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Edwards Lifesciences Irvine, USA I Nyon, Switzerland I Tokyo, Japan I Singapore, Singapore I São Paulo, Brazil edwards.com
The Edwards SAPIEN transcatheter heart valve and delivery systems bearing the CE conformity marking comply with the requirements of the European Medical Device Directive 93/42/EEC. For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions, and adverse events.
Caution: not intended for uS distribution.
Edwards is a trademark of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, and PARTNER are trademarks of Edwards Lifesciences Corporation and registered in the United States Patent and Trademark Office.
© 2010 Edwards Lifesciences Corporation. All rights reserved. E1679/11-10/THV
References
1. Data on file, Edwards Lifesciences LLC. 2. Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363;1597-1607. 3. Spertus J, Peterson E, Conrad MW, et al. Monitoring clinical changes in patients with heart failure: a comparison of methods. Am Heart J. 2005;150:707-715. 4. National Institutes of Health. National Cancer Institute. Surveillance Epidemiology and End Results. Cancer Fact Sheets. http://seer.cancer.gov/statfacts/. Accessed November 16, 2010.
Establishing the New Standard of Care for Inoperable Aortic Stenosis
THE PARTNER TRIALCOHORT B RESULTS
E D W A R D S T R A N S C A T H E T E R H E A R T V A L V E P R O G R A M
• Superior survival
• Significantly improved cardiac function
• Dramatic reduction in symptoms
• Restored quality of life
A New Lifeline for Inoperable Aortic Stenosis Patients
T h e E d w a r d s S A P I E N T r a n s c a t h e t e r H e a r t V a l v e
T H E P A R T N E R T R I A L E S T A B L I S H I N G T H E N E w S T A N D A R D o f C A R E f o R I N o P E R A B L E A o R T I C S T E N o S I S
in all-cause mortality orhospitalization at 1 year(co-primary endpoint; P < .001)2
in cardiovascular mortalityat 1 year (P < .001)2
All
-Ca
use
Mo
rta
lity
, %
Months
100
80
60
40
20
00 6 12 18 24
P < .001∆ at 1 y = 20.0%NNT = 5.0 pts
Standard Therapy
Edwards THV
30.7%
50.7%
Co-PRImARy ENDPoINT: ALL-CAuSE moRTALITy1,2
absolute reduction29%
absolute reduction24%
Need to treat just 5 patients to save a life1
20%absolute reduction
in mortality 2
Despite expert care and frequent BAV (78.2%), standard therapy failed to alter the dismal
natural course of disease1
The Edwards SAPiEN THV Significantly improves Survival
NNT = 5
COHORT B POPULATiON PROfiLE1
Mean age 83 y
NYHA Class III-IV 93%
COPD, O2 dependent 23%
PVD 28%
Porcelain aorta 15%
Chest wall deformity 7%
CAD 71%
Frail 23%
Definitive Results Through Rigorous Design
The PARTNER (Placement of AoRtic TraNscathetER Valves) Trial represents a paradigm shift in clinical investigation and interpretability. As the world’s first prospective, randomized, and controlled trial for transcatheter heart valves, the PARTNER Trial sets new standards in site selection, case screening, study management, multidisciplinary teamwork, and patient follow-up.1
The PARTNER Trial consists of two individually powered patient cohorts.
• In Cohort A, the safety and effectiveness of the Edwards SAPIEN Transcatheter Heart Valve (THV) was compared to surgical aortic valve replacement (sAVR) in high-risk patients with severe aortic stenosis. The results of Cohort A are forthcoming.1
• In Cohort B, the safety and effectiveness of the Edwards SAPIEN THV was compared to best medical management (standard therapy) in inoperable patients with severe aortic stenosis. Patient selection required at least two cardiothoracic surgeons and an interventional cardiologist to agree that patients were not suitable candidates for surgery.1
CAD, coronary artery disease; COPD, chronic obstructive pulmonary disease; NYHA, New York Heart Association; PVD, peripheral vascular disease; BAV, balloon aortic valvotomy.
