Table 1.
Baseline characteristics.
| Variables | Intraluminal approach (n = 344) | Subintimal approach (n = 143) | ||||
|---|---|---|---|---|---|---|
| DCB (n = 268, group A) | DES (n = 76, group B) | p value | DCB (n = 83, group C) | DES (n = 60, group D) | p value | |
| Age, years | 68.6 ± 11.9 | 69.7 ± 9.2 | 0.395 | 69.4 ± 11.7 | 71.9 ± 10.2 | 0.179 |
| Male, n (%) | 216 (80.6) | 61 (80.3) | 0.948 | 77 (92.8) | 47 (78.3) | 0.023 |
| BMI, kg/m2 | 23.5 ± 3.2 | 23.1 ± 3.9 | 0.455 | 23.1 ± 3.4 | 23.0 ± 4.0 | 0.968 |
| Hypertension, n (%) | 205 (76.5) | 52 (68.4) | 0.178 | 60 (72.3) | 41 (68.3) | 0.710 |
| Diabetes mellitus, n (%) | 160 (59.7) | 42 (55.3) | 0.511 | 41 (49.4) | 25 (41.7) | 0.398 |
| Dyslipidemia, n (%) | 169 (63.1) | 45 (59.2) | 0.592 | 45 (54.2) | 39 (65.0) | 0.230 |
| Coronary artery disease, n (%) | 99 (36.9) | 30 (39.5) | 0.689 | 31 (37.3) | 23 (38.3) | 0.905 |
| Heart failure, n (%) | 12 (4.5) | 4 (5.3) | 0.760 | 6 (7.2) | 2 (3.3) | 0.468 |
| Chronic kidney disease, n (%) | 70 (26.1) | 13 (17.1) | 0.129 | 22 (26.5) | 15 (25.0) | 0.839 |
| COPD, n (%) | 8 (3.0) | 4 (5.3) | 0.309 | 4 (4.8) | 4 (6.7) | 0.720 |
| Previous history of stroke, n (%) | 53 (19.8) | 6 (7.9) | 0.015 | 10 (12.0) | 8 (13.3) | 0.805 |
| Previous history of PTA, n (%) | 78 (29.1) | 18 (23.7) | 0.388 | 21 (25.3) | 18 (30.0) | 0.572 |
| Previous history of amputation, n (%) | 15 (5.6) | 2 (2.6) | 0.381 | 2 (2.4) | 1 (1.7) | 0.760 |
| Current smoker, n (%) | 78 (29.1) | 18 (23.7) | 0.388 | 23 (27.7) | 26 (43.3) | 0.074 |
| Clinical presentation | 0.342 | 0.735 | ||||
| Claudication, n (%) | 169 (63.1) | 53 (69.7) | 44 (53.0) | 34 (56.7) | ||
| CLTI, n (%) | 99 (36.9) | 23 (30.3) | 39 (47.0) | 26 (43.3) | ||
| Discharge medications | ||||||
| Aspirin, n (%) | 230 (85.8) | 70 (92.1) | 0.148 | 66 (79.5) | 53 (88.3) | 0.182 |
| Clopidogrel, n (%) | 235 (87.7) | 70 (92.1) | 0.411 | 71 (85.5) | 55 (91.7) | 0.306 |
| Cilostazol, n (%) | 80 (29.9) | 16 (21.1) | 0.149 | 33 (39.8) | 15 (25.0) | 0.075 |
| Statin, n (%) | 216 (80.6) | 58 (76.3) | 0.422 | 62 (74.7) | 49 (81.7) | 0.417 |
| Lesion length, mm | 220.1 ± 111.5 | 191.7 ± 102.9 | 0.039 | 263.9 ± 116.2 | 255.5 ± 91.9 | 0.630 |
| ≥ 150 mm, n (%) | 203 (75.7) | 47 (61.8) | 0.020 | 71 (85.5) | 53 (88.3) | 0.627 |
| TASC-II type | 0.143 | 0.928 | ||||
| A/B, n (%) | 76 (28.4) | 15 (19.7) | 12 (14.5) | 9 (15.0) | ||
| C/D, n (%) | 192 (71.6) | 61 (80.3) | 71 (85.5) | 51 (85.0) | ||
| Moderate/severe calcification, n (%) | 90 (33.6) | 29 (38.2) | 0.495 | 25 (30.1) | 16 (26.7) | 0.710 |
| DCB plus bailout stenting, n (%) | 55 (20.5) | 0 | 34 (41.0) | 0 | ||
| Device maximum diameter, mma | 6.03 ± 0.41 (n = 265) | 6.36 ± 0.51 (n = 75) | < 0.001 | 6.23 ± 0.42 (n = 81) | 6.48 ± 0.57 (n = 58) | 0.004 |
| Device mean diameter, mma | 5.92 ± 0.39 (n = 265) | 6.23 ± 0.37 (n = 75) | < 0.001 | 6.04 ± 0.45 (n = 81) | 6.24 ± 0.36 (n = 58) | 0.003 |
| Device total length, mma | 182.9 ± 59.0 (n = 265) | 187.0 ± 96.6 (n = 75) | 0.729 | 211.9 ± 79.2 (n = 81) | 200.7 ± 90.3 (n = 58) | 0.443 |
