Table 3. Quality of Life Endpoints—Patients With 18-Month Visit.
| Difference, 95% CI and p Value* | ||||||
|---|---|---|---|---|---|---|
| Measure | OMC (n = 15) (mean ± SD) | Supervised Exercise (n = 32) (mean ± SD) | Stent (n = 32) (mean ± SD) | Supervised Exercise vs. OMC | Stent vs. OMC | Supervised Exercise vs. Stent |
| SF-12 Physical | ||||||
|
| ||||||
| Baseline | 32.3 ± 9.8 (15) | 33.6 ± 9.3 (32) | 34.6 ± 9.1 (32) | |||
|
| ||||||
| 18 months | 31.0 ± 7.6 (14) | 38.0 ± 10.0 (31) | 37.9 ± 9.4 (32) | |||
|
| ||||||
| Baseline to 18-month change† | -1.0 ± 7.6 (14) | 4.3 ± 8.6 (31) | 3.3 ± 11.1 (32) | 5.4 [0.4,10.4], (p = 0.03) | 4.3 [-1.2,9.9], (p = 0.05) | 1.0 [-3.9,5.9], (p = 0.61) |
|
| ||||||
| WIQ Pain Severity | ||||||
|
| ||||||
| Baseline | 28.3 ± 20.8 (15) | 32.8 ± 26.5 (32) | 34.4 ± 28.2 (32) | |||
|
| ||||||
| 18 months | 38.3 ± 24.8 (15) | 63.3 ± 26.2 (32) | 75.0 ± 29.1 (32) | |||
|
| ||||||
| Baseline to 18-month change† | 10.0 ± 24.6 (15) | 30.5 ± 35.8 (32) | 40.6 ± 43.0 (32) | 20.5 [2.9,38.0], (p = 0.02) | 30.6 [11.2,50.0], (p = 0.002) | -10.2 [-29.5,9.2], (p = 0.17) |
|
| ||||||
| WIQ Walking Distance | ||||||
|
| ||||||
| Baseline | 23.3 ± 30.9 (15) | 13.6 ± 12.2 (32) | 15.8 ± 15.6 (32) | |||
|
| ||||||
| 18 months | 19.6 ± 20.7 (15) | 43.0 ± 32.7 (31) | 56.8 ± 37.8 (32) | |||
|
| ||||||
| Baseline to 18-month change† | -3.7 ± 27.6 (15) | 29.9 ± 30.6 (31) | 41.0 ± 34.7 (32) | 33.6 [16.0,51.2], (p < 0.001) | 44.8 [26.4,63.2], (p < 0.001) | -11.2 [-27.3,4.9], (p = 0.16) |
|
| ||||||
| PAQ Physical Limitation | ||||||
|
| ||||||
| Baseline | 33.6 ± 30.4 (14) | 32.4 ± 18.6 (30) | 29.7 ± 20.3 (30) | |||
|
| ||||||
| 18 months | 28.2 ± 17.0 (13) | 44.2 ± 24.0 (30) | 56.8 ± 32.7 (32) | |||
|
| ||||||
| Baseline to 18-month change† | 0.0 ± 24.4 (12) | 9.4 ± 24.4 (28) | 24.4 ± 31.0 (30) | 9.4 [-7.1,25.8], (p = 0.22) | 24.4 [6.7,42.1], (p = 0.01) | -15.1 [-29.4,-0.8], (p = 0.04) |
|
| ||||||
| PAQ Symptoms | ||||||
|
| ||||||
| Baseline | 43.7 ± 17.8 (15) | 42.6 ± 19.2 (32) | 50.4 ± 20.7 (32) | |||
|
| ||||||
| 18 months | 53.0 ± 20.7 (14) | 58.8 ± 24.3 (30) | 74.3 ± 27.7 (32) | |||
|
| ||||||
| Baseline to 18-month change† | 8.1 ± 17.2 (14) | 17.3 ± 22.9 (30) | 23.8 ± 25.6 (32) | 9.2 [-3.0,21.4], (p = 0.19) | 15.7 [3.1,28.3], (p = 0.05) | -6.5 [-18.6,5.6], (p = 0.26) |
|
| ||||||
| PAQ Quality of Life | ||||||
|
| ||||||
| Baseline | 43.9 ± 25.9 (15) | 46.4 ± 19.0 (32) | 43.5 ± 18.3 (32) | |||
|
| ||||||
| 18 months | 49.4 ± 25.3 (13) | 60.3 ± 23.1 (30) | 70.2 ± 27.4 (32) | |||
|
| ||||||
| Baseline to 18-month change† | 5.8 ± 25.5 (13) | 13.3 ± 25.9 (30) | 26.7 ± 28.5 (32) | 7.6 [-9.1,24.3], (p = 0.33) | 20.9 [3.9,38.0], (p = 0.02) | -13.4 [-26.9,0.2], (p = 0.04) |
|
| ||||||
| PAQ Summary | ||||||
|
| ||||||
| Baseline | 46.3 ± 23.6 (15) | 45.8 ± 16.3 (32) | 44.8 ± 18.1 (32) | |||
|
| ||||||
| 18 months | 45.1 ± 21.3 (14) | 58.0 ± 21.6 (31) | 69.1 ± 26.7 (32) | |||
|
| ||||||
| Baseline to 18-month change† | -2.3 ± 19.8 (14) | 12.2 ± 21.5 (31) | 24.3 ± 27.4 (32) | 14.5 [1.6,27.3], (p = 0.03) | 26.5 [12.5,40.6], (p = 0.002) | -12.0 [-24.2,0.1], (p = 0.04) |
The WIQ includes sections to ascertain PAD specificity and differential diagnosis, as well as 14 questions about walking distance, walking speed, and stair climbing. The PAQ consists of 14 questions designed to elicit information about disease-specific quality of life across a range of PAD-specific domains.
PAQ = Peripheral Artery Questionnaire; WIQ = Walking Impairment Questionnaire. Other abbreviations as in Tables 1 and 2.
*
The p values are calculated using change scores, and are based on analysis of covariance adjusting for study center, baseline cilostazol use, and baseline value of the endpoint.
†
Baseline to 18-month change values were calculated only for participants for whom both baseline and 18-month data were collected.