Table 2.
Patients with heart failure-related major adverse cardiac events and other significant clinical events by treatment group
| Post-randomozation (n = 125) | MSCs + CPCs (n = 33) | MSCs (n = 29) | CPCs (n = 31) | Placebo (n = 32) | P-value | |
|---|---|---|---|---|---|---|
| Patients with HF-MACE and other significant clinical events* | 43 (34.4) | 10 (30.3) | 9 (31) | 11 (35.5) | 13 (40.6) | 0.828 |
| Patients with HF-MACE | 21 (16 . 8) | 3 (9.1) | 7 (24.1) | 2 (6.5) | 9 (28.1) | 0.049 |
| Death | 11 (8.8) | 2 (6.1) | 3 (10.3) | 2 (6.5) | 4 (12.5) | 0.767 |
| Hospitalization for worsening HF | 14 (11.2) | 2 (6.1) | 4 (13.8) | 1 (3.2) | 7 (21.9) | 0.092 |
| Exacerbation of HF (non-hospitalization) | 2 (1.6) | 0 (0) | 1 (3.4) | 0 (0) | 1 (3.1) | 0.48 |
| Patients with other significant clinical events | 29 (23.2) | 8 (24.2) | 3 (10.3) | 11 (35.5) | 7 (21.9) | 0.148 |
| Non-fatal stroke | 2 (1.6) | 1 (3) | 0 (0) | 0 (0) | 1 (3.1) | 1 |
| Non-fatal MI | 4 (3.2) | 0 (0) | 1 (3.4) | 2 (6.5) | 1 (3.1) | 0.505 |
| Coronary artery revascularization | 7 (5.6) | 2 (6.1) | 1 (3.4) | 2 (6.5) | 2 (6.2) | 1 |
| Ventricular tachycardia/fibrillation | 19 (15.2) | 5 (15.2) | 3 (10.3) | 8 (25.8) | 3 (9.4) | 0.289 |
| Pericardial tamponade | 2 (1.6) | 1 (3) | 0 (0) | 1 (3.2) | 0 (0) | 0.864 |
| Patients with HF-MACE and other significant clinical events – SAEs | 37 (29.6) | 8 (24.2) | 9 (31) | 8 (25.8) | 12 (37.5) | 0.668 |
Values are presented as n (%).
Denominators are per column.
CPC, c-kit positive cardiac cell; HF, heart failure; MACE, major adverse cardiac event; MI, myocardial infarction; MSC, mesenchymal stromal cell; SAE, serious adverse event.
a
Categories of HF-MACE and patients with other significant clinical events are not mutually exclusive.