Table 1. Characteristics of the Participants at Baselinea.
| Characteristic | TAVI (n = 458) | Surgery (n = 455) |
|---|---|---|
| Age, median (IQR), y | 81 (79-84) | 81 (78-84) |
| Age group, No. (%) | ||
| 70-79 | 143 (31.2) | 143 (31.4) |
| ≥80 | 315 (68.8) | 312 (68.6) |
| Sex, No. (%) | ||
| Male | 247 (53.9) | 242 (53.2) |
| Female | 211 (46.1) | 213 (46.8) |
| Ethnicity, No. (%)b | ||
| Asian or Asian British | 5 (1.1) | 6 (1.3) |
| Black, African, Caribbean, or Black British | 0 | 6 (1.3) |
| Mixed or multiple ethnic groups | 1 (0.2) | 1 (0.2) |
| White | 447 (97.6) | 434 (95.4) |
| Other | 5 (1.1)c | 8 (1.8)d |
| Body mass index, median (IQR)e | (n = 458); 27.1 (24.0-30.5) | (n = 452); 27.7 (24.7-31.2) |
| Society of Thoracic Surgeons mortality risk score, median (IQR), %f | (n = 458) | (n = 454) |
| Overall | 2.6 (2.0-3.5) | 2.7 (2.0-3.4) |
| By age group, y | ||
| 70-79 | 2.1 (1.6-2.8) | 2.0 (1.6-2.8) |
| ≥80 | 2.9 (2.2-3.7) | 2.9 (2.3-3.8) |
| EuroSCORE II risk score, median (IQR), %g | (n = 458) | (n = 454) |
| Overall | 2.0 (1.4-3.0) | 2.0 (1.5-3.3) |
| By age group, y | ||
| 70-79 | 1.7 (1.3-2.6) | 1.8 (1.3-2.8) |
| ≥80 | 2.2 (1.5-3.2) | 2.3 (1.6-3.4) |
| New York Heart Association class III or IV, No./total (%)h | 184/457 (40.3) | 204/451 (45.2) |
| Frailty, No./total (%) | ||
| CSHA Clinical Frailty Scale score ≥5i | 58/454 (12.8) | 60/449 (13.4) |
| Fried classificationj | ||
| Prefrail | 221/433 (51.0) | 204/417 (48.9) |
| Frail | 122/433 (28.2) | 124/417 (29.7) |
| Coronary artery disease, No./total (%)k | 133/444 (30.0) | 145/435 (33.3) |
| Echocardiographic parametersl | ||
| Aortic valve area, median (IQR), cm2 | (n = 442); 0.7 (0.6-0.9) | (n = 434); 0.7 (0.6-0.8) |
| Aortic valve peak gradient, median (IQR), mm Hg | (n = 453); 73 (59-89) | (n = 445); 74 (60-88) |
| Left ventricular ejection fraction, median (IQR), % | (n = 438); 57 (55-64) | (n = 437); 57 (55-64) |
| Moderate or severe aortic regurgitation, No./total (%) | 47/441 (10.7) | 58/436 (13.3) |
Abbreviations: CSHA, Canadian Study of Health and Aging; EuroSCORE, European System for Cardiac Operative Risk Evaluation; TAVI, transcatheter aortic valve implantation.
Additional clinical details and medical history appear in eTable 1 in Supplement 2.
Recorded to assess the diversity of the study population, which may have implications for the external validity of the trial in different ethnic groups, and was determined by the site staff based on discussion with the participant or review of hospital records using a list of prespecified options corresponding to those used by the UK Office for National Statistics.
Specified as Italian for 2 participants and for 1 participant each as Arab, Maltese, and Polish.
Specified for 1 participant each as Arab, French, German, Greek Armenian, Greek Cypriot, Polish, and White Italian. No further details were reported for 1 participant.
Calculated as weight in kilograms divided by height in meters squared.
Provides an estimate of the predicted 30-day mortality among patients undergoing surgical aortic valve replacement on the basis of a number of demographic and procedural variables.9,10
A risk model for estimating the predicted in-hospital mortality after cardiac surgery. The score is based on a combination of patient-, cardiac-, and operation-related factors. A higher score denotes a higher operative risk.11,12
Determined by site staff during the baseline clinical assessment and is a functional classification based on the extent to which the patient is limited by their symptoms (class I, no limitation of physical activity; class II, slight limitation of ordinary physical activity; class III, marked limitation of ordinary physical activity; class IV, symptoms at rest or with minimal activity).18
Evaluates function to generate a frailty score and was determined by the interviewer during the clinical assessment. Scores range from 1 (very fit) to 7 (severely frail); a higher score indicates greater frailty and an increased risk of death and other adverse outcomes.14
Identifies a frailty phenotype based on 5 criteria: unintentional weight loss, self-reported exhaustion, weakness (based on grip strength), slow walking speed, and low physical activity level. Patients are classified as not frail (did not meet frailty criteria), prefrail (met 1 or 2 criteria), or frail (met ≥3 criteria). The frailty phenotype is independently predictive of incident falls, worsening mobility or disability, hospitalization, and death.13
Presence of greater than 50% diameter stenosis in 1 or more coronary arteries on angiogram.
Reported by each study site.