Table 1. Demographic and Background Characteristics.
| Variable | All Patients (N = 111) | Patients with 18-month PWT (N = 79) | Optimal Medical Care with 18-month PWT (N = 15) | Supervised Exercise with 18-month PWT (N = 32) | Stent with 18-month PWT (N = 32) |
|---|---|---|---|---|---|
| Age, mean ± SD (N), yrs | 64.4 ± 9.5 (111) | 65.0 ± 9.5 (79) | 62.3 ± 8.5 (15) | 65.9 ± 8.8 (32) | 65.2 ± 10.5 (32) |
| Male (%) | 62.2% (69/111) | 62.0% (49/79) | 60.0% (9/15) | 56.3% (18/32) | 68.8% (22/32) |
| Risk factor history | |||||
| Diabetes (%) | 23.9% (26/109) | 24.7% (19/77) | 21.4% (3/14) | 18.8% (6/32) | 32.3% (10/31) |
| Hypertension (%) | 84.7% (94/111) | 87.3% (69/79) | 93.3% (14/15) | 90.6% (29/32) | 81.3% (26/32) |
| Current smoking (%) | 54.1% (60/111) | 53.2% (42/79) | 53.3% (8/15) | 53.1% (17/32) | 53.1% (17/32) |
| Former smoking (%) | 37.8% (42/111) | 38.0% (30/79) | 40.0% (6/15) | 37.5% (12/32) | 37.5% (12/32) |
| Hypercholesterolemia (%) | 80.2% (89/111) | 77.2% (61/79) | 73.3% (11/15) | 78.1% (25/32) | 78.1% (25/32) |
| Statin use (%) | 75.7% (84/111) | 74.7% (59/79) | 73.3% (11/15) | 78.1% (25/32) | 71.9% (23/32) |
| Antiplatelet agent use (%)* | 78.4% (87/111) | 81.0% (64/79) | 86.7% (13/15) | 78.1% (25/32) | 81.3% (26/32) |
| Comorbid cardiovascular diseases | |||||
| Prior TIA (%) | 5.4% (6/111) | 5.1% (4/79) | 6.7% (1/15) | 3.1% (1/32) | 6.3% (2/32) |
| Prior stroke (%) | 8.1% (9/111) | 7.6% (6/79) | 0.0% (0/15) | 18.8% (6/32) | 0.0% (0/32) |
| Prior angina (%) | 2.7% (3/111) | 3.8% (3/79) | 6.7% (1/15) | 0.0% (0/32) | 6.3% (2/32) |
| Prior myocardial infarction (%) | 21.5% (23/107) | 21.8% (17/78) | 33.3% (5/15) | 16.1% (5/31) | 21.9% (7/32) |
| Prior percutaneous coronary revascularization (%) | 18.0% (20/111) | 17.7% (14/79) | 26.7% (4/15) | 9.4% (3/32) | 21.9% (7/32) |
| Prior coronary artery bypass graft (%) | 18.0% (20/111) | 19.0% (15/79) | 13.3% (2/15) | 15.6% (5/32) | 25.0% (8/32) |
| Peripheral artery disease history | |||||
| Prior lower extremity endovascular procedure (%) | 4.5% (5/111) | 3.8% (3/79) | 6.7% (1/15) | 0.0% (0/32) | 6.3% (2/32) |
| Prior lower extremity open surgical revascularization procedure (%) | 3.6% (4/111) | 2.5% (2/79) | 6.7% (1/15) | 0.0% (0/32) | 3.1% (1/32) |
| Cilostazol use prior to randomization (%) | 18.0% (20/111) | 19.0% (15/79) | 13.3% (2/15) | 18.8% (6/32) | 21.9% (7/32) |
| Risk Factors | |||||
| Blood Pressure | |||||
| SBP, mean ± SD (N), mm Hg | 135.6 ± 19.0 (111) | 135.7 ± 19.6 (79) | 136.7 ± 13.4 (15) | 135.9 ± 22.6 (32) | 134.8 ± 19.3 (32) |
