Table 3.
Clinical effectiveness outcomes at the 12 months and last follow-up.a.
| DCB | nSFA | Z/χ2 | P | |||
|---|---|---|---|---|---|---|
| At baseline | 3（3,4） | 3（3,4） | −1.316 | 0.188 | ||
| At the 12-months | N = 54 limbs | N = 56 limbs | ||||
| Change in Rutherford class | ||||||
| marked improvement(-4) | 7（13.0%） | 0（0.0%） | / | 1.000 | ||
| moderate improvement (−3) | 8（14.8%） | 2（3.6%） | 2.955 | 0.086 | ||
| mild improvement(-2) | 13（24.1%） | 13（23.2%） | 0.011 | 0.915 | ||
| minimal improvement(-1) | 15（27.8%） | 21（37.5%） | 1.180 | 0.277 | ||
| no change(0) | 10（18.4%） | 16（28.6%） | 1.539 | 0.215 | ||
| mildly worse(+1) | 1（1.9%） | 4（7.1%） | / | 0.364 | ||
| moderately worse(+2) | 0（0.0%） | 0（0.0%） | / | / | ||
| Improvement of Rutherford | ||||||
| markedly effective rate | 28(51.9%) | 15(26.8%) | 7.254 | 0.007 | ||
| the effective rate | 15(27.8%) | 21(37.5%) | 1.180 | 0.277 | ||
| total effective rate | 43(79.7%) | 36(64.3%) | 3.198 | 0.074 | ||
| ineffective rate | 10(18.4%) | 16(28.6%) | 1.539 | 0.215 | ||
| deterioration rate | 1(1.9%) | 4(7.1%) | / | 0.364 | ||
| At the last follow up | N = 54 limbs | N = 56 limbs | ||||
| Change in Rutherford class | ||||||
| marked improvement(-4) | 6（11.1%） | 2（3.6%） | 1.334 | 0.248 | ||
| moderate improvement (−3) | 6（11.1%） | 6（10.7%） | 0.004 | 0.947 | ||
| mild improvement(-2) | 9（16.6%） | 19（33.9%） | 4.317 | 0.038 | ||
| minimal improvement(-1) | 12（22.2%） | 12（21.4%） | 0.010 | 0.920 | ||
| no change(0) | 19（35.2%） | 15（26.8%） | 0.908 | 0.341 | ||
| mildly worse(+1) | 1（1.9%） | 1（1.8%） | / | 1.000 | ||
| moderately worse(+2) | 1（1.9%） | 1（1.8%） | / | 1.000 | ||
| Improvement of Rutherford | ||||||
| markedly effective rate | 21(38.8%) | 27(48.2%) | 0.972 | 0.324 | ||
| the effective rate | 12(22.2%) | 12(21.4%) | 0.010 | 0.920 | ||
| total effective rate | 33(61.0%) | 39(69.6%) | 0.885 | 0.347 | ||
| ineffective rate | 19(35.2%) | 15(26.8%) | 0.908 | 0.341 | ||
| deterioration rate | 2(3.8%) | 2（3.6%） | / | 1.000 | ||
Abbreviations: DCB = drug-coated balloon; nSFA = superficial femoral artery nonrevas cularization.
a
Non-normally distributed data were described as medians (quartiles). The qualitative data were described as counts (percentage).