Table 2 Outcomes, variable type, time/period of measurement, and statistical analysis for primary and exploratory outcomes
Outcomea | Type of variable | Time or period of measurement | Statistical type of analysisb |
|---|---|---|---|
Myocardial infarction, stroke, or all-cause mortality (P) | Binary | During 12 months | 1 |
Myocardial infarction (E) | Binary | During 30 days. During 12 months | 1 |
Stroke (E) | Binary | During 30 days. During 12 months | 1 |
All-cause mortality (E) | Binary | During 30 days. During 12 months | 1 |
Cardiovascular mortality (E) | Binary | During 30 days. During 12 months | 1 |
Prosthesis re-intervention (E) | Binary | During 30 days. During 12 months | 1 |
Conduction abnormality requiring pacemaker (E) | Binary | During 30 days. During 12 months | 1 |
Arrhythmia (E) | Binary | During 30 days. During 12 months | 1 |
Endocarditis (E) | Binary | During 30 days. During 12 months | 1 |
Mechanical ventilation in ≥24 hours (E) | Binary | During 30 days | 1 |
Acute kidney injury (stage 2 or 3) (E) | Binary | During 30 days | 1 |
Access-site injury (major) (E) | Binary | During 30 days | 1 |
Bleeding (major–minor) (E) | Ordered | During 30 days | 3 |
Number of days hospitalised (E) | Discrete | During 12 months | 2 |
NYHA functional class (I to IV) (E) | Orderedc | At 3 months and at 12 months | 3 |
SF-36 Quality of life (E) | Continuousc | At 3 months and at 12 months | 4 |
Effective orifice area (E) | Continuousc | At 3 months and at 12 months | 4 |
Prosthesis peak gradient (E) | Continuousc | At 3 months and at 12 months | 4 |
Prosthesis mean gradient (E) | Continuousc | At 3 months and at 12 months | 4 |
Prosthesis regurgitation (E) | Orderedd | At 3 months and at 12 months | 3 |
Prosthesis–patient mismatch (severe) (E) | Binary | At 3 months and at 12 months | 1 |
Left ventricular ejection fraction (E) | Continuousc | At 3 months and at 12 months | 4 |