A1.
Quality‐of‐Life End Points at Baseline and 18 Months
| Measure | OMC (n=20) (Mean±SD) | SE (n=37) (Mean±SD) | ST (n=41) (Mean±SD) | Difference [95% CI], (P Value)* | ||
|---|---|---|---|---|---|---|
| SE vs OMC | ST vs OMC | ST vs SE | ||||
| SF‐12 physical | ||||||
| Baseline | 31.6±10.5 (20) | 32.5±9.0 (37) | 34.3±9.3 (41) | 4.6 [0.2 to 9.0], (P=0.02) |
3.5 [−1.2 to 8.1], (P=0.07) |
1.1 [−3.0 to 5.2], (P=0.52) |
| 18 months | 30.2±7.2 (19) | 36.7±9.9 (37) | 36.9±9.4 (40) | |||
| Baseline to 18‐month change | −0.4±7.7 (19) | 4.2±8.2 (37) | 3.0±10.1 (40) | |||
| WIQ pain severity | ||||||
| Baseline | 28.4±20.8 (20) | 31.8±26.1 (37) | 33.7±27.5 (41) | 18.9 [−1.7 to 39.5], (P=0.03) |
20.6 [−0.4 to 41.6], (P=0.03) |
−1.6 [−20.3 to 17.1], (P=0.81) |
| 18 months | 42.2±24.8 (16) | 65.4±26.8 (34) | 71.7±28.6 (38) | |||
| Baseline to 18‐month change | 15.6±32.8 (16) | 34.6±38.4 (34) | 36.2±42.6 (38) | |||
| WIQ walking distance | ||||||
| Baseline | 22.9±26.8 (20) | 13.9±12.0 (37) | 17.9±15.5 (41) | 34.0 [17.1 to 50.8], (P<0.001) |
38.6 [21.3 to 55.9], (P<0.001) |
−4.7 [−20.2 to 10.9], (P=0.53) |
| 18 months | 18.7±20.3 (16) | 43.5±33.1 (33) | 52.5±37.0 (38) | |||
| Baseline to 18‐month change | −3.4±26.7 (16) | 30.6±31.1 (33) | 35.3±35.6 (38) | |||
| PAQ physical limitation | ||||||
| Baseline | 32.9±27.0 (20) | 31.5±18.0 (35) | 30.5±19.5 (41) | 10.3 [−3.4 to 24.0], (P=0.12) |
20.5 [5.7 to 35.4], (P=0.01) |
−10.2 [−23.6 to 3.1], (P=0.12) |
| 18 months | 28.5±16.9 (18) | 44.2±24.4 (36) | 53.9±31.4 (40) | |||
| Baseline to 18‐month change | 0.7±22.6 (17) | 11.0±25.4 (34) | 21.3±32.2 (38) | |||
| PAQ symptoms | ||||||
| Baseline | 43.3±19.7 (20) | 40.5±19.4 (37) | 48.2±21.1 (41) | 9.7 [−0.7 to 20.2], (P=0.10) |
17.0 [6.0, to 28.0], (P=0.02) |
−7.3 [−18.9 to 4.3], (P=0.18) |
| 18 months | 49.7±21.3 (19) | 57.0±25.2 (36) | 73.3±26.9 (41) | |||
| Baseline to 18‐month change | 7.9±15.5 (19) | 17.6±24.0 (36) | 24.9±27.9 (41) | |||
| PAQ quality of life | ||||||
| Baseline | 44.4±25.5 (20) | 44.0±19.7 (36) | 46.1±19.4 (41) | 6.6 [−7.3 to 20.5], (P=0.34) |
19.7 [5.3 to 34.2], (P=0.01) |
−13.1 [−25.3 to −1.0], (P=0.02) |
| 18 months | 48.4±27.5 (18) | 56.5±24.8 (36) | 71.0±25.5 (41) | |||
| Baseline to 18‐month change | 5.8±24.5 (18) | 12.4±24.5 (35) | 25.5±29.5 (41) | |||
| PAQ summary | ||||||
| Baseline | 45.6±23.3 (20) | 43.6±16.4 (37) | 45.3±18.3 (41) | 13.5 [3.1 to 23.9], (P=0.02) |
23.8 [12.0 to 35.6], (P=0.001) |
−10.3 [−21.3 to 0.7], (P=0.05) |
| 18 months | 43.5±21.6 (19) | 56.0±22.0 (37) | 68.2±24.8 (41) | |||
| Baseline to 18‐month change | −1.1±17.7 (19) | 12.4±20.8 (37) | 22.7±28.4 (41) | |||
Results are shown using all available data. P values are based on analysis of covariance adjusting for study center, baseline cilostazol use, and baseline value of the end point. For each of these scales, higher scores indicate fewer symptoms or better quality of life. OMC indicates optimal medical care; PAQ, peripheral artery questionnaire; SE, supervised exercise; SF‐12, short‐form 12; ST, stent; WIQ, walking impairment questionnaire.
*
P values for change from baseline to 18 months are based on ANCOVA with adjustment for study center, baseline cilostazol use, and baseline score.