1. Craig R. Smith, MD on behalf of The PARTNER Trial Investigators
Transcatheter vs. Surgical Aortic Valve Replacement in High Risk Patients with Severe Aortic Stenosis: Results From The PARTNER Trial
Craig R. Smith, MD
on behalf of The PARTNER Trial Investigators
ACC | New Orleans | April 3, 2011

2. Presenter Disclosure Information for PARTNER at ACC April 3, 2011
Craig R. Smith, MD
PARTNER Trial sponsor (Edwards LifeSciences) reimburses customary travel and other expenses

3. Background
Surgical aortic valve replacement (AVR) is the standard of care for treating patients with symptomatic aortic stenosis who are candidates for operation.
Although transcatheter aortic valve replacement (TAVR) reduces mortality in patients who cannot have AVR, there have been no randomized trials comparing TAVR to AVR in patients who are at high-risk for operation.

4. Purpose
To compare the safety and effectiveness of TAVR (either transfemoral or transapical) to surgical AVR in high-risk, operable patients with symptomatic, severe aortic stenosis.

5. PARTNER Study Design Inoperable N = 699 High Risk N = 358
Symptomatic Severe Aortic Stenosis
ASSESSMENT: High-Risk AVR Candidate
3,105 Total Patients Screened
Total = 1,057 patients
2 Parallel Trials: Individually Powered
N = 699
N = 358
High Risk
Inoperable
Standard
Therapy
ASSESSMENT: Transfemoral Access
Not In Study
TF TAVR
Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority)
Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority)
1:1 Randomization VS
Yes No
N = 179

6. Inoperable PARTNER Cohort Primary Endpoint: All-Cause Mortality
HR [95% CI] = 0.54 [0.38, 0.78]
P (log rank) <
Standard Rx
TAVI
∆ at 1 yr = 20.0% NNT = 5.0 pts
50.7%
All-cause mortality (%)
30.7%
Months
Leon et al, NEJM 2010; 363:
Numbers at Risk
TAVI
179
138
122 67 26
Standard Rx
121 83 41 12 6

7. PARTNER Study Design High Risk Inoperable N = 699 N = 358
Symptomatic Severe Aortic Stenosis
ASSESSMENT: High-Risk AVR Candidate
3,105 Total Patients Screened
N = 179
N = 358
Inoperable
Standard
Therapy
ASSESSMENT: Transfemoral Access
Not In Study
TF TAVR
Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority)
Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority)
1:1 Randomization VS
Yes No
Total = 1,057 patients
High Risk
N = 699
2 Parallel Trials: Individually Powered
ASSESSMENT: Transfemoral Access
Transapical (TA)
Transfemoral (TF)
1:1 Randomization
Yes No
TF TAVR
AVR
Primary Endpoint: All-Cause Mortality at 1 yr (Non-inferiority)
TA TAVR VS
N = 248
N = 104
N = 103
N = 244

8. Primary Endpoint All-cause mortality at one year
Analysis by intent-to-treat
Event rates by Kaplan-Meier estimates
Crossovers permitted only when assigned therapy unsuccessful
All patients followed for ≥ one year

9. Other Important Endpoints (1)
Safety:
Neurologic events
Prospective: Stroke and stroke plus TIA (all neuro events)
Retrospective: Major stroke (modified Rankin Score ≥ ≥ 30 days)
Major vascular complications (VARC definition)
Major bleeding (modified VARC definition)
Repeat hospitalization
New pacemakers and new-onset atrial fibrillation (ECG core lab)
Procedural events (assigned therapy aborted or converted to AVR, multiple valves, etc.)
Surgical complications (re-op for bleeding, sternal infection, etc.)

