Edwards SAPIEN 3 - Key Adverse Events

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Table 14:
Patient Demographics and Baseline Characteristics
(S3OUS AT Population)
Demographics and Baseline
Characteristics
SAPIEN 3
Valve
Overall
(N = 102)
SAPIEN 3 Valve
Transfemoral
Access
(N = 57)
SAPIEN 3 Valve
Non-Transfemoral
Access
(N = 45)
Coronary-artery bypass grafting
(CABG)
24 (23.5%)
10 (17.5%)
14 (31.1%)
Percutaneous coronary intervention
(PCI)
34 (33.3%)
16 (28.1%)
18 (40.0%)
Prior aortic valvuloplasty
10 (9.8%)
8 (14.0%)
2 (4.4%)
Stroke, no.(%)
7 (6.9%)
4 (7.0%)
3 (6.7%)
Peripheral vascular disease, no.(%)
27 (26.5%)
10 (17.5%)
17 (37.8%)
Chronic obstructive pulmonary disease
(COPD), no.(%):
Any
25 (24.5%)
13 (22.8%)
12 (26.7%)
Oxygen-dependent
1 (1.0%)
1 (1.8%)
0 (0%)
Atrial fibrillation, no.(%)
48 (47.1%)
22 (38.6%)
26 (57.8%)
Permanent pacemaker, no.(%)
15 (14.7%)
7 (12.3%)
8 (17.8%)
Severe pulmonary hypertension, no.(%)
10 (9.8%)
6 (10.5%)
4 (8.9%)
Severe liver disease / Cirrhosis, no.(%)
1 (1.0%)
1 (1.8%)
0 (0%)
Echocardiographic findings
Effective Orifice Area (EOA), cm
2
0.6 ± 0.2
0.6 ± 0.2
0.6 ± 0.1
Mean aortic-valve gradient, mmHg
44.8 ± 15.3
45.2 ± 14.7
44.2 ± 16.1
Mean left ventricular ejection
fraction (LVEF), %
56.7 ± 9.1
57.7 ± 9.3
55.3 ± 8.7
Moderate or severe mitral
regurgitation, no./total no. (%)
23/85
(27.1%)
9/48
(18.8%)
14/37
(37.8%)
Plus–minus values are means ± SD.
Safety and Effectiveness Results
Key Adverse Events
Key adverse events as adjudicated by the CEC are presented in Table 15.
Table 15:
CEC Adjudicated Adverse Events at 1 Year
(S3OUS AT Population)
30 Day 1 Year
Outcomes
SAPIEN 3
Valve
Overall
SAPIEN 3
Valve
Transfemoral
Access
SAPIEN 3
Valve
Non-
Transfemoral
Access
SAPIEN 3
Valve
Overall
SAPIEN 3
Valve
Transfemoral
Access
SAPIEN 3 Valve
Non-
Transfemoral
Access
Composite Event
Rate of Death, All
Stroke and AI ≥
Moderate,
n/N (%)
13/88
(14.8%)
3/50
(6.0%)
10/38
(26.3%)
25/82
(30.5%)
9/47
(19.1%)
16/35
(45.7%)
Death