THE PARTNER TRIAL PRoToCoL1
No
Yes
Yes ASSESSMENTTransfemoral Access
Not in Study
TransfemoralStandardTherapyVS
Cohort Bn = 358
Cohort An = 700
ASSESSMENTOperability
No
1:1 Randomization
Symptomatic Severe Aortic Stenosis
T H E P A R T N E R T R I A L E S T A B L I S H I N G T H E N E w S T A N D A R D o f C A R E f o R I N o P E R A B L E A o R T I C S T E N o S I S
in all-cause mortality orhospitalization at 1 year(co-primary endpoint; P < .001)2
in cardiovascular mortalityat 1 year (P < .001)2
All
-Ca
use
Mo
rta
lity
, %
Months
100
80
60
40
20
00 6 12 18 24
P < .001∆ at 1 y = 20.0%NNT = 5.0 pts
Standard Therapy
Edwards THV
30.7%
50.7%
Co-PRImARy ENDPoINT: ALL-CAuSE moRTALITy1,2
absolute reduction29%
absolute reduction24%
Need to treat just 5 patients to save a life1
20%absolute reduction
in mortality 2
Despite expert care and frequent BAV (78.2%), standard therapy failed to alter the dismal
natural course of disease1
The Edwards SAPiEN THV Significantly improves Survival
NNT = 5
COHORT B POPULATiON PROfiLE1
Mean age 83 y
NYHA Class III-IV 93%
COPD, O2 dependent 23%
PVD 28%
Porcelain aorta 15%
Chest wall deformity 7%
CAD 71%
Frail 23%
Definitive Results Through Rigorous Design
The PARTNER (Placement of AoRtic TraNscathetER Valves) Trial represents a paradigm shift in clinical investigation and interpretability. As the world’s first prospective, randomized, and controlled trial for transcatheter heart valves, the PARTNER Trial sets new standards in site selection, case screening, study management, multidisciplinary teamwork, and patient follow-up.1
The PARTNER Trial consists of two individually powered patient cohorts.
• In Cohort A, the safety and effectiveness of the Edwards SAPIEN Transcatheter Heart Valve (THV) was compared to surgical aortic valve replacement (sAVR) in high-risk patients with severe aortic stenosis. The results of Cohort A are forthcoming.1
• In Cohort B, the safety and effectiveness of the Edwards SAPIEN THV was compared to best medical management (standard therapy) in inoperable patients with severe aortic stenosis. Patient selection required at least two cardiothoracic surgeons and an interventional cardiologist to agree that patients were not suitable candidates for surgery.1
CAD, coronary artery disease; COPD, chronic obstructive pulmonary disease; NYHA, New York Heart Association; PVD, peripheral vascular disease; BAV, balloon aortic valvotomy.
THE PARTNER TRIAL PRoToCoL1
No
Yes
Yes ASSESSMENTTransfemoral Access
Not in Study
TransfemoralStandardTherapyVS
Cohort Bn = 358
Cohort An = 700
ASSESSMENTOperability
No
1:1 Randomization
Symptomatic Severe Aortic Stenosis
T H E P A R T N E R T R I A L E S T A B L I S H I N G T H E N E w S T A N D A R D o f C A R E f o R I N o P E R A B L E A o R T I C S T E N o S I S
The Edwards SAPiEN THV Significantly improves Hemodynamics and Sustains Valve Performance
The Edwards SAPiEN THV Significantly improves Patient Symptoms and Quality of Life (QOL)
• Increase in ejection fraction at 1 year (P < .01)1
• Reduction in left ventricular mass index at 6 months and 1 year (P < .0001)1
• Reduction in mitral regurgitation at 1 year (P < .001)1
KCCQ, Kansas City Cardiomyopathy Questionnaire; MCID, minimum clinically important difference.
