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Helping to Solve a Grave Problem

Helping to Solve a Grave Problem. Onset Severe Symptoms. Aortic stenosis is life threatening and progresses rapidly Survival after onset of symptoms is 50% at 2 years and 20% at 5 years 1 “Surgical intervention [for severe AS] should be performed promptly once even…minor symptoms occur” 1.

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Helping to Solve a Grave Problem

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  1. Helping to Solve a Grave Problem Onset Severe Symptoms • Aortic stenosis is life threatening and progresses rapidly • Survival after onset of symptoms is 50% at 2 years and 20% at 5 years1 • “Surgical intervention [for severe AS] should be performed promptly once even…minor symptoms occur”1 100 80 Angina Latent Period (Increasing Obstruction, Myocardial Overload) Syncope Failure 60 Survival, % 40 0 2 4 6 Average Survival, y 20 0 40 50 60 70 80 Age, y

  2. Addressing a Serious Unmet Need • At least 40% of patients with severe aortic stenosis (AS) do not have an AVR2-8 No AVR Aortic Valve Replacement (AVR) Patients, % 1999 2005 2006 2009 2009 2010 2006

  3. Sobering Perspective 5-Year Survival Survival, % * * * * * † * National Institutes of Health. National Cancer Institute. Surveillance Epidemiology and End Results. Cancer Stat Fact Sheets. http://seer.cancer.gov/statfacts/. Accessed November 16, 2010. † Using constant hazard ratio. Data on file, Edwards Lifesciences LLC. Analysis courtesy of Murat Tuczu.

  4. The PARTNER Trial Protocol Severe Symptomatic Native Aortic Valve Stenosis Yes No Assessment Operability 2 Cohorts Individually Powered (N = 1,057) Cohort A (n = 699) Cohort B (n = 358) Cohort A Yes Assessment Transfemoral Access No Yes Assessment Transfemoral Access No TF (n = 492) TA (n = 207) Not in Study 1:1 Randomization 1:1 Randomization 1:1 Randomization TF TAVR (n = 244) AVR (Control) (n = 248) TA TAVR (n = 104) AVR (Control) (n = 103) TF TAVR (n = 179) Standard Therapy (Control) (n = 179) vs vs vs Primary Endpoint: All-Cause Mortality OverLength of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority) Primary Endpoint: All-Cause Mortality (1 yr)(Non-inferiority) TA, transapical; TF, transfemoral.

  5. Edwards SAPIEN THV Delivered QOL Benefits 100 Standard Therapy 80 60 40 20 0 Edwards SAPIEN THV MCID = 5 points • Improvement in quality of life KCCQ Score (Mean) ∆ = 13.9P < .001 ∆ = 24.5P < .001 0 2 4 6 8 10 12 Months MCID, minimum clinically important difference.

  6. Edwards SAPIEN THV Delivered 20% Reduction in Mortality Edwards SAPIEN THV Standard Therapy • ∆ at 1 yr = 20.0%NNT = 5.0 pts 100 80 • 20% absolute reduction in mortality at 1 year 50.7% All-Cause Mortality, % 60 • HR [95% CI] =0.51 [0.38, 0.68] • P (log rank) < .0001 40 30.7% 20 Months 0

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