Table 1. Baseline Characteristics of PROPEL Study Participants by Group.
| Baseline Characteristics | No. (%) | ||||
|---|---|---|---|---|---|
| Overall (N = 210) |
Exercise + GM-CSF (n = 53) |
Exercise + Placebo (Exercise Alone) (n = 53) |
Attention Control + GM-CSF (GM-CSF Alone) (n = 53) |
Attention Control+ Placebo (n = 51) |
|
| Age, mean (SD), y | 67.0 (8.6) | 66.6 (9.5) | 67.5 (8.7) | 67.9 (7.5) | 66.0 (8.6) |
| Ankle-brachial index, mean (SD) | 0.70 (0.19) | 0.70 (0.20) | 0.69 (0.19) | 0.71 (0.17) | 0.69 (0.19) |
| Body mass index, mean (SD) | 30.5 (6.6) | 29.7 (6.5) | 31.7 (6.0) | 30.7 (6.9) | 29.9 (6.8) |
| Women | 82 (39) | 20 (38) | 23 (43) | 19 (36) | 20 (39.) |
| Race | |||||
| White | 64 (30) | 18 (34) | 19 (36) | 16 (30) | 11 (22) |
| Black | 141 (67) | 35 (66) | 33 (62) | 35 (66) | 38 (75) |
| Current smoker | 71 (34) | 21 (40) | 20 (38) | 12 (23) | 18 (35) |
| Diabetes | 80 (38) | 18 (34) | 21 (40) | 21 (40) | 20 (39) |
| Myocardial infarction | 46 (22) | 16 (30) | 5 (9) | 14 (26) | 11 (22) |
| Hypertension | 175 (83) | 44 (83) | 44 (83) | 42 (79) | 45 (88) |
| Cancer | 38 (18) | 11 (21) | 7 (13) | 8 (15) | 12 (24) |
| Stroke | 32 (15) | 9 (17) | 5 (9) | 8 (15) | 10 (20) |
| Pulmonary disease | 43 (20) | 12 (23) | 10 (19) | 11 (21) | 10 (20) |
| Intermittent claudication | 64 (30) | 19 (36) | 18 (34) | 11 (21) | 16 (31) |
| Ischemic leg symptoms other than intermittent claudication | 136 (65) | 30 (57) | 33 (62) | 39 (74) | 34 (67) |
| No exertional leg symptoms | 9 (4) | 3 (6) | 2 (4) | 3 (6) | 1 (2) |
| Total treadmill time, mean (SD), min | 7.5 (4.6) | 7.8 (5.4) | 6.5 (4.5) | 8.8 (4.7) | 6.9 (3.4) |
| Maximum relative brachial artery FMD, median (IQR), %a | 5.2 (3.1-7.4) | 4.9 (2.4-7.6) | 5.0 (3.0-7.8) | 5.5 (3.8-7.1) | 5.3 (2.7-7.3) |
| Progenitor cells, mean (SD), %b | |||||
| CD34+CD45lo | 0.03 (0.02) | 0.03 (0.02) | 0.03 (0.01) | 0.03 (0.01) | 0.03 (0.02) |
| CD34+CD45loCD133+ | 0.02 (0.01) | 0.02 (0.01) | 0.02 (0.01) | 0.02 (0.01) | 0.02 (0.01) |
| CD34+CD45loCD31+ | 0.02 (0.01) | 0.03 (0.02) | 0.02 (0.01) | 0.02 (0.01) | 0.03 (0.02) |
| CD34+CD45loCD31+CD133+ | 0.02 (0.01) | 0.02 (0.02) | 0.02 (0.01) | 0.02 (0.01) | 0.02 (0.01) |
Abbreviations: FMD, flow-mediated dilation; IQR, interquartile range; PROPEL, Progenitor Cell Release Plus Exercise to Improve Functional Performance in PAD.
a
Defined as ratio of the maximum brachial artery diameter after reactive hyperemia to the resting diameter. Brachial artery diameters recorded at rest and then 60 and 90 seconds after cuff deflation.
b
Values are percent of total live white blood cells. Notations indicate the specific progenitor cell types. A plus sign indicates the presence of the marker immediately preceding.