Table 3.
Event rates and crude and adjusted hazard ratios for primary endpoint, heart failure hospitalization, cardiovascular death, and all-cause death by the ejection fraction group for patients enrolled in the Americas
| Americas (N = 1766) | Ejection fraction group |
Continuous LVEF × treatment interaction | |||
|---|---|---|---|---|---|
| EF <50% (N = 197) | EF 50–54.99% (N = 289) | EF 55–59.99% (N = 422) | EF ≥60% (N = 858) | ||
| Primary endpoint | |||||
| Event rate (per 100 patient-years) | 13.8 (10.8, 17.6) | 13.3 (10.9, 16.3) | 11.6 (9.7, 13.9) | 10.4 (9.1, 11.7) | |
| HR (unadjusted) | 1.31 (0.99, 1.72) | 1.28 (1.01, 1.62) | 1.12 (0.90, 1.39) | Referent | |
| HR (adjusteda) | 1.08 (0.81, 1.44) | 1.13 (0.89, 1.44) | 1.05 (0.84, 1.31) | Referent | |
| Treatment effect (HR) | 0.55 (0.33, 0.91) | 0.83 (0.56, 1.25) | 0.85 (0.60, 1.21) | 0.89 (0.69, 1.15) | P = 0.069 |
| HF hospitalization | |||||
| Event rate (per 100 patient-years) | 9.1 (6.7, 12.3) | 10.7 (8.6, 13.4) | 8.8 (7.2, 10.8) | 8.1 (7.0, 9.3) | |
| HR (unadjusted) | 1.10 (0.79, 1.54) | 1.32 (1.02, 1.72) | 1.09 (0.85, 1.40) | Referent | |
| HR (adjusteda) | 0.91 (0.65, 1.28) | 1.14 (0.87, 1.50) | 1.00 (0.77, 1.28) | Referent | |
| Treatment effect (HR) | 0.60 (0.32, 1.10) | 0.80 (0.51, 1.25) | 0.70 (0.47, 1.06) | 0.95 (0.71, 1.26) | P = 0.037 |
| CV death | |||||
| Event rate (per 100 patient-years) | 6.5 (4.6, 9.0) | 4.4 (3.2, 6.1) | 4.6 (3.5, 5.9) | 3.6 (3.0, 4.4) | |
| HR (unadjusted) | 1.83 (1.24, 2.71) | 1.22 (0.84, 1.78) | 1.26 (0.91, 1.76) | Referent | |
| HR (adjusteda) | 1.65 (1.10, 2.49) | 1.08 (0.74, 1.59) | 1.27 (0.91, 1.78) | Referent | |
| Treatment effect (HR) | 0.46 (0.23, 0.94) | 0.76 (0.40, 1.45) | 0.97 (0.57, 1.64) | 0.73 (0.49, 1.10) | P = 0.93 |
| Death | |||||
| Event rate (per 100 patient-years) | 10.4 (8.1, 13.5) | 7.2 (5.6, 9.2) | 7.7 (6.3, 9.4) | 6.1 (5.2, 7.1) | |
| HR (unadjusted) | 1.77 (1.31, 2.39) | 1.18 (0.88, 1.57) | 1.28 (0.99, 1.64) | Referent | |
| HR (adjusteda) | 1.62 (1.19, 2.23) | 1.03 (0.77, 1.38) | 1.26 (0.98, 1.63) | Referent | |
| Treatment effect (HR) | 0.58 (0.34, 0.99) | 0.92 (0.56, 1.50) | 1.12 (0.75, 1.66) | 0.75 (0.55, 1.03) | P = 0.54 |
The treatment by ejection fraction interaction with LVEF modelled continuously is shown for each endpoint.
HR, hazard ratio; HF, heart failure; CV, cardiovascular; EF, ejection fraction; LVEF, left ventricular ejection fraction.
aAdjusted for NYHA class, diabetes status, creatinine, heart rate, age, race, smoking status, QRS duration, enrolment stratum, atrial fibrillation, peripheral arterial disease, and assignment to spironolactone vs. placebo.