Table 2.
Primary and Secondary Outcomes in Patients With HFpEF With or Without Resistant Hypertension*
| Resistant Hypertension (+) | Resistant Hypertension (−) | |||||
|---|---|---|---|---|---|---|
| Placebo | Spironolactone | P Value | Placebo | Spironolactone | P Value | |
| n=499 | n=505 | n=1221 | n=1216 | |||
| Event | ||||||
| Primary outcome events † | ||||||
| No. of patients | 120 | 90 | 231 | 230 | ||
| Event rate (per 1000 person‐years) | 81.7 | 56.0 | 59.9 | 59.8 | ||
| HR (95% CI) | 1.00 (ref) | 0.70 (0.53–0.91) ‡ | 0.009 ‡ | 1.00 (ref) | 1.00 (0.83–1.20) | 0.97 |
| All‐cause death | ||||||
| No. of patients | 74 | 49 | 199 | 207 | ||
| Event rate (per 1000 person‐years) | 44.4 | 28.2 | 48.4 | 50.7 | ||
| HR (95% CI) | 1.00 (ref) | 0.64 (0.44–0.91) ‡ | 0.01 ‡ | 1.00 (ref) | 1.05 (0.86–1.27) | 0.63 |
| Cardiovascular death | ||||||
| No. of patients | 44 | 31 | 132 | 129 | ||
| Event rate (per 1000 person‐year) | 26.4 | 17.9 | 32.1 | 31.6 | ||
| HR (95% CI) | 1.00 (ref) | 0.68 (0.43–1.07) | 0.09 | 1.00 (ref) | 0.99 (0.77–1.26) | 0.90 |
| Noncardiovascular death | ||||||
| No. of patients | 30 | 18 | 67 | 78 | ||
| Event rate (per 1000 person‐years) | 18.0 | 10.4 | 16.3 | 19.1 | ||
| HR (95% CI) | 1.00 (ref) | 0.58 (0.32–1.03) | 0.06 | 1.00 (ref) | 1.17 (0.84–1.62) | 0.34 |
| Hospitalization for heart failure | ||||||
| No. of patients | 97 | 72 | 148 | 134 | ||
| Event rate (per 1000 person‐years) | 65.8 | 44.8 | 38.3 | 34.9 | ||
| HR (95% CI) | 1.00 (ref) | 0.69 (0.51–0.94) ‡ | 0.01 ‡ | 1.00 (ref) | 0.91 (0.72–1.15) | 0.41 |
| Major cardiovascular events § | ||||||
| No. of patients | 70 | 58 | 194 | 183 | ||
| Event rate (per 1000 person‐years) | 43.6 | 34.4 | 48.8 | 45.9 | ||
| HR (95% CI) | 1.00 (ref) | 0.79 (0.56–1.12) | 0.19 | 1.00 (ref) | 0.94 (0.77–1.15) | 0.56 |
| Myocardial infarction | ||||||
| No. of patients | 19 | 20 | 45 | 45 | ||
| Event rate (per 1000 person‐years) | 11.7 | 11.8 | 11.2 | 11.3 | ||
| HR (95% CI) | 1.00 (ref) | 1.01 (0.54–1.09) | 0.96 | 1.00 (ref) | 1.00 (0.66–1.52) | 0.98 |
| Stroke | ||||||
| No. of patients | 14 | 17 | 46 | 40 | ||
| Event rate (per 1000 person‐years) | 8.6 | 10.0 | 11.4 | 9.9 | ||
| HR (95% CI) | 1.00 (ref) | 1.18 (0.58–2.39) | 0.64 | 1.00 (ref) | 0.87 (0.57–1.33) | 0.52 |
HFpEF indicates heart failure with preserved ejection fraction; and HR, hazard ratio.
a
Data are presented as number or HR (95% CI).
b
The primary outcome was a composite of cardiovascular death, aborted cardiac arrest, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for the management of heart failure.
c
Denotes significance.
d
Major cardiovascular events included cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke.