Overall population (before matching) | Matched population | ||||||
---|---|---|---|---|---|---|---|
Low-Dose DCB Lutonix | High-Dose DCB IN.PACT Admiral | Standardized difference (%) | P value | Low-Dose DCB Lutonix | High-Dose DCB IN.PACT Admiral | Standardized difference (%) | |
(n = 602) | (n = 1905) | (n = 592, weighted n = 592) | (n = 1808, weighter n = 592) | ||||
Patient characteristics | |||||||
Age (years) | 75 ± 9 | 74 ± 9 | 1.3 | 0.79 | 75 ± 9 | 74 ± 9 | 2.7 |
Male sex | 389 (64.6%) | 1237 (64.9%) | 0.7 | 0.93 | 383.0 (64.7%) | 383.1 (64.7%) | 0.0 |
Non-ambulatory | 99 (16.4%) | 224 (11.8%) | 13.5 | 0.003 | 96.0 (16.2%) | 93.8 (15.8%) | 1.0 |
Smoking | 114 (18.9%) | 403 (21.2%) | 5.5 | 0.26 | 112.0 (18.9%) | 115.2 (19.5%) | 1.4 |
Diabetes mellitus | 408 (67.8%) | 1231 (64.6%) | 6.7 | 0.17 | 399.0 (67.4%) | 396.2 (66.9%) | 1.0 |
Chronic kidney disease (CKD) | < 0.001 | ||||||
None | 158 (26.2%) | 602 (31.6%) | 11.9 | 158.0 (26.7%) | 158.1 (26.7%) | 0.0 | |
CKD without dialysis | 222 (36.9%) | 795 (41.8%) | 10.0 | 220.0 (37.2%) | 230.9 (39.0%) | 3.8 | |
CKD on dialysis | 222 (36.9%) | 506 (26.6%) | 22.2 | 214.0 (36.1%) | 203.1 (34.3%) | 3.9 | |
(missing data) | 0 (0.0%) | 2 (0.1%) | 4.6 | 1.00 | 0.0 (0.0%) | 0.0 (0.0%) | 0.0 |
Heart failure | 132 (21.9%) | 330 (17.3%) | 11.6 | 0.013 | 126.0 (21.3%) | 123.1 (20.8%) | 1.2 |
(missing data) | 0 (0.0%) | 1 (0.1%) | 3.2 | 1.00 | 0.0 (0.0%) | 0.0 (0.0%) | 0.0 |
Aspirin use | 466 (77.5%) | 1498 (79.3%) | 4.3 | 0.39 | 459.0 (77.7%) | 458.7 (77.6%) | 0.1 |
(missing data) | 1 (0.2%) | 16 (0.8%) | 9.5 | 0.14 | 1.0 (0.2%) | 1.0 (0.2%) | 0.1 |
P2Y12 inhibitor use | 520 (86.5%) | 1634 (86.2%) | 1.0 | 0.89 | 512.0 (86.6%) | 513.3 (86.9%) | 0.7 |
(missing data) | 1 (0.2%) | 9 (0.5%) | 5.4 | 0.50 | 1.0 (0.2%) | 1.2 (0.2%) | 0.8 |
Cilostazol use | 150 (25.0%) | 473 (25.3%) | 0.7 | 0.93 | 149.0 (25.2%) | 148.8 (25.2%) | 0.1 |
(missing data) | 1 (0.2%) | 32 (1.7%) | 15.9 | 0.008 | 1.0 (0.2%) | 1.4 (0.2%) | 1.4 |
Anticoagulant use | 0.029 | ||||||
None | 484 (80.4%) | 1566 (82.7%) | 6.0 | 479.0 (80.9%) | 482.3 (81.5%) | 1.4 | |
Warfarin use | 61 (10.1%) | 130 (6.9%) | 11.7 | 56.0 (9.5%) | 52.4 (8.9%) | 2.1 | |
DOAC use | 57 (9.5%) | 197 (10.4%) | 3.1 | 57.0 (9.6%) | 57.2 (9.7%) | 0.1 | |
(missing data) | 0 (0.0%) | 12 (0.6%) | 11.3 | 0.11 | 0.0 (0.0%) | 0.0 (0.0%) | 0.0 |
Statin use | 354 (59.1%) | 1160 (61.6%) | 5.1 | 0.30 | 347.0 (58.9%) | 348.4 (59.1%) | 0.5 |
(missing data) | 3 (0.5%) | 22 (1.2%) | 7.3 | 0.24 | 3.0 (0.5%) | 3.1 (0.5%) | 0.2 |