| DBP, mean ± SD (N), mm Hg | 74.4 ± 11.4 (110) | 74.0 ± 11.0 (78) | 77.8 ± 10.2 (14) | 74.0 ± 13.0 (32) | 72.3 ± 8.9 (32) |
| Lipid Profile | |||||
| LDL, mean ± SD (N), mg/dl | 103.2 ± 36.4 (107) | 103.6 ± 35.5 (77) | 104.6 ± 40.6 (15) | 97.9 ± 36.3 (31) | 108.8 ± 32.4 (31) |
| HDL, mean ± SD (N), mg/dl | 48.6 ± 14.4 (109) | 49.3 ± 14.9 (79) | 48.5 ± 13.5 (15) | 51.9 ± 16.0 (32) | 47.0 ± 14.4 (32) |
| Triglycerides, Mean ± SD (N), mg/dl | 144.7 ± 108.1 (109) | 149.1 ± 119.1 (79) | 139.8 ± 72.8 (15) | 141.5 ± 83.0 (32) | 161.0 ± 161.8(32) |
| HbA1c, mean ± SD (N), % | 6.2±1.2 (108) | 6.2±1.2 (79) | 6.1±0.7 (15) | 6.0±1.2 (32) | 6.4±1.3 (32) |
| C-reactive protein, mean ± SD (N), mg/dl | 0.99 ± 0.28 (109) | 0.97 ± 0.27 (79) | 0.98 ± 0.27 (15) | 0.96 ± 0.22 (32) | 0.99 ± 0.31 (32) |
| Fibrinogen, mean ± SD (N), mg/dl | 408.0 ± 94.0 (107) | 419.6 ± 90.1 (77) | 428.7 ± 63.3 (15) | 423.1 ± 100.5 (30) | 409.6 ± 92.4 (32) |
| Anthropometric characteristics | |||||
| BMI, mean ± SD (N) | 28.5 ± 5.7 (111) | 28.4 ± 5.7 (79) | 29.0 ± 5.9 (15) | 27.5 ± 5.0 (32) | 28.9 ± 6.4 (32) |
| Waist circumference, mean ± SD (N), cm | 99.9 ± 14.3 (109) | 99.4 ± 14.7 (79) | 100.0 ± 15.4 (15) | 96.5 ± 13.3 (32) | 102.0 ± 15.6 (32) |
| PAD characteristics | |||||
| Prior lower extremity endovascular procedure (%) | 4.5% (5/111) | 3.8% (3/79) | 6.7% (1/15) | 0.0% (0/32) | 6.3% (2/32) |
| Prior lower extremity open surgical revascularization procedure (%) | 3.6% (4/111) | 2.5% (2/79) | 6.7% (1/15) | 0.0% (0/32) | 3.1% (1/32) |
| Prior to randomization use of cilostazol (%) | 18.0% (20/111) | 19.0% (15/79) | 13.3% (2/15) | 18.8% (6/32) | 21.9% (7/32) |
| Baseline Performance, mean ± SD (N) | |||||
| PWT, min | 5.3 ± 2.2 (111) | 5.5 ± 2.3 (79) | 5.7 ± 2.6 (15) | 5.6 ± 2.4 (32) | 5.2 ± 2.1 (32) |
| COT, min | 1.7 ± 0.8 (111) | 1.8 ± 0.9 (79) | 1.8 ± 0.7 (15) | 1.8 ± 0.9 (32) | 1.8 ± 1.0 (32) |
| 7-day free-living steps | 19,294.6 ± 1,2853.0 (81) | 18,517.1 ± 12,731.1 (60) | 18,671.1 ± 15,990.2 (13) | 18,287.6 ± 11,060.1 (25) | 18,687.0 ± 13,013.8 (22) |
| Hourly free-living steps | 286.8 ± 253.0 (93) | 298.2 ± 285.9 (65) | 333.5 ± 461.7 (14) | 301.5 ±230.3 (27) | 273.9 ± 213.6 (24) |
BMI = body mass index; COT = claudication onset time on the graded treadmill test; DBP = diastolic blood pressure; HDL = plasma high-density lipoproteins; LDL = plasma low-density lipoproteins; PAD = peripheral artery disease; PWT = peak walking time on the graded treadmill test; SBP = systolic blood pressure; TIA = transient ischemic attack.
*
Antiplatelet use means use either of aspirin, clopidogrel, or both.