thank You to • Steering Committee • Case Planning Committee All of Our Patients, • Training & Education Committee • Publication Committee Trial Investigators, Independent Safety Committees: • Clinical Events Committee Research Coordinators, • Data S
Slide 25: Definitions
Definitions MG ≥20 (SMART HSVD): Based on SVD, defined as mean gradient ≥20 mmHg at any follow-up echo from discharge through the 2-year study visit MG ≥22.5 (Playford): Based on SVD, defined as mean gradient ≥22.5 mmHg at any follow-up echo from discharge through the 2-year study visit MG ≥25: Base
Slide 26: SMART Trial Clinical Sites
SMART Trial Clinical Sites • The Leeds Teaching Hospitals NHS, Leeds, UK • University of Florida, Gainesville, FL • Morristown Medical Center, Morristown, NJ • Allegheny General Hospital, Pittsburgh, PA • Toronto General Hospital, Toronto, Canada • Los Robles Hospital & Medical Center, Thousand Oaks
Slide 27: Indications
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 28: Medtronic contact details
710 Medtronic Parkway LifeLine ©2025 Medtronic. Medtronic, Medtronic logo, and Engineering the Minneapolis, MN 55432-5604 CardioVascular Technical Support extraordinary are trademarks of Medtronic. *Third-party brands USA Toll-free: 877.526.7890 are trademarks of their respective owners. All other b