Limb characteristics | |||||||
Rutherford classification | < 0.001 | ||||||
Category 2 | 138 (22.9%) | 509 (26.7%) | 8.8 | 137.0 (23.1%) | 122.6 (20.7%) | 5.9 | |
Category 3 | 210 (34.9%) | 864 (45.4%) | 21.5 | 209.0 (35.3%) | 237.4 (40.1%) | 9.9 | |
Category 4 | 63 (10.5%) | 188 (9.9%) | 2.0 | 63.0 (10.6%) | 67.2 (11.4%) | 2.3 | |
Category 5 | 191 (31.7%) | 344 (18.1%) | 32.0 | 183.0 (30.9%) | 164.8 (27.8%) | 6.7 | |
Ankle–brachial index | 0.62 ± 0.23 | 0.60 ± 0.23 | 7.5 | 0.11 | 0.62 ± 0.23 | 0.62 ± 0.24 | 2.9 |
(missing data) | 26 (4.3%) | 35 (1.8%) | 14.4 | 0.001 | 22.0 (3.7%) | 20.8 (3.5%) | 1.1 |
Aortoiliac lesion | 140 (23.3%) | 418 (22.3%) | 2.3 | 0.66 | 138.0 (23.3%) | 138.5 (23.4%) | 0.2 |
(missing data) | 0 (0.0%) | 30 (1.6%) | 17.9 | 0.004 | 0.0 (0.0%) | 0.0 (0.0%) | 0.0 |
No below-the-knee runoff | 103 (17.1%) | 218 (11.5%) | 16.1 | < 0.001 | 98.0 (16.6%) | 100.0 (16.9%) | 0.9 |
(missing data) | 0 (0.0%) | 6 (0.3%) | 7.9 | 0.37 | 0.0 (0.0%) | 0.0 (0.0%) | 0.0 |
Lesion characteristics | |||||||
History of EVT | 0.021 | ||||||
None (de novo) | 436 (72.4%) | 1455 (76.4%) | 9.1 | 431.0 (72.8%) | 434.1 (73.3%) | 1.2 | |
1 EVT | 87 (14.5%) | 274 (14.4%) | 0.2 | 86.0 (14.5%) | 84.6 (14.3%) | 0.7 | |
≥ 2 EVTs | 79 (13.1%) | 176 (9.2%) | 12.3 | 75.0 (12.7%) | 73.3 (12.4%) | 0.9 | |
In-stent restenosis | 77 (12.8%) | 292 (15.4%) | 7.4 | 0.14 | 76.0 (12.8%) | 78.6 (13.3%) | 1.3 |
(missing data) | 0 (0.0%) | 3 (0.2%) | 5.6 | 0.77 | 0.0 (0.0%) | 0.0 (0.0%) | 0.0 |
Popliteal lesion | 242 (40.2%) | 542 (28.5%) | 24.9 | < 0.001 | 233.0 (39.4%) | 226.3 (38.2%) | 2.3 |
Distal reference vessel diameter (mm) | 4.8 ± 0.9 | 4.9 ± 0.9 | 1.3 | 0.78 | 4.8 ± 0.9 | 4.8 ± 0.9 | 0.7 |
(missing data) | 0 (0.0%) | 18 (0.9%) | 13.8 | 0.034 | 0.0 (0.0%) | 0.0 (0.0%) | 0.0 |
Lesion length (cm) | 13.4 ± 9.1 | 13.8 ± 9.7 | 4.2 | 0.36 | 13.5 ± 9.2 | 13.6 ± 9.6 | 1.3 |
(missing data) | 0 (0.0%) | 1 (0.1%) | 3.2 | 1.00 | 0.0 (0.0%) | 0.0 (0.0%) | 0.0 |
Severe calcification (PACSS grade 4) | 117 (19.5%) | 238 (12.5%) | 19.1 | < 0.001 | 111.0 (18.8%) | 108.7 (18.4%) | 1.0 |
(missing data) | 1 (0.2%) | 0 (0.0%) | 5.8 | 0.54 | 0.0 (0.0%) | 0.0 (0.0%) | 0.0 |
Chronic total occlusion (CTO) | 152 (25.2%) | 531 (27.9%) | 6.0 | 0.22 | 149.0 (25.2%) | 152.6 (25.8%) | 1.4 |
(missing data) | 0 (0.0%) | 3 (0.2%) | 5.6 | 0.77 | 0.0 (0.0%) | 0.0 (0.0%) | 0.0 |
Intravascular ultrasound use | 404 (72.0%) | 1328 (73.4%) | 3.1 | 0.55 | 400.0 (72.1%) | 397.3 (73.3%) | 2.8 |
(missing data) | 41 (6.8%) | 96 (5.0%) | 7.5 | 0.12 | 37.0 (6.2%) | 39.5 (6.7%) | 1.7 |