10. Other Important Endpoints (2)
Clinical Effectiveness and Valve Performance:
NYHA symptoms
Six-minute walk tests
Quality-of-life measures and cost-effectiveness (core lab)
Echocardiography assessment of valve performance (core lab)
Peak and mean gradients
Effective orifice area
Bioprosthetic valve regurgitation (esp. para-valvular)
Other: LV ejection fraction, MR, LV mass, evidence of structural valve deterioration

11. Study Administration Co-Principal Investigators
Martin B. Leon, Craig R. Smith Columbia University Medical Center
Executive Committee
Martin B. Leon, Michael Mack, D. Craig Miller, Jeffrey W. Moses, Craig R. Smith, Lars G. Svensson, E. Murat Tuzcu, John G. Webb
Data & Safety Monitoring Board
Chairman: Joseph P. Carrozza Tufts University School of Medicine
Clinical Events Committee
Chairman: John L. Petersen Duke University Medical Center
Echo Core Laboratory
Chairman: Pamela C. Douglas Duke University Medical Center
Quality of Life and Cost-Effectiveness
Chairman: David J. Cohen Mid America Heart Institute, Kansas City
Independent Biostatistical Core Laboratory
Stuart Pocock, Duolao Wang London School of Hygiene and Tropical Medicine
William N. Anderson
Publications Committee
Co-Chairman: Jeffrey W. Moses Lars G. Svensson
Sponsor
Edwards Lifesciences: Jodi J. Akin

12. Executive Committee Lars Svensson Craig Miller Michael Mack Jeff Moses
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Murat Tuzcu
Craig Smith
John Webb
Marty Leon 12

13. Participating Study Sites
St. Paul's Hospital
Vancouver, Canada
Univ. of Washington Seattle, WA
Hospital Laval
Quebec City, Canada
Toronto Gen. Hospital
Toronto, Canada
Mayo Clinic
Rochester, MN
Intermountain
Medical Center
Salt Lake City, UT
Brigham & Women’s
Mass General
Boston, MA
Stanford University
Palo Alto, CA
Evanston Hospital
Northwestern Univ.
Chicago, IL
Univ. of Penn
Phila., PA
Columbia University
Cornell University
New York, NY
Cleveland Clinic
Cleveland, OH
Barnes-Jewish Hospital St. Louis, MO
Washington
Hosp. Center
Wash., DC
Cedars-Sinai
Medical Center
Los Angeles, CA
St. Luke’s Hospital
Kansas City, MO
Univ. of Virginia
Charlottesville, VA
Scripps Clinic
La Jolla, CA
Emory University
Atlanta, GA
Medical
City Dallas
Dallas, TX
Leipzig Heart Center
Leipzig, Germany
Ochsner Foundation
New Orleans, LA
Univ. of Miami
Miami, FL
n = 1,057 patients
26 investigator sites
22 USA, 3 Canada, 1 Germany

14. High-Risk Enrollment by Site
Cedars-Sinai Medical Ctr Los Angeles, CA G. Fontana, R. Makkar
116
Columbia University New York City, NY M. Leon, C. Smith 97
Medical City Dallas
Dallas, TX
D. Brown, T. Dewey 95
Emory University
Atlanta, GA
P. Block, R. Guyton 67
University of Pennsylvania
Philadelphia, PA
J. Bavaria, H. Herrmann 52
Cleveland Clinic Found
Cleveland, OH
L. Svensson, M. Tuzcu 47
Washington Hospital Ctr
District of Columbia
P. Corso, A. Pichard 40
University of Miami
Miami, FL
W. O’Neill, D. Williams 25
Barnes-Jewish Hospital
St. Louis, MO
R. Damiano, J, Lasala 24
Stanford University
Palo Alto, CA
C. Miller, A. Yeung 23
Northwestern University
Chicago, IL
C. Davidson, P. McCarthy 20
St. Paul's Hospital
Vancouver, BC, Canada
A. Cheung, J. Webb 19

15. High-Risk Enrollment by Site
Mass General Hospital Boston, MA I. Palacios, G. Vlahakis 15
St. Luke’s Hospital Kansas City, MO K. Allen, D. Cohen 13
Universitaire de Quebec
Laval, Quebec, CA
D. Doyle, J. Rodes-Cabau 8
Scripps Clinic
La Jolla, CA
S. Brewster, P. Teirstein 7
Herzzentrum Leipzig
Leipzig, Germany
F. Mohr, G. Schuler
Mayo Clinic
Rochester, MN
C. Rihal, T. Sundt 6
Univ of Washington
Seattle, WA
M. Reisman, E. Verrier 5
Northshore Univ Health Sys
Evanston, IL
J. Alexander, T. Feldman 4
University of Virginia
Charlottesville, VA
I. Kron, S. Lim 3
Brigham & Women’s Hosp
Boston, MA
M. Davidson, A. Eisenhauer 2
Ochsner Foundation
New Orleans, LA
E. Parrino, S. Ramee
Intermountain Med Center
Salt Lake City, UT
K. Jones, B. Whisenant 1
Cornell University
New York City, NY
K. Krieger, C. Wong
Toronto General Hospital
Toronto, Ontario, CA
C. Feindel, E. Horlick