| Stent maximum diameter, mmb | 6.35 ± 0.39 (n = 53) | 6.36 ± 0.51 (n = 75) | 0.849 | 6.62 ± 0.50 (n = 33) | 6.48 ± 0.57 (n = 58) | 0.151 |
| Stent mean diameter, mmb | 6.28 ± 0.38 (n = 53) | 6.23 ± 0.37 (n = 75) | 0.271 | 6.43 ± 0.61 (n = 33) | 6.24 ± 0.36 (n = 58) | 0.019 |
| Stent total length, mmb | 139.4 ± 31.6 (n = 53) | 187.0 ± 96.6 (n = 75) | < 0.001 | 150.8 ± 47.0 (n = 33) | 200.7 ± 90.3 (n = 58) | < 0.001 |
| Pre-procedural ABIc | 0.56 ± 0.18 (n = 218) | 0.57 ± 0.17 (n = 67) | 0.831 | 0.55 ± 0.18 (n = 67) | 0.57 ± 0.19 (n = 53) | 0.644 |
| Post-procedural ABId | 0.86 ± 0.14 (n = 170) | 0.91 ± 0.14 (n = 48) | 0.010 | 0.86 ± 0.15 (n = 51) | 0.90 ± 0.13 (n = 43) | 0.049 |
| Atherectomy | ||||||
| Directional, n (%) | 19 (7.1) | 2 (2.6) | 0.184 | 1 (1.2) | 0 | 0.394 |
| Rotational, n (%) | 33 (12.3) | 2 (2.6) | 0.010 | 4 (4.8) | 0 | 0.139 |
| Concomitant treatment | ||||||
| Iliac lesion, n (%) | 41 (15.3) | 11 (14.5) | 0.859 | 17 (20.5) | 9 (15.0) | 0.511 |
| Infrapopliteal lesion, n (%) | 57 (21.3) | 9 (11.8) | 0.071 | 8 (9.6) | 7 (11.7) | 0.785 |
| Approach direction | ||||||
| Ipsilateral retrograde, n (%) | 130 (48.5) | 40 (52.6) | 0.603 | 45 (54.2) | 25 (41.7) | 0.175 |
| Contralateral antegrade, n (%) | 122 (45.5) | 33 (43.4) | 0.795 | 34 (41.0) | 27 (45.0) | 0.732 |
| Bidirectional, n (%) | 16 (6.0) | 3 (3.9) | 0.776 | 4 (4.8) | 8 (13.3) | 0.123 |
| Technical success, n (%) | 257 (95.9) | 73 (96.1) | 0.951 | 82 (98..8) | 58 (96.7) | 0.354 |
| Kinds of devicee | ||||||
| IN.PACT, n (%) | 216 (80.6) | 69 (83.1) | ||||
| Lutonix, n (%) | 27 (10.1) | 13 (15.7) | ||||
| Ranger, n (%) | 25 (9.3) | 1 (1.2) | ||||
| Eluvia, n (%) | 54 (71.1) | 30 (50.0) | ||||
| Zilver PTX, n (%) | 22 (28.9) | 30 (50.0) | ||||
| Complications | ||||||
| Distal embolization, n (%) | 0 | 1 (1.3) | 0.221 | 0 | 0 | – |
| Vascular rupture, n (%) | 3 (1.1) | 0 | 0.354 | 1 (1.2) | 0 | 0.694 |
| Bleeding, n (%) | 7 (2.6) | 0 | 0.355 | 2 (2.4) | 0 | 0.510 |
| Follow-up duration, days | 342 (166–680) | 240 (129–411) | 0.028 | 421 (183–693) | 212 (117–584) | 0.013 |
Values are means ± standard deviation or median (interquartile range) or numbers and percentages.
DCB drug-coated balloon group (including bailout stent group), DES drug-eluting stent group, BMI body mass index, COPD chronic obstructive pulmonary disease, PTA percutaneous transluminal angioplasty, CLTI chronic limb-threatening ischemia, TASC-II Trans-Atlantic Inter-Society Consensus-II.
The p values for continuous data were obtained from the unpaired t-test. The p values for categorical data from chi-square or Fisher’s exact test.
aData is available for 265, 75, 81, 58 limbs in Groups A, B, C, and D, respectively.
bData is available for 53, 75, 33, 58 limbs in Groups A, B, C, and D, respectively.
cData is available for 218, 67, 67, 53 limbs in Groups A, B, C, and D, respectively.
dData is available for 170, 48, 51, 43 limbs in Groups A, B, C, and D, respectively.
eIN.PACT (Medtronic Inc., Santa Rosa, CA, USA), Lutonix (Bard, Tempe, AZ, USA), Ranger (Boston Scientific, Marlborough, MA, USA), Eluvia (Boston Scientific, Marlborough, MA, USA), Zilver PTX (Cook Medical, IN, USA).