Table 1.
Baseline characteristics of randomized patients
| MSCs + CPCs (n = 33) | MSCs (n = 29) | CPCs (n = 31) | Placebo (n = 32) | |
|---|---|---|---|---|
| Demographics | ||||
| Age (years) | 61.0 ± 11.1 | 61.7 ± 6.7 | 64.2 ± 8.1 | 63.1 ± 8.8 |
| Female sex | 2 (6.06) | 2 (6.90) | 4 (12.90) | 1 (3.13) |
| Race | ||||
| White | 30 (90.91) | 27 (93.10) | 28 (90.32) | 28 (87.50) |
| Black | 3 (9.09) | 0 (0.00) | 0 (0.00) | 2 (6.25) |
| Other | 0 (0.00) | 2 (6.90) | 3 (9.68) | 2 (6.25) |
| Hispanic | 5 (15.15) | 5 (18.52) | 6 (19.35) | 4 (12.50) |
| Physical findings | ||||
| Height (in.) | 69.8 ± 3.1 | 69.1 ± 3.6 | 69.2 ± 3.0 | 69.5 ± 2.7 |
| Weight (lbs) | 216.1 ± 29.4 | 206.5 ± 43.8 | 200.3 ± 38.7 | 206.8 ± 37.9 |
| Body mass index (kg/m2) | 31.2 ± 3.5 | 30.4± 5.4 | 29.4 ± 5.0 | 30.0 ± 4.4 |
| Heart rate (bpm) | 68.4 ± 7.2 | 69.4± 9.1 | 69.7 ± 9.1 | 68.3 ± 11.3 |
| SBP (mmHg) | 118.4 ± 18.2 | 114.0 ± 11 .3 | 117.3 ± 17.9 | 117.2 ± 17.6 |
| DBP (mmHg) | 70.2 ± 9.3 | 70.1 ± 9.0 | 68.3 ± 10.8 | 67.7 ± 11.2 |
| Risk factor history | ||||
| Diabetes | 7 (21.21) | 10 (35.71) | 10 (32.26) | 12 (37.50) |
| Hypertension | 29 (87.88) | 23 (82.14) | 26 (83.87) | 27 (84.38) |
| Smoking | ||||
| Previous | 16 (48.48) | 16 (55.17) | 22 (70.97) | 20 (62.50) |
| Current | 3 (9.09) | 2 (6.90) | 2 (6.45) | 2 (6.25) |
| Heart failure history | ||||
| Hospitalization for HF | 11 (33.33) | 8 (27.59) | 9 (29.03) | 13 (40.63) |
| Emergency department visit for HF | 6 (18.18) | 4 (13.79) | 8 (25.81) | 9 (28.13) |
| Ongoing ischaemia | 9 (27.27) | 5 (17.24) | 4 (12.90) | 7 (21.88) |
| NYHA class | ||||
| I | 1 (3.03) | 1 (3.45) | 3 (9.68) | 1 (3.13) |
| II | 24 (72.73) | 22 (75.86) | 26 (83.87) | 28 (87.50) |
| III | 8 (24.24) | 6 (20.69) | 2 (6.45) | 3 (9.38) |
| Device status | ||||
| Device present | 28 (84.85) | 24 (82.76) | 28 (90.32) | 21 (65.63) |
| ICD | 21 (63.64) | 16 (55.17) | 21 (67.74) | 15 (46.88) |
| Biventricular Pacing and ICD | 7 (21.21) | 8 (27.59) | 7 (22.58) | 6 (18.75) |
| Cardiovascular history | ||||
| Angina (in last 6 months) | 13 (39.39) | 7 (24.14) | 5 (16.13) | 10 (31.25) |
| Canadian classification | ||||
| Class I | 8 (61.54) | 3 (42.86) | 3 (60.00) | 4 (40.00) |
| Class II | 5 (38.46) | 3 (42.86) | 2 (40.00) | 6 (60.00) |
| Class III | 0 (0.00) | 1 (14.29) | 0 (0.00) | 0 (0.00) |
| Class IV | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) |
| MI | ||||
| Number of MIs | 1.6 ± 1.0 | 1 .9 ± 1 .7 | 1 .9 ± 1 .2 | 1.7 ± 1.0 |
| Most recent, STEMI | 7 (70.00) | 14 (66.67) | 10 (55.56) | 9 (69.23) |
| Most recent, anterior | 14 (87.50) | 17 (80.95) | 14 (82.35) | 16 (76.19) |
| PCI | 27 (81.82) | 24 (82.76) | 27 (87.10) | 28 (87.50) |
| CABG | 17 (51.52) | 14 (48.28) | 16 (51.61) | 15 (46.88) |
| Multi-vessel disease | 25 (75.76) | 22 (75.86) | 28 (90.32) | 30 (93.75) |
| Left main disease | 19 (82.61) | 20 (74.07) | 20 (71.43) | 17 (62.96) |
| Proximal LAD involvement | 7 (36.84) | 13 (65.00) | 12 (60.00) | 12 (70.59) |
