Edwards SAPIEN 3

31
Study Population Demographics and Baseline Parameters
The demographics of the PIIS3i and PIIA-SAVR EP populations are summarized in Table 17.
Table 17: Patient Demographics and Baseline Characteristics of the EP Population
Demographics &
Characteristics
SAPIEN 3 Valve
PIIA-SAVR
(N=938)
Overall
(N = 1074)
TF Only
(N = 948)
Non-TF Only
(N=126)
Age - years 81.9 ± 6.60 82.1 ± 6.57 80.7 ± 6.69 81.6±6.73
Male sex 662/1074
(61.6%)
577/948
(60.9%)
85/126
(67.5%)
514/938
(54.8%)
Society of Thoracic
Surgeons (STS) score
5.3 ± 1.29 5.3 ± 1.29 5.6 ± 1.28 5.8±1.92
New York Heart Association (NYHA) class
I/II 294/1074
(27.4%)
262/948
(27.6%)
32/126
(25.4%)
225/937
(24.0%)
III/IV 780/1074
(72.6%)
686/948
(72.4%)
94/126
(74.6%)
712/937
(76.0%)
Coronary artery disease 748/1074
(69.6%)
652/948
(68.8%)
96/126
(76.2%)
623/938
(66.4%)
Previous myocardial
infarction
172/1074
(16.0%)
133/948
(14.0%)
39/126
(31.0%)
166/938
(17.7%)
Previous intervention
Coronary artery
bypass grafting
(CABG)
301/1074
(28.0%)
248/948
(26.2%)
53/126
(42.1%)
241/938
(25.7%)
Percutaneous
coronary intervention
(PCI)
344/1074
(32.0%)
299/948
(31.5%)
45/126
(35.7%)
254/938
(27.1%)
Prior aortic
valvuloplasty
55/1074
(5.1%)
51/948
(5.4%)
4/126 (3.2%)
45/938
(4.8%)
Cerebral vascular accident
(CVA)
97/1074
(9.0%)
81/948
(8.5%)
16/126
(12.7%)
96/938
(10.2%)
Peripheral vascular
disease
304/1074
(28.3%)
231/948
(24.4%)
73/126
(57.9%)
301/938
(32.1%)
Chronic obstructive pulmonary disease (COPD)
Any 321/1072
(29.9%)
270/946
(28.5%)
51/126
(40.5%)
279/932
(29.9%)
Oxygen-dependent 53/1067
(5.0%)
46/942
(4.9%)
7/125 (5.6%)
26/925
(2.8%)
Atrial fibrillation 385/1074
(35.8%)
342/948
(36.1%)
43/126
(34.1%)
326/938
(34.8%)
Permanent pacemaker 142/1074
(13.2%)
121/948
(12.8%)
21/126
(16.7%)
113/938
(12.0%)
Severe pulmonary
hypertension
25/1074
(2.3%)
19/948
(2.0%)
6/126 (4.8%)
N/A
Frailty 92/1074
(8.6%)
86/948
(9.1%)
6/126 (4.8%)
15/938
(1.6%)