Table 1. Baseline Characteristics.
| Characteristic | No. (%) | P Value | |||
|---|---|---|---|---|---|
| PAD Only | PAD + CAD | PAD + CVD | PAD + CAD + CVD | ||
| Patients | 7804 (56.2) | 2639 (19.0) | 2049 (14.8) | 1393 (10.0) | |
| Age, median (IQR), y | 65 (59-72) | 66 (61-73) | 67 (61-73) | 68 (63-74) | <.001 |
| Women | 2364 (30.3) | 588 (22.3) | 621 (30.3) | 315 (22.6) | <.001 |
| Region | |||||
| Asia | 1002 (12.8) | 201 (7.6) | 292 (14.3) | 107 (7.7) | <.001 |
| Central/South America | 1131 (14.5) | 358 (13.6) | 160 (7.8) | 91 (6.5) | |
| Europe | 4525 (58.0) | 1251 (47.4) | 1135 (55.4) | 587 (42.1) | |
| North America | 1146 (14.7) | 829 (31.4) | 462 (22.5) | 608 (43.6) | |
| Weight, median (IQR), kg | 75 (65-86) | 80 (69-91) | 75 (65-86) | 80 (70-90) | <.001 |
| Inclusion criteria for randomization | <.001 | ||||
| Previous revascularization | 4238 (54.3) | 1541 (58.4) | 1193 (58.2) | 903 (64.8) | |
| ABI or TBI criteria, mean (SD) | 3566 (45.7) | 1098 (41.6) | 856 (41.8) | 490 (35.2) | |
| ABI value | 0.63 (0.16) | 0.64 (0.14) | 0.62 (0.14) | 0.63 (0.13) | .004 |
| TBI value | 0.52 (0.14) | 0.54 (0.34) | 0.48 (0.19) | 0.53 (0.26) | .49 |
| Limb symptoms | |||||
| Asymptomatic | 1557 (20.0) | 479 (18.2) | 350 (17.1) | 215 (15.4) | <.001 |
| Mild or moderate claudication | 4168 (53.4) | 1415 (53.6) | 1093 (53.3) | 734 (52.7) | |
| Severe claudication | 1678 (21.5) | 638 (24.2) | 525 (25.6) | 387 (27.8) | |
| Pain while at rest | 217 (2.8) | 70 (2.7) | 47 (2.3) | 44 (3.2) | |
| Minor tissue loss | 135 (1.7) | 29 (1.1) | 31 (1.5) | 12 (0.9) | |
| Major tissue loss | 47 (0.6) | 7 (0.3) | 3 (0.1) | 1 (0.1) | |
| Major amputation above the ankle | 212 (2.7) | 47 (1.8) | 41 (2.0) | 39 (2.8) | .02 |
| Minor amputation | 414 (5.3) | 83 (3.1) | 74 (3.6) | 34 (2.4) | <.001 |
| Medical history | |||||
| Stroke | 0 | 0 | 736 (35.9) | 407 (29.2) | NA |
| Transient ischemic attack | 0 | 0 | 300 (14.6) | 207 (14.9) | NA |
| Myocardial infarction | 0 | 1692 (64.1) | 0 | 830 (59.6) | NA |
| Carotid stenosis or carotid revascularization | 0 | 0 | 1423 (69.4) | 1104 (79.3) | NA |
| Diabetes, type 1 or 2 | 2724 (34.9) | 1199 (45.4) | 756 (36.9) | 666 (47.8) | <.001 |
| Hypertension | 5529 (70.8) | 2304 (87.3) | 1743 (85.1) | 1281 (92.0) | <.001 |
| Hyperlipidemia | 5241 (67.2) | 2345 (88.9) | 1607 (78.4) | 1287 (92.4) | <.001 |
| Chronic kidney disease, No./total No. (%)a | 1558/7531 (20.7) | 719/2564 (28.0) | 545/1996 (27.3) | 483/1358 (35.6) | <.001 |
| Tobacco use | n = 7744 | n = 2627 | n = 2042 | n = 1390 | <.001 |
| Current | 2555 (33.0) | 723 (27.5) | 649 (31.8) | 362 (26.0) | <.001 |
| Former | 3365 (43.5) | 1401 (53.3) | 965 (47.3) | 799 (57.5) | <.001 |
| Never | 1824 (23.6) | 503 (19.1) | 428 (21.0) | 229 (16.5) | <.001 |
| Medications | |||||
| Aspirin | 4802 (61.5) | 2045 (77.5) | 1344 (65.6) | 1080 (77.5) | <.001 |
| Clopidogrel | 2045 (26.2) | 978 (37.1) | 782 (38.2) | 668 (48.0) | <.001 |
| DAPT | 841 (10.8) | 617 (23.4) | 356 (17.4) | 453 (32.5) | <.001 |
| Statin | 5123 (65.6) | 2299 (87.1) | 1531 (74.7) | 1228 (88.2) | <.001 |
| ACE inhibitor | 2741 (35.1) | 1318 (49.9) | 872 (42.6) | 704 (50.5) | <.001 |
| Angiotensin receptor blocker | 1850 (23.7) | 705 (26.7) | 571 (27.9) | 362 (26.0) | <.001 |
| Cilostazol | 1254 (16.1) | 363 (13.8) | 297 (14.5) | 181 (13.0) | .002 |
Abbreviations: ABI, ankle-brachial index; ACE, angiotensin-converting enzyme; CAD, coronary artery disease; CVD, cerebrovascular disease; DAPT, dual antiplatelet therapy; IQR, interquartile range; NA, not applicable; PAD, peripheral artery disease; TBI, toe-brachial index.
a
Chronic kidney disease was defined as estimated glomerular filtration rate less than 60 mL/min/1.73 m2.