Table 1.
Baseline characteristics and health-related quality-of-life scores
| NRCA TA-TAVR (n=875) | RCT TA-TAVR (n=99) | p-value* | RCT SAVR (n=80) | p-value* | |
|---|---|---|---|---|---|
| Demographic and clinical characteristics | |||||
| Age (years) | 84.6 ± 6.3 | 82.6 ± 6.9 | <0.01 | 83.4 ± 5.5 | 0.02 |
| Male (%) | 47.1 | 51.5 | 0.40 | 58.8 | 0.05 |
| STS Score | 12.0 ± 4.2 | 11.8 ± 3.7 | 0.64 | 11.8 ± 3.1 | 0.70 |
| Previous MI (%) | 29.4 | 28.3 | 0.82 | 36.3 | 0.20 |
| Prior CABG (%) | 51.1 | 50.5 | 0.91 | 57.5 | 0.27 |
| Prior PCI (%) | 46.6 | 32.3 | <0.01 | 43.0 | 0.55 |
| Prior BAV (%) | 28.6 | 12.1 | <0.01 | 12.5 | <0.01 |
| LV ejection fraction (%) | 52.2 ± 12.6 | 53.1 ± 12.3 | 0.50 | 53.3 ± 10.8 | 0.44 |
| Cerebrovascular Disease (%) | 29.9 | 41.8 | 0.02 | 33.3 | 0.54 |
| Peripheral Vascular Disease (%) | 61.7 | 62.2 | 0.91 | 63.3 | 0.78 |
| Diabetes Mellitus (%) | 35.0 | 40.4 | 0.28 | 48.8 | 0.01 |
| Renal Disease (Cr ≥ 2 mg/dL)(%) | 16.7 | 13.1 | 0.36 | 22.5 | 0.19 |
| Liver Disease (%) | 2.7 | 2.0 | 0.67 | 0.0 | 0.13 |
| COPD (Oxygen dependent) (%) | 8.7 | 12.1 | 0.26 | 8.8 | 0.98 |
| Major arrhythmia (%) | 48.5 | 53.5 | 0.34 | 47.5 | 0.86 |
| Permanent pacemaker (%) | 21.3 | 20.2 | 0.80 | 21.3 | 0.99 |
| Pulmonary hypertension (%) | 36.8 | 46.5 | 0.06 | 29.1 | 0.17 |
| Quality-of-life scores | |||||
| KCCQ Summary | 44.2 ± 21.5 | 40.6 ± 22.1 | 0.11 | 45.4 ± 19.7 | 0.64 |
| KCCQ Physical Limitation | 41.6 ± 24.5 | 41.2 ± 24.3 | 0.89 | 48.1 ± 23.4 | 0.03 |
| KCCQ Total Symptoms | 55.7 ± 22.8 | 49.6 ± 23.3 | 0.01 | 54.3 ± 21.6 | 0.61 |
| KCCQ Quality of Life | 40.2 ± 23.6 | 35.0 ± 26.6 | 0.04 | 39.7 ± 22.2 | 0.85 |
| KCCQ Social Limitation | 37.4 ± 28.2 | 35.3 ± 30.1 | 0.51 | 39.4 ± 26.9 | 0.54 |
| SF-12 Physical | 31.4 ± 8.1 | 29.4 ± 7.4 | 0.02 | 31.8 ± 8.6 | 0.69 |
| SF-12 Mental | 48.2 ± 11.2 | 46.8 ± 11.4 | 0.24 | 48.4 ± 9.6 | 0.86 |
| EQ-5D Utilities | 0.68 ± 0.19 | 0.67 ± 0.19 | 0.61 | 0.72 ± 0.17 | 0.12 |
*
p-values relate to the comparison with NRCA TA-TAVR
Values are mean ± SD or %.
BAV = balloon aortic valvuloplasty; CABG = coronary artery bypass grafting; COPD = chronic obstructive pulmonary disease; EQ-5D = EuroQol 5D; KCCQ = Kansas City Cardiomyopathy Questionnaire; LV = left ventricular; MI = myocardial infarction; NRCA = non-randomized continued access registry; PCI = percutaneous coronary intervention; SAVR = surgical aortic valve replacement; SF-12 = Medical Outcomes Study Short-Form 12; STS = Society of Thoracic Surgeons; TA = transapical; TAVR = transcatheter aortic valve replacement.