Table 2.
Clinical outcomes between the DCB and DES Groups according to different approaches at 2 years.
| Outcomes | Intraluminal, n = 344 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| DCB (n = 268, group A) | DES (n = 76, group B) | Log-rank | Unadjusted | Multivariable-adjusteda | Propensity score-adjusted | ||||
| HR (95% CI) | p | HR (95% CI) | p | HR (95% CI) | p | ||||
| MALE | 25 (17.1) | 8 (20.1) | 0.369 | 0.695 (0.312–1.546) | 0.372 | 0.533 (0.212–1.338) | 0.180 | 0.654 (0.284–1.506) | 0.318 |
| TLR | 24 (16.8) | 7 (18.9) | 0.506 | 0.751 (0.323–1.750) | 0.508 | 0.541 (0.209–1.397) | 0.204 | 0.682 (0.286–1.627) | 0.388 |
| Loss of clinical patencyb | 118 (64.5) | 27 (58.2) | 0.863 | 1.038 (0.683–1.577) | 0.863 | 1.281 (0.799–2.055) | 0.304 | 1.037 (0.676–1.593) | 0.866 |
| All-cause deathc | 16 (10.5) | 5 (8.4) | 0.728 | 1.195 (0.437–3.265) | 0.728 | 1.285 (0.347–4.760) | 0.708 | 0.838 (0.294–2.393) | 0.742 |
| Outcomes | Subintimal, n = 143 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| DCB (n = 83, group C) | DES (n = 60, group D) | Log-rank | Unadjusted | Multivariable-adjusteda | Propensity score-adjusted | ||||
| HR (95% CI) | p | HR (95% CI) | p | HR (95% CI) | p | ||||
| MALE | 9 (17.8) | 9 (29.6) | 0.197 | 0.549 (0.218–1.385) | 0.204 | 0.525 (0.181–1.524) | 0.236 | 0.432 (0.051–3.668) | 0.442 |
| TLR | 9 (17.8) | 9 (29.6) | 0.197 | 0.549 (0.218–1.385) | 0.204 | 0.525 (0.181–1.524) | 0.236 | 0.432 (0.051–3.668) | 0.442 |
| Loss of clinical patencyb | 33 (57.4) | 25 (59.1) | 0.263 | 0.744 (0.442–1.252) | 0.265 | 0.909 (0.487–1.694) | 0.764 | 0.891 (0.315–2.522) | 0.828 |
| All-cause deathc | 5 (9.0) | 2 (7.6), | 0.565 | 1.616 (0.310–8.418) | 0.569 | 1.553 (0.209–11.56) | 0.667 | 1.197 (0.225–6.381) | 0.833 |
| Outcomes | Total, n = 487 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| DCB (n = 351, group A + C) | DES (n = 136, group B + D) | Log-rank | Unadjusted | Multivariable-adjusteda | Propensity score-adjusted | ||||
| HR (95% CI) | p | HR (95% CI) | p | HR (95% CI) | p | ||||
| MALE | 34 (17.2) | 17 (24.6) | 0.100 | 0.615 (0.343–1.103) | 0.103 | 0.549 (0.281–1.073) | 0.079 | 0.579 (0.309–1.086) | 0.089 |
| TLR | 33 (16.9) | 16 (24.0) | 0.126 | 0.629 (0.346–1.145) | 0.129 | 0.552 (0.280–1.089) | 0.087 | 0.582 (0.306–1.107) | 0.099 |
| Loss of clinical patencyb | 151 (62.8) | 52 (58.8) | 0.623 | 1.082 (0.789–1.484) | 0.624 | 1.256 (0.880–1.793) | 0.210 | 0.981 (0.513–1.877) | 0.953 |
| All-cause deathc | 21 (10.1) | 7 (8.2) | 0.923 | 1.043 (0.443–2.457) | 0.923 | 1.179 (0.403–3.447) | 0.764 | 0.942 (0.391–2.273) | 0.895 |
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, previous history of stroke, current smoker, lesion length, stent mean diameter, stent total length, and post-procedural ABI (Supplementary Table S6).
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.