16. Study Devices Edwards SAPIEN THV RetroFlex Ascendra
23 and 26 mm valves
RetroFlex
22 and 24 F sheaths
Ascendra
24 and 26 F sheaths

17. Transfemoral and Transapical
TAVR
Transfemoral and Transapical
Transfemoral
Transapical

18. Inclusion Criteria
• Severe AS: Echo-derived AVA < 0.8 cm2 (or AVA index < 0.5 cm2/m2) and mean AVG > 40 mm Hg or peak jet velocity > 4.0 m/s
• Cardiac Symptoms: NYHA Functional Class ≥ II
High surgical risk: Predicted risk of operative mortality ≥ 15% (determined by site surgeon and cardiologist); guideline = STS score ≥ 10

19. Key Exclusion Criteria (1)
Anatomic:
Bicuspid or non-calcified aortic valve
Aortic annulus diameter (echo measurement) < 18 mm or > 25 mm
Aortic dissection or iliac-femoral dimensions or disease precluding safe sheath insertion (esp. calcification)
Severe LV dysfunction (LVEF < 20%)
Untreated CAD requiring revascularization
Severe AR or MR (> 3+) or prosthetic valve (any location)

20. Key Exclusion Criteria (2)
Clinical:
Serum Cr > 3.0 mg/dL or dialysis dependent
Acute MI within 1 month
Upper GI bleed within 3 months
CVA or TIA within 6 months
Any cardiac procedure, other than BAV, within 1 month or within 6 months for DES
Hemodynamic instability (e.g. requiring inotropic support)

21. Statistical Analysis Plan
Primary hypothesis is non-inferiority of test (TAVR) vs. control (AVR) for all-cause mortality at 1 year
Non-inferior if one-sided 95% upper confidence limit for the treatment difference is < 7.5% (α =0.05)
Primary Endpoint: All TF and TA patients
Assuming true 1-year mortality 32% after AVR and 29% after TAVR
Intended sample size = 650 patients for ≥ 85% power
Powered Secondary Endpoint: Only TF patients
Assuming true 1-year mortality 35% after AVR and 25% after TAVR
Intended sample size = 450 patients for ≥ 85% power

22. Study Methodology
Preliminary eligibility determined by site investigators
Every case reviewed by web-based conference call before enrollment
Randomized to TF-TAVR vs. AVR, or TA-TAVR vs. AVR, to be treated within 2 weeks
Intent-to-treat (ITT) analysis for the primary and most secondary endpoints; defined as the time of randomization
As-treated (AT) analysis for some procedural endpoints and for echo assessments; defined as the time of procedural anesthesia induction

23. 42 Patients not treated as assigned
Study Flow
Randomized = 699 patients
Transfemoral n = 492
TF = 492
TA = 207
Transapical n = 207
TAVR (244)
AVR (248)
TAVR (104)
AVR (103)
30 Days (236)
Dead = 8
Withdrawal = 0
30 Days (223)
Dead = 15
Withdrawal = 10
30 Days (100)
Dead = 4
Withdrawal = 0
30 Days (92)
Dead = 7
Withdrawal = 4
1 Year (189)
Dead = 46
Withdrawal = 1
1 Year (168)
Dead = 47
Withdrawal = 8
1 Year (73)
Dead = 26
Withdrawal = 0
LTFU = 1
1 Year (68)
Dead = 20
Withdrawal = 3
LTFU = 1
42 Patients not treated as assigned

