1. Outcomes in the CoreValve US High-Risk Pivotal Trial in Patients with a Society of Thoracic Surgeons Predicted Risk of Mortality Less than or Equal to 7%
Michael J. Reardon, MD1; David H. Adams, MD2; Neal S. Kleiman, MD1; G. Michael Deeb, MD3; Steven J. Yakubov, MD4; George L. Zorn III, MD5; and Jeffrey J. Popma, MD6
1Houston-Methodist-Debakey Heart and Vascular Center, Houston, TX; 2Mount Sinai Health System, New York, NY; 3University of Michigan Hospitals, Ann Arbor, MI; 4Riverside Methodist Hospital, Columbus, OH; 5 University of Kansas, Kansas City, KS 6Beth Israel Deaconess Medical Center, Boston, MA

2. Background
Transcatheter aortic valve replacement (TAVR) is now a well-accepted alternative to surgical AVR for patients with severe, symptomatic aortic stenosis (AS) at increased operative risk. There is increased interest in how TAVR will perform in lower-risk populations.
We hypothesized that as risk decreases, the contribution to survival based on the degree of invasiveness of the treatment procedure will decrease, making it more difficult for TAVR to show improved survival over SAVR.
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3. Methods
The CoreValve US Pivotal High Risk Trial recruited patients with severe AS who were at increased surgical risk.
Patients were randomized (1:1) to self-expanding TAV (TAVR group) or to surgical AVR (SAVR group)
Retrospectively stratified patients based on the overall population median Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) of 7%
Clinical outcomes and quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ) were assessed in patients with an STS PROM ≤7%.
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4. Definitions
An acceptable outcome was defined as being alive with a KCCQ summary score of <60 or a documented decrease in KCCQ of ≥10 points from baseline to the reported follow-up time point. A good medical benefit was defined as a KCCQ summary score of ≥60 and with < 10-point decrease from baseline
Patient prosthesis mismatch was defined as severe if the effective orifice area (EOA) index was ≤0.65 cm2/m2
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5. Baseline Characteristic, % or mean ± SD TAVR N=202 SAVR N=181 P Value
Age (years)
81.5 ± 7.6
81.2 ± 6.6
0.69
Men
57.9
55.8
0.68
STS – PROM (%)
5.1 ± 1.3
5.0 ± 1.2
0.51
NYHA Class III or IV
78.7
86.7
0.04
Previous CABG
29.2
28.7
0.92
Atrial fibrillation/flutter
34.2
38.7
0.36
Preexisting pacemaker or ICD
21.3
16.6
0.24
Peripheral vascular disease
36.2
38.0
0.72
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6. Comorbidities, Frailties, Disabilities
Characteristic, % or mean ± SD
TAVR N=202
SAVR N=181
P Value
Severe aortic calcification*
13.4
12.7
0.85
Severe chronic lung disease
9.4
6.1
0.23
Home oxygen
13.9
13.3
0.86
Albumin <3.3 g/dL
16.1
14.8
0.73
5-Meter gait speed >6 seconds
79.8
76.1
0.41
Grip strength below threshold
68.2
68.9
0.88
Assisted living
9.9
12.2
0.48
≥2 Katz ADL deficits
5.4
6.6
0.63
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7. Results

8. Months Post-Procedure
All-Cause Mortality
All-Cause Mortality
Log-rank P = 0.01
26.3
14.0
15.0
10.4
No. at Risk:
Months Post-Procedure
TAVR
202
182
128
SAVR
181
151 93
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9. Cardiovascular Mortality
Log-rank P = 0.06
19.5
10.8
11.7
8.4
No. at Risk:
Months Post-Procedure
TAVR
202
182
128
SAVR
181
151 93
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10. Other 2-Year Clinical Outcomes
KM rates (no. of patients)
TAVR N=202
SAVR N=181
P Value
All-cause mortality or major stroke
17.1 (34)
31.9 (55)
0.0018
Major stroke
6.1 (12)
10.1 (15)
0.309
Major vascular complication
8.2 (16)
2.2 (4)
0.013
Life-threatening or disabling bleeding
20.2 (44)
34.9 (67)
0.001
Acute kidney injury
5.0 (10)
15.6 (28)
0.0006
New atrial fibrillation/flutter
23.3 (47)
34.8 (63)
Permanent pacemaker
27.7 (56)
10.5 (18)
<0.0001
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11. Valve Performance
Significantly Better Hemodynamics with TAVR Post-procedure (All P< )
Aortic Valve Area, cm2
AV Mean Gradient, mm Hg
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12. Patient Prosthesis Mismatch
More SAVR Patients with Severe PPM at all Time Points (All P< )
Percentage of Patients
1 Month
6 Months
1 Year
2 Years
Patient-prosthesis mismatch was defined as severe if the effective orifice area (EOA) index was ≤0.65 cm2/m2. 12

13. Quality of Life
P=0.28
An acceptable outcome was defined as being alive with a KCCQ summary score of <60 or a documented decrease in KCCQ of ≥10 points from baseline to the reported follow-up time point. A good medical benefit was defined as a KCCQ summary score of ≥60 and with < 10-point decrease from baseline . 13

14. Conclusions In patients with an STS ≤ 7%:
TAVR was associated with significantly better survival and valve hemodynamics, and numerically better stroke
TAVR was associated with significantly less bleeding, acute kidney injury and new AF, but more vascular complications and need for a pacemaker
In patients with KCCQ data, TAVR and SAVR patients had similar rates of medical benefit
Findings from this post-hoc subgroup analysis show that TAVR may be a reasonable option for patients with an STS of 7% or less.
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