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. 2022 Jan 8;11(2):211. doi: 10.3390/cells11020211

Table 2.

Primary endpoint analyses.

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.