Table 2. Primary and Secondary Endpoints–Patients with 18-Month Visit.
| Difference, 95% CI and p Value* | ||||||
|---|---|---|---|---|---|---|
| Measure | OMC min, mean ± SD, (n) | Supervised Exercise min, mean ± SD, (n) | Stent min, mean ± SD, (n) | Supervised Exercise vs. OMC | Stent vs. OMC | Stent vs. Supervised Exercise |
| PWT | ||||||
|
| ||||||
| Baseline | 5.7 ± 2.6 (15) | 5.6 ± 2.4 (32) | 5.2 ± 2.1 (32) | |||
|
| ||||||
| 18 months | 5.9 ± 2.9 (15) | 10.6 ± 5.7 (32) | 8.4 ± 5.6 (32) | |||
|
| ||||||
| Baseline to 18-month change | 0.2 ± 2.1 (15) | 5.0 ± 5.4 (32) | 3.2 ± 4.7 (32) | 4.7 [2.6,6.9], (p < 0.001) | 3.0 [1.1,5.0], (p = 0.04) | 1.7 [-0.8,4.2], (p = 0.16) |
|
| ||||||
| COT | ||||||
|
| ||||||
| Baseline | 1.8 ± 0.7 (15) | 1.8 ± 0.9 (32) | 1.8 ± 0.9 (32) | |||
|
| ||||||
| 18 months | 2.6 ± 1.7 (15) | 5.1 ± 4.0 (32) | 4.8 ± 4.7 (32) | |||
|
| ||||||
| Baseline to 18-month change | 0.9 ± 1.3 (15) | 3.4 ± 3.9 (32) | 3.0 ± 4.5 (32) | 2.5 [1.0,4.0], (p = 0.03) | 2.2 [0.5,3.9], (p = 0.12) | 0.3 [-1.7,2.4], (p = 0.77) |
|
| ||||||
| ABI | ||||||
|
| ||||||
| Baseline | 0.7 ± 0.2 (15) | 0.7 ± 0.2 (32) | 0.6 ± 0.2 (32) | |||
|
| ||||||
| 18 months | 0.8 ± 0.1 (15) | 0.7 ± 0.2 (32) | 0.9 ± 0.2 (31) | |||
|
| ||||||
| Baseline to 18-month change | 0.0 ± 0.1 (15) | 0.0 ± 0.1 (32) | 0.2 ± 0.2 (31) | -0.0 [-0.1,0.1], (p = 0.82) | 0.2 [0.1,0.3], (p = 0.002) | -0.2 [-0.3,-0.1], (p < 0.001) |
ABI = ankle-brachial index in the most symptomatic leg; CI = confidence interval; OMC = optimal medical care. Other abbreviations as in Table 1.
*
The p values were calculated using change scores, and are on the basis of analysis of covariance, adjusting for study region, baseline cilostazol use, and baseline value of the endpoint.