• 20-point improvement in KCCQ score represents change of large
clinical importance3
44.6
43.2
33.0
10.8
39.5
11.3
44.4
12.1
Me
an
Gra
die
nt,
mm
Hg 70
60
50
40
30
20
10
0 Baseline 30 Days 6 Months 1 Year N = 163 N = 143 N = 100 N = 89
P < .001Error bars = ± 1 SD
Standard TherapyEdwards THV
mEAN GRADIENTS oVER TImE1
KC
CQ
Sc
ore
70
60
50
40
30
20
10
0
∆ = 13.9P < .001
∆ = 20.7P < .001
∆ = 24.5P < .001
MCID = 5 ptsEdwards THV
Control
Months
0 2 4 6 8 10 12
KCCQ SCoRES oVER TImE1 AoRTIC VALVE AREAS (AVA) oVER TImE1
AV
A, c
m2
2.5
2.0
1.5
1.0
0.5
0
0.64
0.65
1.53
0.77
1.61
0.68
1.57
0.70
Baseline 30 Days 6 Months 1 Year N = 163 N = 143 N = 100 N = 89
P < .001Error bars = ± 1 SD
Standard TherapyEdwards THV
• Significant improvement observed as early
as 30 days (P < .001)2
I
II
III
IVPa
tie
nts
, %
100
80
60
40
20
0 Edwards Standard Edwards Standard THV Therapy THV Therapy Baseline 1 Year
P = .68 P < .001
NyHA CLASS oVER TImE2
Reduced mean gradient
(P < .001)2
Increased and sustained aortic
valve area (P < .001)2
25-point treament effect in KCCQ score
75% of the Edwards SAPiEN THV patients in
NYHA class i or ii at 1 year 2
T H E P A R T N E R T R I A L E S T A B L I S H I N G T H E N E w S T A N D A R D o f C A R E f o R I N o P E R A B L E A o R T I C S T E N o S I S
The Edwards SAPiEN THV Significantly improves Hemodynamics and Sustains Valve Performance
The Edwards SAPiEN THV Significantly improves Patient Symptoms and Quality of Life (QOL)
• Increase in ejection fraction at 1 year (P < .01)1
• Reduction in left ventricular mass index at 6 months and 1 year (P < .0001)1
• Reduction in mitral regurgitation at 1 year (P < .001)1
KCCQ, Kansas City Cardiomyopathy Questionnaire; MCID, minimum clinically important difference.
• 20-point improvement in KCCQ score represents change of large
clinical importance3
44.6
43.2
33.0
10.8
39.5
11.3
44.4
12.1
Me
an
Gra
die
nt,
mm
Hg 70
60
50
40
30
20
10
0 Baseline 30 Days 6 Months 1 Year N = 163 N = 143 N = 100 N = 89
P < .001Error bars = ± 1 SD
Standard TherapyEdwards THV
mEAN GRADIENTS oVER TImE1
KC
CQ
Sc
ore
70
60
50
40
30
20
10
0
∆ = 13.9P < .001
∆ = 20.7P < .001
∆ = 24.5P < .001
MCID = 5 ptsEdwards THV
Control
Months
0 2 4 6 8 10 12
KCCQ SCoRES oVER TImE1 AoRTIC VALVE AREAS (AVA) oVER TImE1
AV
A, c
m2
2.5
2.0
1.5
1.0
0.5
0
0.64
0.65
1.53
0.77
1.61
0.68
1.57
0.70
Baseline 30 Days 6 Months 1 Year N = 163 N = 143 N = 100 N = 89
P < .001Error bars = ± 1 SD
Standard TherapyEdwards THV
• Significant improvement observed as early
as 30 days (P < .001)2
I
II
III
IVPa
tie
nts
, %
100
80
60
40
20
0 Edwards Standard Edwards Standard THV Therapy THV Therapy Baseline 1 Year
P = .68 P < .001
NyHA CLASS oVER TImE2
Reduced mean gradient
(P < .001)2
Increased and sustained aortic
valve area (P < .001)2
25-point treament effect in KCCQ score
75% of the Edwards SAPiEN THV patients in
NYHA class i or ii at 1 year 2
T H E P A R T N E R T R I A L E S T A B L I S H I N G T H E N E w S T A N D A R D o f C A R E f o R I N o P E R A B L E A o R T I C S T E N o S I S
“ on the basis of a rate of death from any cause at 1 year that was 20 percentage points lower with TAVI than with standard therapy, balloon-expandable TAVi should be the new standard of care for patients with aortic stenosis who are not suitable candidates for surgery.”
— The PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. Oct 2010 2
“ Rarely in medical research has so dramatic an improvement in survival been achieved in such a short time, with so few iterations.”
— Lars Svensson, MD, PhD, Cardiothoracic Surgeon, Cleveland Clinic, Cleveland, Ohio
“ The dramatic improvement in quality of life scores in the Edwards SAPIEN THV group is equivalent to a 10-year reduction in age.”
