|
At 1 year
|
|
All-cause mortality, n (%)
|
62 (11.1%)
|
82 (14.7%)
|
1.35 (0.97-1.87)
|
0.077
|
1.19 (0.84-1.67)
|
0.329
|
|
Cardiovascular mortality, n (%)
|
38 (6.9%)
|
55 (10.1%)
|
1.47 (0.97-2.23)
|
0.067
|
1.28 (0.84-1.96)
|
0.258
|
|
Any stroke, n (%)
|
25 (4.5%)
|
28 (5.1%)
|
1.14 (0.67-1.96)
|
0.631
|
1.12 (0.65-1.95)
|
0.684
|
|
Major or life-threatening bleeding, n (%)
|
112 (19.9%)
|
166 (29.9%)
|
1.57 (1.23-1.99)
|
<0.001
|
1.49 (1.17-1.90)
|
0.001
|
|
Structural valve deterioration, n (%)
|
8 (1.5%)
|
4 (0.8%)
|
0.51 (0.15-1.68)
|
0.266
|
0.52 (0.16-1.76)
|
0.295
|
|
Unplanned repeat aortic intervention, n (%)
|
2 (0.4%)
|
1 (0.2%)
|
0.50 (0.05-5.54)
|
0.574
|
0.64 (0.06-7.27)
|
0.717
|
|
NYHA Class III or IV*, n (%)
|
63/478 (13.2%)
|
58/449 (12.9%)
|
0.98 (0.70-1.37)
|
0.906
|
0.97 (0.70-1.36)
|
0.879
|
|
At 5 years
|
|
All-cause mortality, n (%)
|
240 (43.8%)
|
300 (54.6%)
|
1.36 (1.15-1.61)
|
<0.001
|
1.27 (1.07-1.51)
|
0.007
|
|
Cardiovascular mortality, n (%)
|
167 (33.4%)
|
209 (42.7%)
|
1.36 (1.11-1.67)
|
0.003
|
1.28 (1.04-1.57)
|
0.021
|
|
Any stroke, n (%)
|
39 (7.9%)
|
45 (9.8%)
|
1.21 (0.79-1.86)
|
0.386
|
1.21 (0.78-1.88)
|
0.389
|
|
Major or life-threatening bleeding, n (%)
|
127 (23.6%)
|
187 (35.0%)
|
1.59 (1.27-1.99)
|
<0.001
|
1.51 (1.20-1.90)
|
<0.001
|
|
Structural valve deterioration, n (%)
|
18 (4.1%)
|
9 (2.3%)
|
0.53 (0.24-1.19)
|
0.123
|
0.53 (0.24-1.20)
|
0.129
|
|
Unplanned repeat aortic intervention, n (%)
|
2 (0.4%)
|
2 (0.4%)
|
1.02 (0.14-7.24)
|
0.985
|
1.29 (0.18-9.38)
|
0.802
|
|
NYHA Class III or IV*, n (%)
|
48/298 (16.1%)
|
32/237 (13.5%)
|
0.84 (0.55-1.27)
|
0.403
|
0.86 (0.57-1.30)
|
0.468
|
|
*Provided are number and percentage of patients with NYHA Class III or IV among patients assessed. Otherwise, provided are first events (cumulative incidence percent from life table estimate). Unplanned repeat aortic intervention includes valve-in-valve procedure, balloon valvuloplasty, surgical revision, or paravalvular leak closure in another setting. Adjustment was performed with age, gender, BMI, STS-PROM, NYHA Class III or IV.
|
