Table 1.
Baseline Patient Characteristics.
| Characteristic | All Patients (n = 359) | SAPIEN 3 (n = 215) | Evolut R (n = 144) | p-Value |
|---|---|---|---|---|
| Age (Years) | 81.9 ± 6.6 | 81.7 ± 6.6 | 82.2 ± 6.7 | 0.469 |
| Male Sex-n (%) | 167 (46.5) | 118 (54.9) | 49 (34) | <0.001 |
| BMI (kg/m2) | 27.1 ± 5.4 | 27.2 ± 5.2 | 27 ± 5.8 | 0.773 |
| EuroSCORE II | 8.0 ± 8.1 | 8.2 ± 8.2 | 7.8 ± 8.1 | 0.621 |
| STS Score PROM | 7.3 ± 8.9 | 7.3 ± 6.8 | 7.4 ± 5.0 | 0.092 |
| NYHA Class ≥ III-n (%) | 259 (72.1) | 149 (69.3) | 110 (76.4) | 0.142 |
| Coronary Artery Disease-n (%) | 224 (62.4) | 137 (63.7) | 87 (60.4) | 0.526 |
| Previous Myocardial Infarction-n (%) | 62 (17.3) | 44 (20.5) | 18 (12.5) | 0.05 |
| Previous PCI-n (%) | 140 (39) | 89 (41.4) | 51 (35.4) | 0.255 |
| Previous CABG-n (%) | 45 (12.5) | 28 (13.0) | 17 (11.8) | 0.733 |
| Previous Stroke or TIA-n (%) | 60 (16.7) | 42 (19.5) | 18 (12.5) | 0.08 |
| Peripheral Art. Disease ≥ Grade II | 33 (9.2) | 17 (7.9) | 16 (11.1) | 0.303 |
| Art. Hypertension-n (%) | 314 (87.5) | 196 (91.6) | 118 (81.9) | 0.006 |
| Diabetes (%) | 114 (31.7) | 59 (27.9) | 55 (38.2) | 0.041 |
| COPD ≥ Grade II (GOLD)-n (%) | 37 (10.3) | 23 (10.7) | 14 (9.7) | 0.766 |
| GFR < 30 mL/min | 62 (17.3) | 34 (15.8) | 28 (19.4) | 0.372 |
| History of Cancer | 45 (12.5) | 26 (12.1) | 19 (13.2) | 0.757 |
| Atrial Fibrillation-n (%) | 87 (24.2) | 55 (25.9) | 32 (22.4) | 0.66 |
| Permanent Pacemaker/ICD-n (%) | 41 (11.4) | 25 (11.6) | 16 (11.1) | 0.88 |
| Pulm. Hypertension-n (%) | 80 (22.3) | 40 (18.6) | 40 (27.8) | 0.041 |
| Left Ventricular Ejection Fraction (%) | 51.5 ± 13.5 | 49.6 ± 14.4 | 54.5 ± 11.3 | <0.001 |
| Aortic Valve Area (cm2) | 0.74 ± 0.2 | 0.80 ± 0.2 | 0.71 ± 0.2 | 0.017 |
| Aortic Valve Peak Gradient (mmHg) | 68.4 ± 25.7 | 67.5 ± 25.5 | 69.9 ± 26 | 0.367 |
| Aortic Valve Mean Gradient (mmHg) | 40.4 ± 16.8 | 39.9 ± 16.4 | 41.2 ± 17.2 | 0.493 |
| Commissural Calcification (mean) | 1.80 ± 0.7 | 1.80 ± 0.8 | 1.81 ± 0.7 | 0.941 |
| Annular/LVOT Calcification (mean) | 0.77 ± 0.9 | 0.70 ± 0.9 | 0.88 ± 1.0 | 0.077 |
BMI = Body Mass Index, EuroSCORE = European System for Cardiac Operative Risk Evaluation, STS = Society of Thoracic Surgeons, PROM = predicted risk of mortality, NYHA class = New York Heart Association Functional Classification of Heart Failure, PCI = Percutaneous Coronary Intervention, CABG = Coronary Artery Bypass Graft, TIA = Transient Ischemic Attack, COPD = Chronic Obstructive Pulmonary Disease, GFR = Glomerular filtration rate, ICD = Internal Cardioverter Defibrillator.