Table 1.
Baseline characteristics of the patients treated with ACURATE neo and of the entire population and the matched population treated with PORTICO.
| Entire Population | Matched Population (1:1) | ||||
|---|---|---|---|---|---|
| PORTICO | ACURATE Neo | p-Value | ACURATE Neo | p-Value | |
| (n = 344) | (n = 1247) | (n = 344) | |||
| Clinical characteristics | |||||
| Age | 83.0 (79.7–86.0) | 82.0 (78.6–85.0) | 0.003 | 82.8 (79.6–86.0) | 0.863 |
| Gender (male): | 138 (40.1%) | 484 (38.8%) | 0.707 | 149 (43.3%) | 0.439 |
| BMI (kg/m2) | 26.7 (24.2–30.7) | 26.6 (23.9–30.4) | 0.533 | 26.9 (24.0–30.9) | 0.905 |
| Log Euroscore (%) | 17.4 (11.2–26.8) | 17.5 (11.2–26.4) | 0.841 | 17.4 (11.6–26.8) | 0.911 |
| Euroscore II (%) | 4.2 (2.7–7.0) | 4.1 (2.6–6.8) | 0.344 | 4.2 (2.6–7.2) | 0.731 |
| NYHA (III/IV) | 290 (84.3%) | 1008 (80.8%) | 0.164 | 298 (86.6%) | 0.449 |
| COPD | 70 (20.3%) | 241 (19.3%) | 0.729 | 72 (20.9%) | 0.925 |
| Hypertension | 308 (89.5%) | 1121 (89.9%) | 0.924 | 313 (91.0%) | 0.607 |
| Diabetes | 120 (34.9%) | 400 (32.1%) | 0.359 | 130 (37.8%) | 0.476 |
| eGFR (mL/min) | 54.0 (41.8–74.2) | 59.0 (43.0–78.0) | 0.059 | 59.0 (42.0–76.2) | 0.423 |
| Creatinine (mg/dL) | 1.0 (0.8–1.3) | 1.0 (0.8–1.3) | 0.346 | 1.0 (0.8–1.3) | 0.971 |
| Dialysis | 6 (1.7%) | 32 (2.6%) | 0.494 | 4 (1.2%) | 0.750 |
| PAD | 48 (14.0%) | 173 (13.9%) | 1.000 | 45 (13.1%) | 0.824 |
| Previous Stroke | 31 (9.0%) | 168 (13.5%) | 0.034 | 27 (7.8%) | 0.681 |
| CAD | 230 (66.9%) | 821 (65.8%) | 0.772 | 227 (66.0%) | 0.872 |
| Previous MI | 37 (10.8%) | 142 (11.4%) | 0.817 | 33 (9.6%) | 0.705 |
| Previous PCI | 129 (37.5%) | 471 (37.8%) | 0.977 | 124 (36.0%) | 0.752 |
| Previous CABG | 31 (9.0%) | 125 (10.0%) | 0.648 | 31 (9.0%) | 1.000 |
| Echocardiographic characteristics | |||||
| LVEF (%) | 60.0 (52.0–65.0) | 62.0 (53.0–65.0) | 0.057 | 60.0 (50.0–65.0) | 0.474 |
| Pmean (mmHg) | 43.0 (35.0–50.0) | 41.0 (31.0–49.0) | 0.006 | 41.0 (32.0–51.0) | 0.405 |
| MR (≥Grade II) | 5 (1.5%) | 11 (0.9%) | 0.361 | 5 (1.5%) | 1.000 |
| TR (≥Grade II) | 5 (1.5%) | 17 (1.4%) | 0.800 | 4 (1.2%) | 1.000 |
| sPAP (≥60 mmHg) | 25 (8.9%) | 94 (9.0%) | 1.000 | 32 (9.3%) | 1.000 |
| Electrocardiographic characteristics | |||||
| Atrial fibrillation | 135 (39.2%) | 479 (38.4%) | 0.827 | 129 (37.5%) | 0.695 |
| LBBB | 34 (10.0%) | 109 (8.8%) | 0.568 | 36 (10.5%) | 0.900 |
| RBBB | 17 (5.0%) | 133 (10.7%) | 0.002 | 14 (4.1%) | 0.713 |
| Pacemaker | 66 (19.2%) | 147 (11.8%) | 0.001 | 49 (14.2%) | 0.102 |
| MSCT data | |||||
| Prosthesis area (cm2) | 4.3 (4.0–4.9) | 4.5 (4.0–4.9) | 0.435 | 4.6 (4.1–4.9) | 0.064 |
| Minimum diameter (mm) | 20.7 (19.2–22.0) | 20.3 (19.0–21.8) | 0.007 | 20.9 (19.6–22.0) | 0.197 |
| Maximum diameter (mm) | 26.9 (25.4–28.2) | 26.7 (25.1–28.0) | 0.131 | 27.0 (25.7–28.4) | 0.431 |
| Distance to LCA (mm) | 13.0 (11.6–15.0) | 13.1 (11.1–15.2) | 0.966 | 13.1 (11.9–15.4) | 0.321 |
| Distance to RCA (mm) | 17.0 (15.0–19.0) | 17.0 (15.0–19.0) | 0.422 | 17.1 (15.4–19.0) | 0.040 |
| Eccentricity | 0.2 (0.2–0.3) | 0.2 (0.2–0.3) | 0.057 | 0.2 (0.2–0.3) | 0.630 |
| Calcification (AU) | 2366.0 (1661.0–3371.0) | 2197.5 (1400.5–3187.2) | 0.015 | 2512.0 (1641.0–3435.0) | 0.743 |
Values are the mean ± SD, n (%) or median (interquartile range). CABG = coronary artery bypass grafting; COPD = chronic obstructive pulmonary disease; CAD = coronary artery disease; MI = myocardial infarction; PAD = peripheral artery disease; eGFR = creatinine clearance; LBBB = complete left bundle branch block; LV = left ventricular; EF = Ejection fraction; MR = Mitral Regurgitation, TR = tricuspid regurgitation, sPAP = systolic pulmonary arterial pressure; MSCT = multislice computed tomography; NYHA = New York Heart Association functional class; PCI = percutaneous coronary intervention; RBBB = complete right bundle branch block, AU = Angaston units.