Medtronic Plc. · NYSE:MDT
Medtronic — TCT 2023 Conference
36 slides from Medtronic's conference presentation, Oct 24, 2023
Slide 1: Four-year outcomes from the Evolut Low Risk Trial
Four-year outcomes from the Evolut Low Risk Trial Michael J. Reardon, M.D. Methodist DeBakey Heart and Vascular Center, Houston, TX On behalf of the Evolut Low Risk Trial Investigators October 2023
Slide 2: Study Administration
EVOLUT LOW RISK TRIAL | 4 YEAR RESULTS 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 M
Slide 3: Increasing Number of TAVR Procedures in Younger Lower Risk Patients
EVOLUT LOW RISK TRIAL | 4 YEAR RESULTS Background Increasing Number of TAVR Procedures in Younger Lower Risk Patients Trends in transcatheter and surgical aortic valve replacement (TAVR and SAVR) in the U.S. show yearly increases in the overall number of TAVR procedures and significant growth in TAV
Slide 4: NOTION 10-Year: Less SVD with CoreValve TAVR vs SAVR
EVOLUT LOW RISK TRIAL | 4 YEAR RESULTS Background NOTION 10-Year: Less SVD with CoreValve TAVR vs SAVR Long-term data are limited in “all comer” lower risk patients. In the NOTION 10-year, 37% of patients survived 10 years – the rates of valve degeneration, as assessed by various measures of structu
Slide 5: SVD Is Associated with Worse Clinical Outcomes
EVOLUT LOW RISK TRIAL | 4 YEAR RESULTS Background SVD Is Associated with Worse Clinical Outcomes • Our prior randomized studies of high- and intermediate-risk patients have demonstrated lower rates of SVD in patients undergoing CoreValve TAVR compared with surgery at 5 years1 • SVD was associated wi
Slide 6: Valve Performance Is Associated with Clinical Outcomes
EVOLUT LOW RISK TRIAL | 4 YEAR RESULTS Background Valve Performance Is Associated with Clinical Outcomes • Our prior randomized studies of high and intermediate risk patients have demonstrated superior valve performance, as determined by lower rates of bioprosthetic valve dysfunction, in patients un
Slide 7: Need For Close Follow-up of the Low Risk Population
EVOLUT LOW RISK TRIAL | 4 YEAR RESULTS Background Need For Close Follow-up of the Low Risk Population Reporting results more frequently in the low risk population will help establish the relationship between valve performance and clinical outcomes and to inform the heart teams on treatment options.
Slide 8: Objective
EVOLUT LOW RISK TRIAL | 4 YEAR RESULTS Objective To evaluate 4-year clinical and hemodynamic outcomes with TAVR vs SAVR in patients from the Evolut Low Risk trial 8 Reardon et al. Four-year outcomes from the Evolut Low Risk Trial | October 24, 2023 | TCT 2023 Conference
Slide 9: US Study Sites (N = 61)
EVOLUT LOW RISK TRIAL | 4 YEAR RESULTS US Study Sites (N = 61) Spectrum Health Univ. of Swedish MC Pittsburgh University St. John Sanford MC of Hospital Oregon Health & Michigan Strong Science University Memorial University Vermont Case MC MCMass General Abbott NW Baystate MC Beth Israel Deaconess Y
Slide 10: International Sites
EVOLUT LOW RISK TRIAL | 4 YEAR RESULTS International Sites Canada, Europe, Japan, Australia, New Zealand (N = 25) CHRU de Lille Jacques Cartier Erasmus St. Antonius Hospital Catherina Sapporo Higashi IUCPQ Clinique Pasteur Hospital Taoushukai Hospital McGill University and Montreal Heart Institute S
Slide 11: Study Design
EVOLUT LOW RISK TRIAL | 4 YEAR RESULTS Study Design Patients with Severe AS Low risk of death (<3%) from surgery Clinical Events Committee Patients Anatomy suitable withand for both TAVR Severe SAVR AS Echo Core Laboratory Low risk of death (<3%) from surgery Anatomy suitable Screening for both TAVR
