Medtronic Plc. · NYSE:MDT
Medtronic — EuroPCR 2021
13 slides from Medtronic's conference presentation, Jun 12, 2021
Slide 1: The Evolut Low Risk Trial Complete 2-Year Follow-Up
THE EVOLUT LOW RISK TRIAL COMPLETE 2-YEAR FOLLOW-UP JOHN K. FORREST, MD, YALE UNIVERSITY SCHOOL OF MEDICINE, NEW HAVEN, CT, USA FOR THE EVOLUT LOW RISK TRIAL INVESTIGATORS Presented by J.K. Forrest on behalf of the Evolut Low Risk investigators at EuroPCR 2021
Slide 2: Disclosures
DISCLOSURES Edwards Lifesciences: Grant Support, Advisory Board, and Proctoring. Medtronic Inc: Grant Support, Advisory Board, and Proctoring.
Slide 3: Evolut Low Risk Trial: Methods
EVOLUT LOW RISK TRIAL: METHODS • The Evolut Low Risk Trial enrolled patients with severe aortic stenosis who had a 30-day surgical mortality risk of <3% per local heart team assessment, confirmed by a national screening committee. • The primary analysis cohort comprised patients who underwent an att
Slide 4: Patient Follow-Up at 2-Years
PATIENT FOLLOW-UP AT 2-YEARS As-Treated Cohort N=1414 Attempted TAVR Attempted surgery N=730 N=684 5 Withdrew 29 Withdrew 1 lost to follow-up 2 lost to follow-up Completed 1-year follow-up† Complete 1-year follow-up† N= 724/730 (99.2%) N=653/684 (95.5%) 7 Withdrew 12 Withdrew 2 lost to follow-up 6 l
Slide 5: Primary Outcome: All-Cause Mortality or Disabling Stroke
PRIMARY OUTCOME All-Cause Mortality or Disabling Stroke ALL CAUSE MORTALITY OR DISABLING STROKE 20% TAVR Surgery 15% TAVR: 2.5% TAVR: 4.3% 10% Surgery: 4.3% Surgery: 6.3% Log-rank p = 0.057 Log-rank p = 0.084 5% 0% 0 6 12 18 24 Time Since Procedure (Months) No. at risk TAVR 730 725 715 706 691 674 S
Slide 6: All-Cause Mortality and Disabling Stroke
ALL-CAUSE MORTALITY AND DISABLING STROKE All-Cause Mortality Disabling Stoke
Slide 7: Landmark Analysis
LANDMARK ANALYSIS 10% All-cause mortality or disabling 8% 0 to 1 year 1 to 2 years TAVR Surgery Log-rank p TAVR Surgery Log-rank p 6% 2.5% 4.3% 0.057 1.9% 2.1% 0.742 stroke 4% 2% 0% 0 6 12 18 24 TAVI Surgery
Slide 8: 2-Year Bayesian Predicted Outcomes
2-YEAR BAYESIAN PREDICTED OUTCOMES Bayesian Rates TAVR Surgery Death or disabling stroke 5.3 6.7 All-cause mortality 4.5 4.5 Cardiovascular 2.8 3.5 AV reintervention 0.7 1.2 Valve thrombosis 0.6 0.5 Valve endocarditis 0.2 1.6 All stroke 4.9 5.3 Disabling 1.1 3.5 Non-disabling 3.9 2.2 Permanent pacem
Slide 9: 2-Year Bayesian Predicted and Actual Outcomes
2-YEAR BAYESIAN PREDICTED AND ACTUAL OUTCOMES Bayesian Rates KM Rates TAVR Surgery TAVR Surgery Death or disabling stroke 5.3 6.7 4.3 6.3 All-cause mortality 4.5 4.5 3.5 4.4 Cardiovascular 2.8 3.5 2.2 3.3 AV reintervention 0.7 1.2 0.8 0.8 Valve thrombosis 0.6 0.5 0.3 0.2 Valve endocarditis 0.2 1.6 0
Slide 10: Valve Hemodynamics to 2 Years
VALVE HEMODYNAMICS TO 2 YEARS Superior haemodynamics with TAVR vs surgery at each follow-up (all p < 0.001) 3.0 60.0 mean gradient, mm Hg Aortic-valve area, cm2 2.5 44.8 2.2 2.2 2.2 2.2 50.0 Aortic-valve 2.0 40.0 44.2 2.0 2.0 2.0 2.0 1.5 TAVR 30.0 1.0 0.9 Surgery 20.0 10.5 11.2 11.3 11.7 0.5 0.8 10.
Slide 11: Paravalvular Leak
PARAVALVULAR LEAK p < 0.001 p < 0.001 0.1 0.7 0.4 100% 3.6 2.2 1.7 2.6 Proportion of patients 26.6 80% 33.1 60% 97.1 97.0 40% 63.1 71.7 20% 0% TAVR Surgery TAVR Surgery N=667 N=582 N=594 N=492 1 Year 2 Years None/Trace Mild Moderate Severe
Slide 12: Prosthesis-Patient Mismatch
PROSTHESIS-PATIENT MISMATCH Per VARC 31 p < 0.001 p < 0.001 100% 1.4 5.5 2.1 4.9 6.6 7.2 Proportion of patients 18.5 19.1 80% 60% 92.0 90.8 40% 76.0 76.0 20% 0% TAVR Surgery TAVR Surgery N=564 N=525 N=530 N=425 1 Year 2 Years None Moderate Severe 1Genereux P, et al. J Am Coll Cardiol 2021; in press.
Slide 13: Summary
SUMMARY 2-Year Results from the Evolut Low Risk Trial: • The KM rate of death or disabling stroke at 2 years was 4.3% with TAVR and 6.3% with surgery, p = 0.084. • Between 1 and 2 years there was no convergence of the KM curves for death or disabling stroke. • Surgery was superior to TAVR in regards