|
Table 1: Statistical by intention-to-treat analytical approach regarding the primary composite endpoint for safety. |
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|
Parameter |
TEER (1-year, %) |
MV Surgery (1-year, %) |
Difference (%) |
p* |
|
Death for any cause |
8.3 |
10.3 |
2.0 |
0.620 |
|
Rehospitalization for any cause |
24.7 |
39.0 |
14.3 |
0.027 |
|
Rehospitalization for HF |
3.4 |
8.5 |
5.1 |
0.120 |
|
CV Rehospitalization |
8.0 |
14.6 |
6.6 |
0.133 |
|
Reintervention |
7.6 |
18.5 |
10.9 |
0.019 |
|
Stroke |
1.1 |
4.8 |
3.7 |
0.115 |
|
VARC major bleeding |
3.3 |
29.8 |
26.5 |
< 0.0001 |
|
Deep wound infection |
1.1 |
4.9 |
3.8 |
0.109 |
|
AKF |
4.3 |
10.7 |
6.4 |
0.080 |
|
New onset AF |
8.7 |
33.3 |
24.6 |
< 0.0001 |
|
Intubation > 48 hours |
4.3 |
11.8 |
7.5 |
0.047 |
|
Sepsis |
1.1 |
4.8 |
3.7 |
0.115 |
|
Endocarditis |
0.0 |
1.2 |
1.2 |
0.263 |
|
AF = atrial fibrillation. AKF = acute kidney failure. CV = cardiovascular. HF = heart failure. MV = mitral valve. TEER = transcatheter edge-to-edge repair. VARC = valvular academic research consortium. * p values are considered as statistically highly significant as < 0.001. |
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