Slide 12: Baseline Characteristics
EVOLUT LOW RISK TRIAL | 4 YEAR RESULTS Baseline Characteristics No Significant Difference Between Treatment Groups Evolut TAVR SAVR Demographic (N = 730) (N = 684) Age, years 74.1 ± 5.8 73.7 ± 5.9 < 70 years, % 21.4 24.0 Female, % 36.4 34.1 STS-PROM 2.0 ± 0.7 1.9 ± 0.7 NYHA class III/IV, % 24.9 28.2
Slide 13: Bioprosthetic Valve Performance at 4 Years
EVOLUT LOW RISK TRIAL | 4 YEAR RESULTS Bioprosthetic Valve performance at 4 Years Significantly Less Mean Gradient ≥ 20 mmHg and Severe PPM With Evolut vs Surgery Parameter Evolut TAVR SAVR P Value Mean gradient ≥ 20 mm Hga 4.0 (20/497) 8.9 (39/438) 0.002 Severe PVRa, % 0.0 (0/496) 0.0 (0/426) N/A S
Slide 14: Primary Endpoint: All-Cause Mortality and Disabling Stroke
EVOLUT LOW RISK TRIAL | 4 YEAR RESULTS Primary Endpoint: All-Cause Mortality and Disabling Stroke 26% Relative Reduction in Hazard for Death or Disabling Stroke (p = 0.05) with Evolut TAVR vs SAVR and the Curves Continue to Separate Over Time 25% HR = 0.74 (95% CI 0.54-1.00) 4 Years All-Cause Mortal
Slide 15: All-Cause Mortality and Disabling Stroke
EVOLUT LOW RISK TRIAL | 4 YEAR RESULTS All-Cause Mortality and Disabling Stroke Observed Differences in the Primary Endpoint Driven by Death All-Cause Mortality Disabling Stroke 20% HR 0.74 (95% CI 0.53-1.03) 20% HR 0.74 (95% CI 0.41-1.34) Log-rank p = 0.07 Log-rank p = 0.32 15% Evolut TAVR 15% Evol
Slide 16: All-Cause Mortality, Disabling Stroke or AV Rehospitalization
EVOLUT LOW RISK TRIAL | 4 YEAR RESULTS All-Cause Mortality, Disabling Stroke or AV Rehospitalization Significantly Lower Rate with Evolut TAVR vs SAVR HR 0.78 (95% CI 0.61-0.98) 4 Years 30% Log-rank p = 0.04 Δ -4.4% Evolut TAVR 3 Years AV Rehospitalization1 22.4% Disabling Stroke, or All-Cause Morta
Slide 17: Secondary Endpoints at 4 Years
EVOLUT LOW RISK TRIAL | 4 YEAR RESULTS Secondary Endpoints at 4 Years Secondary Endpoint Evolut TAVR SAVR P Value All-cause mortality, % 9.0 (64) 12.1 (76) 0.07 Cardiovascular mortality, % 5.3 (37) 7.3 (46) 0.12 Disabling stroke, % 2.9 (20) 3.8 (24) 0.32 AV hospitalizationa, % 10.3 (71) 12.1 (75) 0.
Slide 18: Paravalvular Regurgitation
EVOLUT LOW RISK TRIAL | 4 YEAR RESULTS Paravalvular regurgitation No Difference Between Groups in Moderate or Greater PVR Patients with PVR data at 4Y Patients with PVR data at all visits (paired data) Overall, p < 0.001 Overall, p < 0.001 ≥ Moderate, p = 0.50 ≥ Moderate, p = 0.52 100 0.4 1.6 100 1.
Slide 19: Comparative Hemodynamics
EVOLUT LOW RISK TRIAL | 4 YEAR RESULTS Comparative Hemodynamics Significantly Better Hemodynamics with Evolut TAVR vs SAVR 2.5 44.8 50.0 2.2 2.2 2.2 2.2 2.1 Effective Orifice Area, cm2 44.2 Mean Gradient, mm Hg 2.0 40.0 2.1 2.0 2.0 2.0 2.0 1.5 30.0 Evolut TAVR TAVR vs SAVR 1.0 SAVR p < 0.001, all ti
Slide 20: KCCQ Overall Summary Score
EVOLUT LOW RISK TRIAL | 4 YEAR RESULTS KCCQ Overall Summary Score Sustained Improvement from Baseline in QoL Through 4 Years 100 KCCQ Overall Summary Score 95 90.6 90.1 89.7 90 88.6 88.7 90.5 90.4 90.1 85 88.3 80 75 78.7 69.4 70 Evolut TAVR 68.6 65 SAVR 60 Baseline 1 Month 1 Year 2 Years 3 Years 4 Y
Slide 21: NYHA Classification by Visit
EVOLUT LOW RISK TRIAL | 4 YEAR RESULTS NYHA Classification by Visit Sustained Improvement in Functional Status at 4 Years p = 0.03 100 0.1 0.4 0.4 1.1 0.3 1.5 1.7 2.3 1.5 2.4 0.2 0.2 2.3 3.0 24.8 15.9 16.2 14.9 14.2 17.4 17.6 27.8 21.0 21.7 80 Patients, % 60 40 64.7 62.6 82.5 82.0 83.4 83.5 81.1 79.
Slide 22: Considerations
EVOLUT LOW RISK TRIAL | 4 YEAR RESULTS Considerations The Evolut Low Risk Trial has several important considerations • Patients enrolled in the Evolut Low Risk study were on the higher end of the spectrum of “low risk” patients owing to the minimal number of exclusions by the Screening Committee • P
Slide 23: Summary
EVOLUT LOW RISK TRIAL | 4 YEAR RESULTS Summary TAVR patients in the Evolut Low Risk trial continue to show durable outcomes for the primary endpoint and significantly better hemodynamics than SAVR through 4 years 26% relative Significantly 85% of Evolut Indicators of valve performance, reduction in
Slide 24: Clinical Implications
EVOLUT LOW RISK TRIAL | 4 YEAR RESULTS Clinical Implications Evolut has reported lower rates of death or disabling stroke versus state- of-the-art surgery that are diverging each year to 4 years1 In low risk patients, the Evolut platform is Evolut shows better hemodynamics over SAVR at all time poin
Slide 25: 4 Year Results in JACC
EVOLUT LOW RISK TRIAL | 4 YEAR RESULTS 4 Year Results in JACC Primary Endpoint: All-Cause Mortality or Disabling Stroke 25 Reardon et al. Four-year outcomes from the Evolut Low Risk Trial | October 24, 2023 | TCT 2023 Conference Reproduced with Permission from Forrest JK, et al. J Am Coll Cardiol. 2
Slide 26: Back Up
Back Up
Slide 27: Surgical Curves from SAVR Studies vs Age-Matched SS Actuarial Rates
SURGICAL CURVES FROM SAVR STUDIES VS AGE-MATCHED SS ACTUARIAL RATES 27 Reardon et al. Four-year outcomes from the Evolut Low Risk Trial | October 24, 2023 | TCT 2023 Conference 1. Thourani VH. SAVR Survival. AnnThorac Surg 2023. 2. Forrest JK. 4y Low Risk. JACC 2023. 3. Actuarial life table (https:/
Slide 28: Patient Flow
EVOLUT LOW RISK TRIAL | 4 YEAR RESULTS Patient Flow As Treated Cohort N = 1414 Attempted TAVR Attempted Surgery N = 730 N = 684 5 withdrew 30 withdrew 1 lost to follow-up 2 lost to follow-up 1-Year follow-up 1-Year follow-up N = 724 N = 652 7 withdrew 12 withdrew 2 lost to follow-up 6 lost to follow
Slide 29: Comparisons of the Evolut LR and PARTNER III studies
EVOLUT LOW RISK TRIAL | 4 YEAR RESULTS Comparisons of the Evolut LR and PARTNER III studies Medtronic Evolut PARTNER 3 Low Risk Trial1 Low Risk Trial2 Evolut R, Evolut PRO, or SAVR SAPIEN 3 SAVR CoreValve 31 mm 1478 patients randomized; 1000 patients randomized; 1:1 randomization 1:1 randomization E
Slide 30: Comparisons Of Surgical Valves and Sizing
EVOLUT LOW RISK TRIAL | 4 YEAR RESULTS Comparisons Of Surgical Valves and Sizing Evolut Low Risk Surgical Valves1 PARTNER 3 Surgical Valves2 Mean STS Score 30-day Mortality O/E Ratio Mean STS Score 30-day Mortality O/E Ratio 1.9% 1.2 0.63 1.9% 1.1 0.58 80% 80% 72.2% 60% 56.9% 60% Sutureless, n=89 40
Slide 31: Comparison of 1-Year Surgical Outcomes
EVOLUT LOW RISK TRIAL | 4 YEAR RESULTS Comparison of 1-Year Surgical Outcomes 1-Year Echo Evolut Low Risk Surgical Arm1 PARTNER 3 Surgical Arm2 EOA 2.0 cm2 1.8 cm2 11.6 mm Hg Surgical Arm Mean gradient 11.2 mm Hg None/trace 93.8% 90.9% total aortic regurgitation Mild total AR 7.6% 5.7% Moderate tota
Slide 32: Definitions of SVD from O'Hair et al JAMA Cardiol
EVOLUT LOW RISK TRIAL Definitions of SVD from O’Hair et al JAMA Cardiol Primary endpoint – moderate or greater hemodynamic SVD: Moderate SVD was defined as (1) hemodynamic valve deterioration (HVD) showing an increase in mean aortic gradient of 10 mm Hg or greater from discharge or 30-day echocardio
Slide 33: Thank You to Our Top Implanting Clinical Sites and Investigators
EVOLUT LOW RISK TRIAL Thank You to Our Top Implanting Clinical Sites and Investigators Interventional Clinical Site Surgeon Cardiologist Abbott Northwestern Hospital – Minneapolis Heart Institute, Judah Askew, Robert Saeid Farivar* Paul Sorajja Minnesota Abrazo Arizona Heart Hospital, Phoenix, Arizo
Slide 34: Thank You to Our Top Implanting Clinical Sites and Investigators
EVOLUT LOW RISK TRIAL Thank You to Our Top Implanting Clinical Sites and Investigators Clinical Site Surgeon Interventional Cardiologist Piedmont Heart Institute, Atlanta, Georgia James Kauten* Vivek Rajagopal Saint Francis Hospital, Roslyn, New York Newell Robinson George Petrossian Saint Joseph's
Slide 35: Indications and safety information for Evolut systems
The Medtronic CoreValve™ Evolut™ R, Evolut™ PRO+, and Evolut™ FX Systems are indicated for relief of aortic stenosis in Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Avoid prolonged or repeated exposure patients with symptomatic heart disease due to
Slide 36: medtronic.com
710 Medtronic Parkway LifeLine Minneapolis, MN 55432-5604 CardioVascular Technical Support USA Toll-free: 877.526.7890 Tel: +1.763.526.7890 Toll-free: 800.328.2518 rs.structuralheart@medtronic.com Tel: +1.763.514.4000 UC202406101a EN medtronic.com 10/2023