Table 2. Event rate (per 100 patient-years) and risk of study endpoints according to duration of heart failure (HF ≥2 months-1 year as reference).
| HF ≥2 months-1 year | HF >1-2 years | HF >2-5 years | HF >5 years | P-value for trend | |
|---|---|---|---|---|---|
| No. of patients | 1098 | 686 | 1105 | 1855 | |
| Worsening HF or cardiovascular death – no. (%) | 154 (14.0) | 101 (14.7) | 230 (20.8) | 403 (21.7) | <0.001 |
| Event rates per 100 patient-years (95% CI) | 10.2 (8.7-12.0) | 10.6 (8.7-12.9) | 15.5 (13.6-17.7) | 15.9 (14.5-17.6) | |
| Unadjusted* HR | 1.00 (ref) | 1.03 (0.80-1.33) | 1.56 (1.27-1.91) | 1.58 (1.32-1.91) | |
| Adjusted† HR | 1.00 (ref) | 0.98 (0.75-1.27) | 1.53 (1.23-1.90) | 1.60 (1.31-1.96) | |
| Hospitalization or urgent visit for HF - no. (%) | 84 (7.7) | 65 (9.5) | 138 (12.5) | 276 (14.9) | <0.001 |
| Event rates per 100 patient-years (95% CI) | 5.6 (4.5-6.9) | 6.8 (5.4-8.7) | 9.3 (7.9-11.0) | 10.9 (9.7-12.3) | |
| Unadjusted* HR | 1.00 (ref) | 1.22 (0.88-1.69) | 1.73 (1.32-2.27) | 2.01 (1.58-2.57) | |
| Adjusted† HR | 1.00 (ref) | 1.24 (0.88-1.74) | 1.76 (1.31-2.35) | 2.03 (1.55-2.65) | |
| HF hospitalization - no. (%) | 80 (7.3) | 65 (9.5) | 135 (12.2) | 269 (14.5) | <0.001 |
| Event rates per 100 patient-years (95% CI) | 5.3 (4.3-6.6) | 6.8 (5.4-8.7) | 9.1 (7.7-10.8) | 10.6 (9.4-12.0) | |
| Unadjusted* HR | 1.00 (ref) | 1.29 (0.93-1.78) | 1.78 (1.35-2.35) | 2.06 (1.60-2.64) | |
| Adjusted† HR | 1.00 (ref) | 1.31 (0.93-1.85) | 1.81 (1.35-2.43) | 2.08 (1.58-2.73) | |
| Urgent HF visit - no. (%) | 6 (0.5) | 2 (0.3) | 9 (0.8) | 16 (0.9) | 0.179 |
| Event rates per 100 patient-years (95% CI) | 0.4 (0.2-0.9) | 0.2 (0.1-0.8) | 0.6 (0.3-1.1) | 0.6 (0.4-1.0) | |
| Unadjusted* HR | 1.00 (ref) | 0.50 (0.10-2.50) | 1.52 (0.54-4.28) | 1.57 (0.61-4.01) | |
| Adjusted† HR | 1.00 (ref) | 0.56 (0.11-2.91) | 1.58 (0.50-4.97) | 1.77 (0.61-5.14) | |
| Cardiovascular death - no. (%) | 90 (8.2) | 54 (7.9) | 129 (11.7) | 227 (12.2) | <0.001 |
| Event rates per 100 patient-years (95% CI) | 5.7 (4.7-7.0) | 5.4 (4.2-7.1) | 8.2 (6.9-9.7) | 8.4 (7.4-9.6) | |
| Unadjusted* HR | 1.00 (ref) | 0.94 (0.67-1.31) | 1.44 (1.10-1.89) | 1.47 (1.15-1.87) | |
| Adjusted† HR | 1.00 (ref) | 0.85 (0.59-1.21) | 1.36 (1.02-1.81) | 1.46 (1.12-1.90) | |
| Cardiovascular death or HF hospitalization - no. (%) | 151 (13.8) | 101 (14.7) | 229 (20.7) | 396 (21.3) | <0.001 |
| Event rates per 100 patient-years (95% CI) | 10.0 (8.5-11.7) | 10.6 (8.7-12.9) | 15.4 (13.6-17.6) | 15.6 (14.1-17.2) | |
| Unadjusted* HR | 1.00 (ref) | 1.05 (0.82-1.36) | 1.58 (1.29-1.94) | 1.58 (1.31-1.91) | |
| Adjusted† HR | 1.00 (ref) | 1.00 (0.77-1.31) | 1.55 (1.25-1.94) | 1.60 (1.31-1.97) | |
| Total number of HF hospitalizations and Cardiovascular deaths - total events | 211 | 148 | 325 | 625 | |
| Event rates per 100 patient-years (95% CI) | 13.5 (11.3-16.2) | 14.9 (11.9-18.9) | 20.7 (18.0-23.9) | 23.3 (20.9-26.1) | |
