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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

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


Addressing a serious unmet need

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


Sobering perspective

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.


The partner trial protocol

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.


Edwards sapien thv delivered qol benefits

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.


Edwards sapien thv delivered 20 reduction in mortality

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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