Table 2.
Safety endpoints stratified by baseline PVS cut‐off
| PVS ≤ −4% (n = 255) | PVS > −4% (n = 181) | |||||
|---|---|---|---|---|---|---|
| Endpoint or event | Number of events | Incidence/ (100 patient‐year at risk) | Number of events | Incidence/ (100 patient‐year at risk) | Hazard ratio 95% CI | P value |
| Any hospitalization or deatha | 23 | 20 (16.7) | 32 | 25 (31.6) | 1.89 (1.05–3.40) | 0.031 |
| Any death | 3 | 3 (2.4) | 6 | 6 (7.1) | 2.94 (0.74–11.76) | 0.11 |
| Cardiovascular death | 3 | 3 (2.4) | 5 | 5 (5.9) | 2.45 (0.58–10.25) | 0.21 |
| Death due to worsening CHF | 1 | 1 (0.8) | 2 | 2 (2.4) | 2.93 (0.27–32.35) | 0.36 |
| Any hospitalization | 20 | 17 (14.2) | 26 | 21 (26.5) | 1.86 (0.98–3.53) | 0.053 |
| Any hospitalization for any cardiovascular reason | 15 | 14 (11.6) | 18 | 14 (17.3) | 1.48 (0.71–3.11) | 0.30 |
| Any hospitalization for worsening CHF | 7 | 6 (4.9) | 9 | 7 (8.4) | 1.74 (0.58–5.18) | 0.31 |
| Any hospitalization for any cardiovascular reason or death | 18 | 17 (14.1) | 24 | 18 (22.2) | 1.57 (0.81–3.05) | 0.18 |
| Any hospitalization for worsening CHF or death | 10 | 9 (7.3) | 15 | 12 (14.4) | 1.98 (0.84–4.71) | 0.11 |
| Any hospitalization or death for any cardiovascular reason | 18 | 17 (14.1) | 23 | 17 (21.0) | 1.48 (0.76–2.91) | 0.25 |
| Any hospitalization or death for worsening CHF | 8 | 7 (5.7) | 11 | 8 (9.6) | 1.70 (0.62–4.69) | 0.30 |
Only unplanned hospitalizations and deaths are summarized. CHF, chronic heart failure; PVS, plasma volume status.
a
Key endpoint.