Table 2.
Primary endpoint analyses
| Standard group (n = 451) | Copeptin group (n = 451) | Absolute difference in MACE proportion (97.5% one-sided CI) | |
|---|---|---|---|
| MACE at 30 days | |||
| Yes | 23 | 23 | – |
| No | 422 | 422 | – |
| Unknown | 6 | 8 | – |
| MACE % (95% CI): (absolute numbers) | |||
| Intention to treat analysis | 5.17 (3.30–7.65) (23/445) | 5.19 (3.32–7.69) (23/443) | −0.02 (−2.94) |
| Per protocol analysis | 5.34 (3.38–7.97) (22/412) | 3.01 (1.51–5.33) (11/365) | 2.33 (−0.46) |
| Sensitivity analyses | |||
| Assuming poor outcome | 6.43 (4.35–9.10) (29/451) | 6.87 (4.72–9.61) (31/451) | −0.44 (−3.70) |
| Assuming good outcome | 5.10 (3.26–7.55) (23/451) | 5.10 (3.26–7.55) (23/451) | 0.00 (−2.87) |
| Extreme case: favouring standard group | 5.10 (3.26–7.55) (23/451) | 6.87 (4.72–9.61) (31/451) | −1.77 (−4.87) |
| Extreme case: favouring copeptin group | 6.43 (4.35–9.10) (29/451) | 5.10 (3.26–7.55) (23/451) | 1.33 (−1.71) |
Analysis of the primary endpoint: All MACE within 30 days.
The CIs for the absolute difference between the proportions in the respective study groups did not exceed the 5% non-inferiority margin in any analysis, confirming non-inferiority of the copeptin based process as hypothesized, even if the worst case was assumed.