Table 2.
Standard Group (n = 422) |
Copeptin Group (n = 414) |
Absolute Differenc in MACE Proportion | ||||
---|---|---|---|---|---|---|
MACE at 30 days | ||||||
Yes | 18 | 18 | ||||
No | 398 | 388 | ||||
Unknown (lost to FU) | 6 | 8 | ||||
MACE % (95% CI) | ||||||
Intention to treat analysis | 4.27 (2.55–6.66) (18/422) | 4.34 (2.60–6.78) (18/414) | −0.08 (−2.83) | |||
HR = 1.019 (95% CI: 0.523 to 1.987), p = 0.99 (chi2) | ||||||
Exclusions per protocol deviation | 32 | 74 | ||||
MACE after Exclusions | ||||||
Yes | 17 | 7 | ||||
No | 367 | 325 | ||||
Unknown | 6 | 8 | ||||
MACE % (95% CI) | ||||||
Per protocol analysis | 4.35 (2.56–6.88) (17/390) | 2.05 (0.83–4.20) (7/340) | 2.30 (−0.23) | |||
HR = 0.472 (95% CI: 0.193 to 1.153), p = 0.09 (chi2) |
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.