Table 2.
Clinical outcomes according to chronic obstructive pulmonary disease status
| Without COPD(n = 4159) | With COPD(n = 585) | |
|---|---|---|
| Primary outcome | ||
| Events, n (%) | 744 (17.9) | 144 (24.6) |
| Event rate/100 person‐ years | 13.0 (12.1–14.0) | 18.9 (16.0–22.2) |
| HR | 1.00 (ref.) |
1.44 (1.21–1.72) <0.001 |
| HR‐1 | 1.00 (ref.) |
1.26 (1.05–1.52) 0.014 |
| HR‐2 | 1.00 (ref.) |
1.24 (1.03–1.50) 0.023 |
| Worsening HF event | ||
| Events, n (%) | 456 (11.0) | 107 (18.3) |
| Event rate/100 person‐years | 8.0 (7.3–8.8) | 14.0 (11.6–17.0) |
| HR | 1.00 (ref.) |
1.74 (1.41–2.15) <0.001 |
| HR‐1 | 1.00 (ref.) |
1.53 (1.22–1.90) <0.001 |
| HR‐2 | 1.00 (ref.) |
1.51 (1.21–1.89) <0.001 |
| First HF hospitalization | ||
| Events, n (%) | 443 (10.7) | 106 (18.1) |
| Event rate/100 person‐years | 7.7 (7.1–8.5) | 13.9 (11.5–16.8) |
| HR | 1.00 (ref.) |
1.78 (1.44–2.20) <0.001 |
| HR‐1 | 1.00 (ref.) |
1.58 (1.26–1.97) <0.001 |
| HR‐2 | 1.00 (ref.) |
1.57 (1.25–1.96) <0.001 |
| Urgent visit for HF | ||
| Events, n (%) | 30 (0.7) | 3 (0.5) |
| Event rate/100 person‐years | 0.5 (0.4–0.7) | 0.4 (0.1–1.1) |
| HR | 1.00(ref.) |
0.75 (0.23–2.45) 0.629 |
| HR‐1 | 1.00 (ref.) |
0.63 (0.19–2.12) 0.453 |
| HR‐2 | 1.00 (ref.) |
0.54 (0.16–1.86) 0.332 |
| CV death | ||
| Events, n (%) | 424 (10.2) | 76 (13.0) |
| Event rate/100 person‐years | 7.1 (6.4–7.8) | 9.1 (7.2–11.4) |
| HR | 1.00 (ref.) |
1.28 (1.00–1.63) 0.049 |
| HR‐1 | 1.00 (ref.) |
1.10 (0.85–1.42) 0.453 |
| HR‐2 | 1.00 (ref.) |
1.08 (0.84–1.39) 0.553 |
| Total HF hospitalization/CV death | ||
| Events, n | 1070 | 239 |
| Event rate/100 person‐years | 17.9 (16.8–19.0) | 28.8 (25.3–32.7) |
| RR | 1.00 (ref.) |
1.59 (1.31–1.93) <0.001 |
| RR‐1 | 1.00 (ref.) |
1.40 (1.15–1.72) 0.001 |
| RR‐2 | 1.00 (ref.) |
1.39 (1.14–1.70) 0.001 |
| Non‐CV death | ||
| Events, n (%) | 74 (1.8) | 31 (5.3) |
| Event rate/100 person‐years | 1.2 (1.0–1.5) | 3.7 (2.6–5.2) |
| HR | 1.00 (ref.) |
2.99 (1.97–4.56) <0.001 |
| HR‐1 | 1.00 (ref.) |
2.18 (1.38–3.42) 0.001 |
| HR‐2 | 1.00 (ref.) |
2.23 (1.42–3.51) 0.001 |
| All‐cause death | ||
| Events, n (%) | 498 (12.0) | 107 (18.3) |
| Event rate/100 person‐years | 8.3 (7.6–9.1) | 12.7 (10.5–15.4) |
| HR | 1.00 (ref.) |
1.53 (1.25–1.89) <0.001 |
| HR‐1 | 1.00 (ref.) |
1.27 (1.02–1.58) 0.031 |
| HR‐2 | 1.00 (ref.) |
1.26 (1.01–1.57) 0.041 |
| KCCQ total symptom score (change assessed at 8 months) | ||
| Mean change ± SD | 4.8 ± 18.9 | 4.1 ± 19.8 |
| Difference a | −0.67 (−2.52–1.18) | |
| Proportion with ≥5 increase | 55.4 | 49.0 |
| Proportion with ≥5 decrease | 28.3 | 35.0 |
COPD, chronic obstructive pulmonary disease; CV, cardiovascular; HF, heart failure; HR, hazard ratio; KCCQ, Kansas City Cardiomyopathy Questionnaire; RR, rate ratio; SD, standard deviation.
Risk and rate ratios adjusted for randomized treatment and previous HF hospitalization at baseline (except non‐CV and all‐cause death) and stratified by diabetes status.
Worsening HF event‐HF hospitalization/urgent visit requiring intravenous therapy for HF.
Model 1 adjusted for age, sex, region, systolic blood pressure, history of atrial fibrillation, New York Heart Association class III/IV, left ventricular ejection fraction, N‐terminal pro B‐type natriuretic peptide (log), estimated glomerular filtration rate and smoking status.
Model 2 adjusted the same as Model 1 and for baseline beta‐blocker and mineralocorticoid receptor antagonist prescription.
Indicates difference in means between patients with COPD and without COPD.