Table 3 Primary and key secondary endpoints for the comparison of the novel integrated care concept (NICC) with standard of care (SoC)
NICC | SoC | RR/OR | p-value | |||
|---|---|---|---|---|---|---|
Events | Mean/percentage (95% CI) | Events | Mean/percentage (95% CI) | |||
Primary endpoints | ||||||
Death, stroke, or myocardial infarction | 6 | 1.5 (0.6–3.3) | 23 | 5.2 (3.3–7.7) | 3.35 (1.36–8.26) | 0.009 |
Number of inpatient treatment days | 5.04 (3.95–6.12) | 6.51 (4.94–8.09) | 1.30 (0.93–1.81) | 0.122 | ||
Death, stroke, myocardial infarction, or cardiac decompensation | 14 | 3.6 (2.0–5.9) | 35 | 8.1 (5.7–11.1) | 2.22 (1.17–4.24) | 0.016 |
Secondary endpoints | ||||||
All-cause mortality | 4 | 1.0 (0.3–2.6) | 23 | 5.3 (3.4–7.8) | 4.43 (1.55–12.62) | 0.006 |
Time-to-event analysis | 5.15 (1.78–14.89) | 0.002 | ||||
Atrial fibrillation | 0 | 0.0 (0.0–3.2) | 8 | 6.7 (2.9–12.7) | ||
Heart failure | 4 | 2.5 (0.7–6.4) | 13 | 7.2 (3.9–12.0) | ||
Treatment-resistant hypertension | 0 | 0.0 (0.0–3.0) | 2 | 1.5 (0.2–5.2) | ||
Cardiovascular death | 3 | 0.8 (0.2–2.2) | 15 | 3.4 (1.9–5.6) | 3.85 (1.16––12.81) | 0.029 |
Atrial fibrillation | 0 | 0.0 (0.0–3.2) | 5 | 4.2 (1.4–9.5) | ||
Heart failure | 3 | 1.9 (0.4–5.5) | 9 | 5.0 (2.3–9.3) | ||
Treatment-resistant hypertension | 0 | 0.0 (0.0–3.0) | 1 | 0.7 (0.0–4.1) | ||
Cardiac decompensation | 8 | 2.0 (0.9–4.0) | 13 | 3.0 (1.6–5.1) | 1.41 (0.58–3.46) | 0.450 |
Major adverse cardiovascular event (MACE) | 5 | 1.3 (0.4–3.0) | 15 | 3.5 (2.0–5.7) | 2.50 (0.89–7.02) | 0.083 |
Time-to-event analysis | 3.41 (1.39–8.37) | 0.008 | ||||
Number of hospitalisations | 0.71 (0.60–0.83) | 0.75 (0.63–0.87) | 1.06 (0.85–1.33) | 0.603 | ||
After adjusting for number of hospitalizations over the 1 year preceding randomisation | 1.01 (0.81–1.26) | 0.908 | ||||