— David J. Cohen, MD, PhD, Cardiologist and Director of Cardiovascular Research, St Luke’s Mid America Heart and Vascular Institute, Kansas City, Missouri
with standard therapy, predicted survival of inoperable patients with aortic stenosis is lower than with certain metastatic cancers
Based on 1-year results of Cohort B patients treated with the Edwards SAPIEN THV:
Critical insights
to save a life1 5only need to treat
patientsout of
patients were asymptomatic or mildly
symptomatic2
3 4
Increased experience and next-generation technology may lower the incidence of acute major complications:
• Vascular complications (16.2%)2
• Bleeding episodes (16.8%)2
• Strokes (5.0%)2
*Using constant hazard ratio
23
Breast4 Lung4 Colorectal4 Prostate4 Ovarian4 Severe Inoperable AS*1
412
30
3
28
5-yEAR SuRVIVAL RATE, %
*Using constant hazard ratio.
T H E P A R T N E R T R I A L E S T A B L I S H I N G T H E N E w S T A N D A R D o f C A R E f o R I N o P E R A B L E A o R T I C S T E N o S I S
“ on the basis of a rate of death from any cause at 1 year that was 20 percentage points lower with TAVI than with standard therapy, balloon-expandable TAVi should be the new standard of care for patients with aortic stenosis who are not suitable candidates for surgery.”
— The PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. Oct 2010 2
“ Rarely in medical research has so dramatic an improvement in survival been achieved in such a short time, with so few iterations.”
— Lars Svensson, MD, PhD, Cardiothoracic Surgeon, Cleveland Clinic, Cleveland, Ohio
“ The dramatic improvement in quality of life scores in the Edwards SAPIEN THV group is equivalent to a 10-year reduction in age.”
— David J. Cohen, MD, PhD, Cardiologist and Director of Cardiovascular Research, St Luke’s Mid America Heart and Vascular Institute, Kansas City, Missouri
with standard therapy, predicted survival of inoperable patients with aortic stenosis is lower than with certain metastatic cancers
Based on 1-year results of Cohort B patients treated with the Edwards SAPIEN THV:
Critical insights
to save a life1 5only need to treat
patientsout of
patients were asymptomatic or mildly
symptomatic2
3 4
Increased experience and next-generation technology may lower the incidence of acute major complications:
• Vascular complications (16.2%)2
• Bleeding episodes (16.8%)2
• Strokes (5.0%)2
*Using constant hazard ratio
23
Breast4 Lung4 Colorectal4 Prostate4 Ovarian4 Severe Inoperable AS*1
412
30
3
28
5-yEAR SuRVIVAL RATE, %
*Using constant hazard ratio.
Edwards Lifesciences Irvine, USA I Nyon, Switzerland I Tokyo, Japan I Singapore, Singapore I São Paulo, Brazil edwards.com
The Edwards SAPIEN transcatheter heart valve and delivery systems bearing the CE conformity marking comply with the requirements of the European Medical Device Directive 93/42/EEC. For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions, and adverse events.
Caution: not intended for uS distribution.
Edwards is a trademark of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, and PARTNER are trademarks of Edwards Lifesciences Corporation and registered in the United States Patent and Trademark Office.
© 2010 Edwards Lifesciences Corporation. All rights reserved. E1679/11-10/THV
References
1. Data on file, Edwards Lifesciences LLC. 2. Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363;1597-1607. 3. Spertus J, Peterson E, Conrad MW, et al. Monitoring clinical changes in patients with heart failure: a comparison of methods. Am Heart J. 2005;150:707-715. 4. National Institutes of Health. National Cancer Institute. Surveillance Epidemiology and End Results. Cancer Fact Sheets. http://seer.cancer.gov/statfacts/. Accessed November 16, 2010.
Establishing the New Standard of Care for Inoperable Aortic Stenosis
THE PARTNER TRIALCOHORT B RESULTS
E D W A R D S T R A N S C A T H E T E R H E A R T V A L V E P R O G R A M
• Superior survival
• Significantly improved cardiac function
• Dramatic reduction in symptoms
• Restored quality of life
A New Lifeline for Inoperable Aortic Stenosis Patients
T h e E d w a r d s S A P I E N T r a n s c a t h e t e r H e a r t V a l v e