| Unadjusted* HR | 1.00 (ref) | 1.10 (0.82-1.47) | 1.58 (1.26-1.98) | 1.75 (1.42-2.16) | |
| Adjusted† HR | 1.00 (ref) | 1.07 (0.78-1.46) | 1.52 (1.19-1.95) | 1.70 (1.35-2.14) | |
| All-cause mortality (no. of events) - no. (%) | 110 (10.0) | 63 (9.2) | 160 (14.5) | 272 (14.7) | <0.001 |
| Event rates per 100 patient-years (95% CI) | 7.0 (5.8-8.4) | 6.3 (4.9-8.1) | 10.1 (8.7-11.8) | 10.1 (9.0-11.4) | |
| Unadjusted* HR | 1.00 (ref) | 0.89 (0.65-1.22) | 1.46 (1.14-1.86) | 1.43 (1.15-1.79) | |
| Adjusted† HR | 1.00 (ref) | 0.81 (0.59-1.12) | 1.36 (1.05-1.76) | 1.40 (1.10-1.78) | |
| Change in KCCQ-TSS at 8 mo§ (±SE) | |||||
| Unadjusted|| | 6.48±0.53 | 5.46±0.67 | 4.70±0.54 | 3.07±0.41 | |
| Adjusted# | 6.17±0.53 | 5.27±0.67 | 4.76±0.54 | 3.35±0.41 | |
| Significant worsening in KCCQ-TSS (≥5) at 8 months§ | |||||
| Unadjusted** OR | 1.00 (ref) | 0.89 (0.77-1.03) | 1.07 (0.94-1.20) | 1.15 (1.05-1.28) | |
| Adjusted*** OR | 1.00 (ref) | 0.89 (0.77-1.03) | 1.06 (0.94-1.20) | 1.14 (1.02-1.27) | |
| Significant improvement in KCCQ-TSS (≥5) at 8 months§ | |||||
| Unadjusted** OR | 1.00 (ref) | 1.04 (0.91-1.18) | 0.99 (0.88-1.10) | 0.85 (0.78-0.94) | |
| Adjusted*** OR | 1.00 (ref) | 1.04 (0.91-1.18) | 0.99 (0.89-1.11) | 0.87 (0.79-0.96) |
Model adjusted for randomized therapy, previous heart failure hospitalization and stratified by diabetes status.
Model adjusted for model * and for age, sex, race, region, heart rate, systolic blood pressure, body mass index, New York Heart Association classification, left ventricular ejection fraction, baseline KCCQ clinical summary score, estimated glomerular filtration rate, history of myocardial infarction, atrial fibrillation, and log NT-proB-type Natriuretic Peptide (NT-proBNP).
RR denotes rate ratios with 95% confidence intervals (CI) within (), assessed using the LWYY model.
Scores on the Kansas City Cardiomyopathy Questionnaire (KCCQ) range from 0 to 100 (higher scores indicating fewer symptoms and physical limitations associated with heart failure).
Model adjusted for baseline KCCQ-TSS score and randomized treatment.
Model adjusted for model || and for age, sex, race, region, heart rate, systolic blood pressure, body mass index, New York Heart Association classification, left ventricular ejection fraction, baseline KCCQ clinical summary score, estimated glomerular filtration rate, history of myocardial infarction, atrial fibrillation, and log NT-proBNP.
Model adjusted for baseline KCCQ-TSS score rank, diabetes status and randomized treatment.
Model adjusted for model ** and for age, sex, race, region, heart rate, systolic blood pressure, body mass index, New York Heart Association classification, left ventricular ejection fraction, baseline KCCQ clinical summary score, estimated glomerular filtration rate, history of myocardial infarction, atrial fibrillation, and log NT-proBNP.