24. Reasons for Non-treatment
ITT = 699 patients │ AT = 657 patients
Reason
TAVR (N = 348)
AVR (N = 351)
Died before treatment - no. (%)
2 (0.6)
5 (1.4)
Deterioration before treatment - no. (%)
1 (0.3)
Refusal - no. (%)
17 (4.8)
Withdrawal - no. (%)
11 (3.1)
Total – no. (%)
4 (1.1)
38 (10.8)
NOTE: Time from randomization to treatment = TAVR 10.6 [SEM 0.7] days vs. AVR 15.6 [SEM 1.1] days; P <0.001

25. Patient Characteristics (1)
TAVR (N = 348)
AVR (N = 351)
p-value
Age (yr)
83.6 ± 6.8
84.5 ± 6.4
0.07
Male sex - %
57.8
56.7
0.82
STS Score
11.8 ± 3.3
11.7 ± 3.5
0.61
Logistic EuroSCORE
29.3 ± 16.5
29.2 ± 15.6
0.93
NYHA II - %
III or IV - %
94.3
94.0
0.79
CAD - %
74.9
76.9
0.59
Previous MI - %
26.8
30.0
0.40
Prior CV Intervention - %
72.1
71.6
Prior CABG - %
42.6
44.2
0.70
Prior PCI - %
34.0
32.5
0.68
Prior BAV - %
13.4
10.2
0.24
29.3
27.4
0.60
5.7
6.0
Cerebrovascular disease - %

26. Patient Characteristics (2)
TAVR (N = 348)
AVR (N = 351)
p-value
Peripheral vascular disease - %
43.0
41.6
0.76
COPD
Any
43.4
Oxygen dependent
9.2
7.1
0.34
Creatinine > 2mg/dL - %
11.1
7.0
0.06
Atrial fibrillation - %
40.8
42.7
0.75
Permanent pacemaker - %
20.0
21.9
0.58
Pulmonary hypertension - %
42.4
36.4
0.15
Frailty - %
15.6
17.6
Porcelain aorta - %
0.6
1.1
0.69
Chest wall radiation - %
0.9
1.00
Liver disease - %
2.0
2.6
0.80
43.0
0.94

27. Baseline Echocardiography
Echo Findings
TAVR (N = 348)
AVR (N = 351)
p-value
AVA - cm2
0.7 ± 0.2
0.6 ± 0.2
0.13
AVG - mm Hg
42.7 ± 14.6
43.5 ± 14.3
0.45
Mean LVEF - %
52.5 ± 13.5
53.3 ± 12.8
Moderate or severe MR - %
19.8
21.3
0.63

28. Procedural Outcomes - TAVR vs AVR
Anesthesia time - min
330
Total procedure time - min
230
Aborted procedure - no. (%)
Reoperation for bleeding - no. (%)
12 (3.4)
Intra-procedural death - no. (%)
1 (0.3)
Aortic perforation - no. (%)
Aortic dissection - no. (%)
3 (0.9)
Median ICU stay (days)
5.0
Anesthesia time - min
236
Total procedure time - min
133
Aborted procedure - no. (%)
7 (2.0)
Reoperation for bleeding - no. (%)
2 (0.6)
Intra-procedural death - no. (%)
3 (0.9)
Aortic perforation - no. (%)
Aortic dissection - no. (%)
Median ICU stay (days)
3.0
3 failed access
2 new TEE findings
2 died
Aborted procedure - no. (%)
*Converted to transapical TAVR due to porcelain aorta

29. Procedural Outcomes - TAVR vs AVR
Sternal wound infection - no. (%)
7 (2.0)
Total cross clamp time - min 74
Pump time - min
105
Access site infection - no. (%)
7 (2.0)
Fluoroscopy time - min 31
Converted to AVR - no. (%)
9 (2.6)
Multiple (≥2) valves - no. (%)
Valve embolization - no. (%)
5 valve embolization
3 annulus size on TEE
1 large sigmoid septum
Converted to AVR - no. (%)
5 converted to AVR
2 valve-in-valve
2 not treated
Valve embolization - no. (%)
*Converted to transapical TAVR due to porcelain aorta

