Table 3.
Clinical outcomes between the intraluminal and subintimal groups after being treated with DCB or DES at 2 years.
| Outcomes | DCB, n = 344 | ||||||
|---|---|---|---|---|---|---|---|
| Intraluminal (n = 268, group A) | Subintiaml (n = 83, group C) | Log-rank | Unadjusted | Multivariable-adjusteda | |||
| HR (95% CI) | p | HR (95% CI) | p | ||||
| MALE | 25 (17.1) | 9 (17.8) | 0.947 | 0.974 (0.454–2.090) | 0.947 | 0.897 (0.408–1.973) | 0.788 |
| TLR | 24 (16.8) | 9 (17.8) | 0.871 | 0.939 (0.436–2.022) | 0.871 | 0.862 (0.390–1.905) | 0.713 |
| Loss of clinical patencyb | 118 (64.5) | 33 (57.4) | 0.354 | 1.200 (0.816–1.766) | 0.355 | 1.168 (0.783–1.742) | 0.445 |
| All-cause deathc | 16 (10.5) | 5 (9.0) | 0.917 | 1.055 (0.386–2.885) | 0.917 | 1.177 (0.409–3.387) | 0.762 |
| Outcomes | DES, n = 143 | ||||||
|---|---|---|---|---|---|---|---|
| Intraluminal (n = 76, group B) | Subintiaml (n = 60, group D) | Log-rank | Unadjusted | Multivariable-adjusteda | |||
| HR (95% CI) | p | HR (95% CI) | p | ||||
| MALE | 8 (20.1) | 9 (29.6) | 0.507 | 0.725 (0.279–1.885) | 0.509 | 0.766 (0.255–2.298) | 0.634 |
| TLR | 7 (18.9) | 9 (29.6) | 0.366 | 0.636 (0.236–1.713) | 0.370 | 0.597 (0.190–1.873) | 0.377 |
| Loss of clinical patencyb | 27 (58.2) | 25 (59.1) | 0.487 | 0.825 (0.479–1.422) | 0.488 | 0.858 (0.463–1.591) | 0.626 |
| All-cause deathc | 5 (8.4) | 2 (7.6) | 0.411 | 1.963 (0.381–10.13) | 0.420 | 4.114 (0.650–26.04) | 0.113 |
| Outcomes | Intraluminal (n = 344, group A + B) | Total, n = 487 | |||||
|---|---|---|---|---|---|---|---|
| Subintiaml (n = 143, group C + D) | Log-rank | Unadjusted | Multivariable-adjusteda | ||||
| HR (95% CI) | p | HR (95% CI) | p | ||||
| MALE | 33 (17.8) | 18 (22.0) | 0.455 | 0.803 (0.452–1.428) | 0.456 | 0.753 (0.415–1.366) | 0.351 |
| TLR | 31 (17.3) | 18 (22.0) | 0.345 | 0.756 (0.423–1.353) | 0.347 | 0.695 (0.380–1.271) | 0.237 |
| Loss of clinical patencyb | 145 (63.6) | 58 (58.1) | 0.770 | 1.046 (0.771–1.419) | 0.771 | 1.041 (0.759–1.418) | 0.803 |
| All-cause deathc | 21 (10.2) | 7 (8.1) | 0.600 | 1.257 (0.534–2.959) | 0.601 | 1.548 (0.636–3.765) | 0.335 |
DCB drug-coated balloon group (including bailout stent group), DES drug-eluting stent group, MALE major adverse limb events, TLR clinically driven target lesion revascularization, HR hazard ratio, CI confidence interval, ABI ankle brachial index.
aAdjusted by age, male sex, current smoker, lesion length, and device total length (Supplementary Table S7).
bClinical patency was defined as freedom of symptom aggravation by at least 1 Rutherford category change accompanied by a decrease in ABI > 0.15 or absence of restenosis ≥ 50% on imaging studies such as duplex ultrasound, computed tomographic angiography, or intra-arterialangiography.
cAnalyzed on a per-patient basis, the number of patients was 237, 71, 70, and 56 in Groups A, B, C, and D, respectively.