Table 3.
Clinical Outcomes
| No. of Patients With Events (Cumulative 5‐Year Incidence) | Log‐Rank P Value | Unadjusted HR (95% CI) | P Value | Adjusted HR (95% CI) | P Value | |
|---|---|---|---|---|---|---|
| Primary outcome measure | ||||||
| Composite of aortic valve–related death or hospitalization due to HF | <0.001 | |||||
| Group 1 (AVA >0.8 cm2) | 124 (24.1%) | Reference | Reference | |||
| Group 2 (0.8 cm2 ≥AVA >0.6 cm2) | 106 (29.1%) | 1.26 (0.98–1.64) | 0.08 | 1.34 (1.01–1.78) | 0.04 | |
| Group 3 (AVA ≤0.6 cm2) | 67 (48.1%) | 2.22 (1.65–2.98) | <0.001 | 2.21 (1.56–3.11) | <0.001 | |
| Secondary outcome measures | ||||||
| All‐cause death | <0.001 | |||||
| Group 1 (AVA >0.8 cm2) | 160 (27.4%) | Reference | Reference | |||
| Group 2 (0.8 cm2 ≥AVA >0.6 cm2) | 160 (40.0%) | 1.47 (1.18–1.83) | <0.001 | 1.49 (1.17–1.89) | 0.001 | |
| Group 3 (AVA ≤0.6 cm2) | 94 (59.5%) | 2.28 (1.77–2.94) | <0.001 | 2.61 (1.96–3.47) | <0.001 | |
| Cardiovascular death | <0.001 | |||||
| Group 1 (AVA >0.8 cm2) | 91 (16.9%) | Reference | Reference | |||
| Group 2 (0.8 cm2 ≥AVA >0.6 cm2) | 85 (24.2%) | 1.38 (1.02–1.85) | 0.03 | 1.48 (1.07–2.05) | 0.02 | |
| Group 3 (AVA ≤0.6 cm2) | 66 (47.9%) | 2.83 (2.06–3.88) | <0.001 | 3.36 (2.34–4.83) | <0.001 | |
| Aortic valve–related death | <0.001 | |||||
| Group 1 (AVA >0.8 cm2) | 46 (10.0%) | Reference | Reference | |||
| Group 2 (0.8 cm2 ≥AVA >0.6 cm2) | 56 (16.3%) | 1.80 (1.22–2.66) | 0.003 | 2.01 (1.31–3.08) | 0.001 | |
| Group 3 (AVA ≤0.6 cm2) | 42 (34.1%) | 3.60 (2.37–5.47) | <0.001 | 4.53 (2.79–7.34) | <0.001 | |
| Aortic valve procedure death | 0.01 | |||||
| Group 1 (AVA >0.8 cm2) | 6 (1.3%) | Reference | ||||
| Group 2 (0.8 cm2 ≥AVA >0.6 cm2) | 3 (1.1%) | 0.73 (0.18–2.91) | 0.65 | N/A | ||
| Group 3 (AVA ≤0.6 cm2) | 6 (4.7%) | 3.72 (1.20–11.5) | 0.02 | N/A | ||
| Sudden death | 0.08 | |||||
| Group 1 (AVA >0.8 cm2) | 26 (5.8%) | Reference | ||||
| Group 2 (0.8 cm2 ≥AVA >0.6 cm2) | 22 (5.2%) | 1.23 (0.70–2.17) | 0.47 | N/A | ||
| Group 3 (AVA ≤0.6 cm2) | 14 (14.8%) | 2.12 (1.11–4.07) | 0.02 | N/A | ||
| Emerging symptoms related to AS | <0.001 | |||||
| Group 1 (AVA >0.8 cm2) | 186 (18.5%) | Reference | Reference | |||
| Group 2 (0.8 cm2 ≥AVA >0.6 cm2) | 151 (44.1%) | 1.20 (0.97–1.49) | 0.09 | 1.27 (1.01–1.56) | 0.045 | |
| Group 3 (AVA ≤0.6 cm2) | 77 (63.0%) | 1.77 (1.36–2.31) | <0.001 | 1.82 (1.35–2.45) | <0.001 | |
| HF hospitalization | <0.001 | |||||
| Group 1 (AVA >0.8 cm2) | 97 (19.3%) | Reference | Reference | |||
| Group 2 (0.8 cm2 ≥AVA >0.6 cm2) | 83 (23.9%) | 1.27 (0.95–1.70) | 0.11 | 1.33 (0.96–1.83) | 0.08 | |
| Group 3 (AVA ≤0.6 cm2) | 50 (37.7%) | 2.14 (1.52–3.01) | <0.001 | 1.95 (1.31–2.92) | 0.001 | |
| AVR | 0.43 | |||||
| Group 1 (AVA >0.8 cm2) | 178 (39.7%) | Reference | ||||
| Group 2 (0.8 cm2 ≥AVA >0.6 cm2) | 125 (43.7%) | 1.08 (0.86–1.35) | 0.53 | N/A | ||
| Group 3 (AVA ≤0.6 cm2) | 50 (39.9%) | 1.23 (0.90–1.68) | 0.20 | N/A | ||
The number of patients with at least 1 event was counted through the entire follow‐up period, while cumulative incidence was estimated at 5 years. Aortic valve–related death included aortic procedure–related death, sudden death, and death due to HF. HF hospitalization was defined as hospitalization due to worsening HF requiring intravenous drug therapy. Risk‐adjusting variables: age, sex, body mass index, hypertension, current smoking, diabetes mellitus on insulin, coronary artery disease, prior myocardial infarction, prior symptomatic stroke, atrial fibrillation or flutter, aorta/peripheral artery disease, serum creatinine, hemodialysis, anemia, liver cirrhosis, malignancy currently under treatment, chronic lung disease, any valvular disease, LVEF ≥68% and TR pressure gradient ≥40 mm Hg. AS indicates aortic stenosis; AVA, aortic valve area; AVR, aortic valve replacement; HF, heart failure; HR, hazard ratio; LVEF, left ventricular ejection fraction; N/A, not assessed; TR, tricuspid regurgitation.