Table 3.
Peak Walking Time, Claudication Onset Time, ABI, Peak Oxygen Consumption, WIQ and SF-36 Scores, and Their Changes at 3 and 6 Months With GM-CSF and Placeboa
| GM-CSF |
Placebo |
Difference Between GM-CSF and Placebo |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 3 mo | 6 mo | Baseline | 3 mo | 6 mo | 3 mo |
P Valueb |
6 mo |
P Valueb |
|
| PWT, s | 296 (151) | 405 (248) | 411 (253) | 308 (161) | 376 (182) | 386 (209) | ||||
| Change | 109 (67 to 151) | 112 (71 to 153) | 56 (14 to 98) | 77 (36 to 117) | 53 (−6 to 112) | .08 | 35 (−23 to 93) | .24 | ||
| COT, s | 146 (67) | 230 (161) | 233 (158) | 155 (87) | 220 (114) | 216 (129) | ||||
| Change | 81 (52 to 111) | 93 (64 to 122) | 61 (32 to 91) | 61 (33 to 89) | 20 (−22 to 62) | .35 | 32 (−8 to 72) | .12 | ||
| ABI | 0.59 (0.02) | 0.63 (0.02) | 0.61 (0.02) | 0.60 (0.02) | 0.64 (0.03) | 0.65 (0.02) | ||||
| Change | 0.04 (0.008 to 0.06) | 0.02 (−0.003 to 0.05) | 0.03 (0.004 to 0.06) | 0.04 (0.01 to 0.06) | 0.003 (−0.04 to 0.04) | .87 | −0.01 (−0.05 to 0.02) | .45 | ||
| , L/min | 1.25 (0.07) | 1.24 (0.05) | 1.21 (0.04) | 1.25 (0.04) | 1.27 (0.06) | 1.34 (0.06) | ||||
| Change | −0.02 (−0.14 to 0.09) | −0.04 (−0.15 to 0.07) | 0.04 (−0.07 to 0.15) | 0.10 (−0.01 to 0.20) | −0.06 (−0.22 to 0.10) | .46 | −0.13 (−0.29 to 0.02) | .09 | ||
| WIQ scoresc | ||||||||||
| Distance | 25.2 (21.3) | 40.1 (27.6) | 34.5 (27.4) | 29.7 (22.7) | 36.2 (24.8) | 33.1 (24.4) | ||||
| Change | 12.5 (6.4 to 18.7) | 8.0 (2.1 to 14.0) | 4.8 (−0.2 to 9.8) | 3.7 (−0.9 to 8.3) | 7.9 (0.2 to 15.7) | .047 | 4.9 (−2.4 to 12.1) | .19 | ||
| Speed | 36.0 (24.1) | 47.3 (25.3) | 47.5 (23.4) | 36.3 (23.0) | 43.2 (24.5) | 44.7 (22.7) | ||||
| Change | 9.1 (4.2 to 14.0) | 9.9 (4.6 to 15.3) | 7.5 (2.1 to 12.8) | 8.5 (3.8 to 13.2) | 1.5 (−5.7 to 8.8) | .68 | 1.1 (−5.7 to 7.8) | .76 | ||
| Stair climbing | 43.4 (25.4) | 52.9 (26.4) | 54.7 (25.9) | 45.2 (25.0) | 51.4 (28.8) | 52.2 (24.3) | ||||
| Change | 8.5 (3.0 to 13.9) | 10.4 (4.9 to 15.9) | 4.2 (−2.2 to 10.6) | 6.6 (1.2 to 11.9) | 3.6 (−4.4 to 11.6) | .38 | 3.5 (−4.0 to 11.0) | .36 | ||
| SF-36d | ||||||||||
| PCS-36 | 31.1 (7.9) | 35.5 (8.2) | 36.3 (9.1) | 32.3 (7.7) | 34.3 (7.6) | 35.7 (7.0) | ||||
| Change | 4.1 (2.4 to 5.8) | 5.2 (3.3 to 7.0) | 2.1 (0.5 to 3.7) | 3.1 (1.5 to 4.7) | 2.3 (−0.1 to 4.6) | .06 | 1.9 (−0.4 to 4.1) | .11 | ||
| MCS-36 | 49.3 (11.7) | 50.4 (10.3) | 49.5 (10.3) | 47.6 (12.0) | 51.3 (10.9) | 48.6 (10.7) | ||||
| Change | 0.7 (−1.5 to 2.9) | −0.2 (−2.4 to 2.0) | 2.4 (−0.2 to 5.0) | 1.1 (−1.0 to 3.2) | −1.4 (−4.6 to 1.8) | .39 | −1.2 (−4.3 to 1.8) | .42 | ||
| Physical functioning | 40.1 (19.1) | 52.9 (20.6) | 55.1 (19.6) | 41.0 (19.1) | 46.6 (20.0) | 49.4 (17.2) | ||||
| Change | 11.4 (6.7 to 16.1) | 14.3 (9.7 to 18.9) | 4.8 (−0.1 to 9.6) | 8.1 (3.7 to 12.4) | 7.5 (1.0 to 14.0) | .03 | 5.9 (−0.3 to 12.1) | .06 | ||
Abbreviations: ABI, ankle brachial index; COT, claudication onset time; GM-CSF, granulocyte-macrophage colony-stimulating factor; MCS-36, mental composite score; PSC-36, physical composite score; PWT, peak walking time; SF-36, 36-item Short-Form Health Survey; WIQ, walking impairment questionnaire.
Data are presented as absolute mean (standard deviation). For change from baseline, and for differences between groups, data are presented as model-based means (and 95% confidence intervals).
P values refer to differences between GM-CSF and placebo groups by mixed-effects models at 3 months and 6 months.
The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with walking distance, walking speed, and stair-climbing elements.
The SF-36 PCS-36 and MCS-36 are summary measures derived from 8 scale scores, including the physical functioning subscale. Higher scores indicate better performance.