| Atrial fibrillation | 11 (33.33) | 8 (27.59) | 11 (35.48) | 10 (31.25) |
| Sustained ventricular arrhythmia | 12 (37.50) | 5 (17.24) | 4 (12.90) | 7 (21.88) |
| Valvular heart disease | 22 (66.67) | 17 (58.62) | 26 (83.87) | 24 (75.00) |
| Valvular repair | 1 (3.03) | 0 (0.00) | 3 (9.68) | 3 (9.38) |
| Valvular replacement | 0 (0.00) | 0 (0.00) | 1 (3.23) | 0 (0.00) |
| Peripheral vascular disease | 1 (3.03) | 2 (6.90) | 3 (9.68) | 5 (15.63) |
| Cerebrovascular history | ||||
| Asymptomatic carotid disease | 3 (9.38) | 1 (3.57) | 2 (6.45) | 4 (12.90) |
| Transient ischaemic attack | 0 (0.00) | 4 (13.79) | 4 (12.90) | 2 (6.25) |
| Ischaemic stroke | 1 (3.03) | 6 (20.69) | 2 (6.45) | 3 (9.38) |
| Haemorrhagic stroke | 1 (3.03) | 0 (0.00) | 0 (0.00) | 0 (0.00) |
| Comorbidity history | ||||
| Thyroid disease | 4 (12.50) | 2 (6.90) | 9 (29.03) | 9 (28.13) |
| Liver disease | 0 (0.00) | 0 (0.00) | 0 (0.00) | 1 (3.13) |
| Autoimmune disorder | 1 (3.03) | 3 (10.34) | 2 (6.45) | 2 (6.25) |
| History of malignancy | 2 (6.06) | 2 (6.90) | 1 (3.23) | 5 (15.63) |
| Medications | ||||
| Aspirin | 30 (90.91) | 25 (86.21) | 25 (80.65) | 27 (84.38) |
| Antiplatelet agents (non-aspirin) | 20 (60.61) | 19 (65.52) | 12 (38.71) | 15 (46.88) |
| β-blockers | 32 (96.97) | 26 (89.66) | 29 (93.55) | 31 (96.88) |
| ACE inhibitors | 16 (48.48) | 10 (34.48) | 18 (58.06) | 8 (25.00) |
| Angiotensin II receptor blockers | 8 (24.24) | 5 (17.24) | 6 (19.35) | 9 (28.13) |
| ARNI | 8 (24.24) | 11 (37.93) | 7 (22.58) | 13 (40.63) |
| Ivabradine | 0 (0.00) | 1 (3.45) | 0 (0.00) | 0 (0.00) |
| Aldosterone antagonists | 18 (54.55) | 20 (68.97) | 20 (64.52) | 22 (68.75) |
| Calcium channel blockers | 1 (3.03) | 1 (3.45) | 1 (3.23) | 1 (3.13) |
| Hydralazine | 0 (0.00) | 2 (6.90) | 2 (6.45) | 0 (0.00) |
| Nitrates | 14 (42.42) | 15 (51.72) | 12 (38.71) | 12 (37.50) |
| Statins | 28 (84.85) | 26 (89.66) | 27 (87.10) | 28 (87.50) |
| Diuretics | 18 (54.55) | 19 (65.52) | 19 (61.29) | 24 (75.00) |
| Anticoagulants | 8 (24.24) | 7 (24.14) | 10 (32.26) | 10 (31.25) |
| Non-insulin | 6 (18.18) | 8 (27.59) | 6 (19.35) | 11 (34.38) |
| Insulin | 3 (9.09) | 4 (13.79) | 4 (12.90) | 6 (18.75) |
| Antiarrhythmics | 14 (42.42) | 8 (27.59) | 12 (38.71) | 14 (43.75) |
| PCSK9 Inhibitors | 2 (6.06) | 1 (3.45) | 2 (6.45) | 0 (0.00) |
Values are presented as mean ± standard deviation or n (%); denominators are of those reporting.
ACE, angiotensin-converting enzyme; ARNI, angiotensin receptor–neprilysin inhibitor; CABG, coronary artery bypass graft; CPC, c-kit positive cardiac cell; DBP, diastolic blood pressure; HF, heart failure; ICD, implantable cardioverter-defibrillator; LAD, left anterior descending coronary artery; MI, myocardial infarction; MSC, mesenchymal stromal cell; NYHA, New York Heart Association; PCI, percutaneous coronary intervention; PCSK9, proprotein convertase subtilisin/kexin type 9; SBP, systolic blood pressure; STEMI, ST-elevation myocardial infarction.