30. Primary Endpoint: All-Cause Mortality at 1 Year
HR [95% CI] = 0.93 [0.71, 1.22]
P (log rank) = 0.62
0.5
TAVR
AVR
0.4
26.8
0.3
0.2
24.2
0.1 6 12 18 24
No. at Risk
Months
TAVR
348
298
260
147 67
351
252
236
139 65
AVR

31. Primary Endpoint: All-Cause Mortality at 1 Year
AVR (N = 351)
26.8%
TAVR (N = 348)
24.2%
Primary Non-Inferiority Endpoint Met
Non-inferiority P value
= 0.001
Difference -2.6%
Upper 1-sided 95% CI 3.0%
Zone of non-inferiority pre-specified margin = 7.5%
Non-inferior
-3.0
-2.0
-1.0
0.0
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0 %
Upper one-sided 95% CI

32. All-Cause Mortality Transfemoral (N=492)
HR [95% CI] = 0.83 [0.60, 1.15]
P (log rank) = 0.25
26.4
22.2
No. at Risk
Months
TAVR
244
215
188
119 59
248
180
168
109 56
AVR

33. Powered Secondary Endpoint (ITT): TF All-Cause Mortality at 1 Year
TAVR (N = 248)
22.2%
AVR (N = 244)
26.4%
Difference -4.2%
Upper 1-sided 95% CI 2.3%
Non-inferiority P value
= 0.002
Zone of non-inferiority pre-specified margin = 7.5%
Non-inferior
-5.0
-4.0
-3.0
-2.0
-1.0
0.0
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0 %
Upper one-sided 95% CI
Secondary TF Non-Inferiority Endpoint Met

34. All-Cause Mortality Transapical (N=207)
HR [95% CI] = 1.22 [0.75, 1.98]
P (log rank) = 0.41
29.0
27.9
No. at Risk
Months
TAVR
104 83 72 28 8
103 68 30 9
AVR

35. Surgical AVR Outcomes
Using an established predictive risk model (STS), the expected (“E”) 30-day mortality after AVR was 11.8%.
The observed (“O”) 30-day mortality in the as-treated AVR control group was 8.0%.
O:E = 0.68 indicates better than predicted surgical outcomes in the control AVR patients.
There were no significant site or surgeon differences. 35

36. All-Cause Mortality at 30 Days and 1 Year Patient Subgroups
All Patients no. of patients ( %)
TF Patients
no. of patients ( %)
TA Patients
TAVR
AVR
p-value
ITT
12 (3.4)
22 (6.5)
0.07
8 (3.3)
15 (6.2)
0.13
4 (3.8)
7 (7.0)
0.32 AT
18 (5.2)
25 (8.0)
0.15
9 (3.7)
18 (8.2)
0.05
9 (8.7)
7 (7.6)
0.79
All-Cause Mortality at 1 Year
All Patients no. of patients ( %)
TF Patients
no. of patients ( %)
TA Patients
TAVR
AVR
p-value
ITT
84 (24.2)
89 (26.8)
0.44
54 (22.2)
62 (26.4)
0.29
30 (29.0)
27 (27.9)
0.85 AT
81 (23.7)
78 (25.2)
0.64
51 (21.3)
55 (25.2)
0.33
30 (29.1)
23 (25.3)
0.55

37. Clinical Outcomes at 30 Days and 1 Year All Patients (N=699)
30 Days
1 Year
Outcome
TAVR (N = 348)
AVR (N = 351)
p-value
TAVR
(N = 348)
All mortality – no. (%)
12 (3.4)
22 (6.5)
0.07
84 (24.2)
89 (26.8)
0.44
Cardiac mortality – no. (%)
11 (3.2)
10 (3.0)
0.90
47 (14.3)
40 (13.0)
0.63
Rehospitalization – no. (%)
15 (4.4)
12 (3.7)
0.64
58 (18.2)
45 (15.5)
0.38
Death or rehosp – no. (%)
25 (7.2)
33 (9.7)
0.24
120 (34.6)
119 (35.9)
0.73
MI – no. (%)
2 (0.6)
0.16
1 (0.4)
0.69
Acute kidney inj* – no. (%)
10 (2.9)
0.95
18 (5.4)
20 (6.5)
0.56
* Renal replacement therapy

