Table 1.
Efficacy and safety events with intensive vs. standard blood pressure control in patients with and without heart failure
| Patients with heart failure (n = 326) | Patients without heart failure (n = 9035) | ||||||
|---|---|---|---|---|---|---|---|
| Endpoint | Intensive BP control [no. of patients (%)] | Standard BP control [no. of patients (%)] | Hazard ratio (95% confidence interval) | Intensive BP control [no. of patients (%)] | Standard BP control [no. of patients (%)] | Hazard ratio (95% confidence interval) | P-value for interaction |
| All participants | 166 | 160 | 4512 | 4523 | |||
| Primary endpoint | 22 (13.3%) | 34 (21.3%) | 0.58 (0.34–0.99) | 221 (4.9%) | 285 (6.3%) | 0.77 (0.65–0.92) | 0.33 |
| Secondary endpoints | |||||||
| Myocardial infarction | 3 (1.8%) | 8 (5.0%) | 0.34 (0.09–1.29) | 94 (2.1%) | 108 (2.4%) | 0.87 (0.66–1.15) | 0.16 |
| Other acute coronary syndrome | 3 (1.8%) | 5 (3.1%) | 0.56 (0.13–2.35) | 37 (0.8%) | 35 (0.8%) | 1.06 (0.67–1.68) | 0.40 |
| Stroke | 6 (3.6%) | 6 (3.8%) | 0.92 (0.30–2.85) | 56 (1.2%) | 64 (1.4%) | 0.87 (0.61–1.25) | 0.92 |
| Acute decompensated heart failure | 12 (7.2%) | 18 (11.3%) | 0.61 (0.29–1.27) | 50 (1.1%) | 82 (1.8%) | 0.61 (0.43–0.86) | >0.99 |
| Death from cardiovascular causes | 5 (3.0%) | 7 (4.4%) | 0.66 (0.21–2.08) | 32 (0.7%) | 58 (1.3%) | 0.55 (0.36–0.85) | 0.76 |
| Death from any cause | 12 (7.2%) | 18 (11.3%) | 0.62 (0.30–1.29) | 143 (3.2%) | 192 (4.2%) | 0.74 (0.60–0.92) | 0.64 |
| Primary endpoint with death from any cause | 26 (15.7%) | 42 (26.3%) | 0.55 (0.34–0.90) | 306 (6.8%) | 381 (8.4%) | 0.80 (0.69–0.93) | 0.17 |
| Composite serious adverse events | 97 (58.4%) | 90 (56.3%) | 1.01 (0.76–1.35) | 1696 (37.6%) | 1646 (36.4%) | 1.04 (0.97–1.11) | 0.83 |
| Emergency department visit or serious adverse events | |||||||
| Hypotension | 13 (7.8%) | 6 (3.8%) | 2.07 (0.79–5.44) | 145 (3.2%) | 87 (1.9%) | 1.68 (1.29–2.19) | 0.71 |
| Syncope | 8 (4.8%) | 7 (4.4%) | 1.08 (0.39–2.97) | 155 (3.4%) | 106 (2.3%) | 1.47 (1.15–1.88) | 0.53 |
| Bradycardia | 11 (6.6%) | 8 (5.0%) | 1.29 (0.52–3.21) | 93 (2.1%) | 75 (1.7%) | 1.24 (0.92–1.68) | 0.95 |
| Electrolyte abnormality | 8 (4.8%) | 8 (5.0%) | 0.92 (0.34–2.45) | 169 (3.8%) | 121 (2.7%) | 1.40 (1.11–1.77) | 0.43 |
| Injurious fall | 18 (10.8%) | 19 (11.9%) | 0.86 (0.45–1.64) | 316 (7.0%) | 313 (6.9%) | 1.01 (0.86–1.18) | 0.59 |
| Acute kidney injury or renal failure | 18 (10.8%) | 13 (8.1%) | 1.30 (0.63–2.64) | 186 (4.1%) | 107 (2.4%) | 1.75 (1.38–2.22) | 0.41 |
| Orthostatic hypotension alone | 40 (24.1%) | 42 (26.3%) | 0.74 (0.47–1.41) | 737 (16.3%) | 815 (18.0%) | 0.89 (0.81–0.98) | 0.37 |
| Orthostatic hypotension with dizziness | 4 (2.4%) | 2 (1.3%) | 1.87 (0.34–10.21) | 58 (1.3%) | 69 (1.5%) | 0.83 (0.58–1.17) | 0.50 |
BP, blood pressure.