38. Clinical Outcomes at 30 Days and 1 Year All Patients (N=699)
30 Days
1 Year
Outcome
TAVR (N = 348)
AVR (N = 351)
p-value
TAVR
(N = 348)
Vascular complications
All – no. (%)
59 (17.0)
13 (3.8)
<0.01
62 (18.0)
16 (4.8)
Major – no. (%)
38 (11.0)
11 (3.2)
39 (11.3)
12 (3.5)
Major bleeding – no. (%)
32 (9.3)
67 (19.5)
49 (14.7)
85 (25.7)
Endocarditis – no. (%)
0 (0.0)
1 (0.3)
0.32
2 (0.6)
3 (1.0)
0.63
New AF – no. (%)
30 (8.6)
56 (16.0)
< 0.01
42 (12.1)
60 (17.1)
0.07
New PM – no. (%)
12 (3.6)
0.89
19 (5.7)
16 (5.0)
0.68
NOTE: Original idea was to create TWO OPTIONS – HOWEVER, given the amount of content – Option 2 would take a total of 4 slides. I can create these slides easily, but wanted you to review Option 1 before investing time in the creation of those slides.
Here’s the original discussion: Clinical 30 Day & 1 year: Table 2 from Pages 30 & 31 of Manuscript
Option 1 = Both 30 Day & 1 Year side-by-side in 1 slide
Option 2 = 1 slide for 30 Day / 1 slide for 1 Year 38

39. Neurological Events at 30 Days and 1 Year All Patients (N=699)
30 Days
1 Year
Outcome
TAVR (N = 348)
AVR (N = 351)
All Stroke or TIA – no. (%)
19 (5.5)
8 (2.4)
0.04
27 (8.3)
13 (4.3)
TIA – no. (%)
3 (0.9)
1 (0.3)
0.33
7 (2.3)
4 (1.5)
0.47
All Stroke – no. (%)
16 (4.6)
0.12
20 (6.0)
10 (3.2)
0.08
Major Stroke – no. (%)
13 (3.8)
7 (2.1)
0.20
17 (5.1)
0.07
Minor Stroke – no. (%)
0.34
2 (0.7)
0.84
Death/maj stroke – no. (%)
24 (6.9)
28 (8.2)
0.52
92 (26.5)
93 (28.0)
0.68
p-value
p-value

40. All-Cause Mortality or Stroke All Patients (N=699)
HR [95% CI] = 0.95 [0.73, 1.23]
P (log rank) = 0.70
28.0
26.5
No. at Risk
Months
TAVR
348
289
252
143 65
351
247
232
138 63
AVR

41. NYHA Functional Class Patients Surviving, % P = 1.00 P < 0.001
Baseline
30 Days
6 Months
1 Year I II
III IV

42. Six-Minute Walk Test All Patients (N=699)
Median Distance, meters

43. Subgroup Analyses of Treatment Effect All-Cause Mortality at 1 Year
TAVR (%)
n=348
AVR (%) n=351
RR (95% CI)
P-value for interaction
Overall
24.1
25.4
0.95( )
Age
<85
>85
21.6
27.0
24.9
26.1
0.87( )
1.03( )
0.52
Sex
Male
Female
28.4
18.4
24.2
27.2
1.17( )
0.045
BMI
<26
>26
27.3
21.0
27.4
23.8
0.68( )
0.99( )
0.66
STS score
<11
>11
19.9
28.1
21.7
29.3
0.88( )
0.92( )
0.87
LV ejection fraction
<55
>55
26.2
22.4
27.7
22.1
0.96( )
1.01( )
0.80
TAVR better
AVR better
0.5 1 2

44. Subgroup Analyses of Treatment Effect All-Cause Mortality at 1 Year
TAVR (%)
n=348
AVR (%) n=351
RR (95% CI)
P-value for interaction
Pulmonary hypertension No
Yes
21.3
27.4
21.7
29.9
0.98( )
0.92( )
0.80
Mitral regurgitation
24.6
24.2
22.1
35.2
1.11( )
0.69( )
0.12
Prior CABG
22.2
25.9
30.7
19.1
0.72( )
1.35( )
0.02
Peripheral vasc disease
22.4
26.4
25.1
25.4
0.89( )
1.04( )
0.57
Cohort TA TF
28.8
26.2
25.0
1.10( )
0.89( )
0.43
TAVR better
AVR better
0.5 1 2

45. Echo Findings Aortic Valve Gradients
Mean and Peak Gradient As-Treated Trial Arms (mmHg) 50 40 30 20 60 70 10 80
Mean Gradient - AVR
Mean Gradient - TAVR
Peak Gradient - AVR
Peak Gradient - TAVR
Baseline
30 Days
6 Months
1 Year
TAVR n = 327
AVR n = 301
TAVR n = 287
AVR n = 231
TAVR n = 246
AVR n = 170
TAVR n = 227
AVR n = 159

46. Echo Findings Hemodynamic Assessments
30 Days
1 Year
Finding
TAVR
AVR
AVG – mmHg
9.9 ± 4.8
10.8 ± 5.0
0.04
10.2 ± 4.3
11.5 ± 5.4
0.008
AVA - cm2
1.7 ± 0.5
1.5 ± 0.4
0.001
1.6 ± 0.5
1.4 ± 0.5
0.002
LVEF - %
55.5 ± 11.4
56.0 ± 11.4
0.63
56.6 ± 10.5
57.1 ± 10.3
0.64
p-value
p-value

47. Paravalvular Aortic Regurgitation
Patients, %
30 Days
6 Months
1 Year
None
Trace
Mild
Moderate
Severe

48. Study Limitations
8% of the control (AVR) group withdrew or refused assigned therapy
5% of patients randomized to TAVR did not receive assigned therapy (procedure aborted or converted to AVR)
Significantly longer interval between randomization and treatment in controls (AVR)
An early version large TAVR delivery system was used
Most sites had no previous TAVR experience - learning curve impact inherent in TAVR, but not in AVR
Insufficient statistical power to compare TA to either AVR or TF
Long-term follow-up not available to assess TAVR durability
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49. Conclusions (1) The primary endpoint of the trial was met:
In patients with aortic stenosis at high risk for operation, TAVR was non-inferior to AVR for all-cause mortality at 1 year (24.2% vs. 26.8%, p=0.001 for non inferiority)
Transfemoral TAVR subgroup was also non-inferior to AVR (p=0.002 for non-inferiority)
Death at 30 days was lower than expected in both arms of the trial:
TAVR mortality (3.4%) was the lowest reported in any series, despite an early generation device and limited previous operator experience
AVR mortality (6.5%) was lower than the expected operative mortality (11.8%)
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50. Conclusions (2)
Both TAVR and AVR were associated with important but different peri-procedural hazards:
Major strokes at 30 days (3.8 vs. 2.1%, p=0.20) and one year (5.1% vs. 2.4%, p=0.07) and major vascular complications were more frequent with TAVR (11.0% vs. 3.2%, p<0.001)
Major bleeding (9.3% vs. 19.5%, p<0.001) and new onset atrial fibrillation (8.6% vs. 16.0%, p<0.001) were more frequent with AVR
TAVR and AVR are both acceptable therapies in these high-risk patients; differing peri-procedural hazards should influence case-based decision-making
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51. Conclusions (3)
Symptom improvement (NYHA class and 6-min walk distance) favored TAVR at 30 days and was similar to AVR at one year
Echo findings indicate:
Small hemodynamic benefit with TAVR vs. AVR at 1 year (mean gradient p=0.008, AVA p=0.002)
Increased para-valvular regurgitation associated with TAVR (p<0.001)
Preliminary subgroup analyses should be interpreted cautiously:
Possible TAVR benefit in women and patients without prior CABG
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52. Implications
A multidisciplinary valve team approach benefits patients and is recommended for all future valve centers.
TAVR is already the standard-of-care for inoperable patients with severe aortic stenosis. These results indicate that TAVR is an acceptable alternative to AVR in selected high-risk operable patients.
Future randomized studies should focus on lower risk patients who are candidates for operation.

53. End

54. PARTNER Comparison of Outcomes High-Risk vs. Inoperable Patients
Per Cent (%)
11.0
5.0