Table 2. Angiographic outcomes up to nine months from the IN.PACT BTK randomised study.
| DCB (N=24 lesions*) | PTA (N=29 lesions*) | Difference [95% CI] | p-value | |
|---|---|---|---|---|
| Classic analysis | ||||
| LLL, mm◊ | 0.892±0.774 (20) | 1.312±0.720 (24) | –0.420 [–0.875, 0.035] | 0.070 |
| MLD, mm | 0.949±0.835 (20) | 0.498±0.597 (24) | 0.451 [0.014, 0.887] | 0.056 |
| Acute lumen gain, mm‡ | 1.881±0.431 (24) | 1.707±0.518 (29) | 0.174 [–0.092, 0.441] | 0.367 |
| Loss index§ | 0.534±0.482 (20) | 0.755±0.332 (24) | –0.222 [–0.470, 0.027] | 0.116 |
| Diameter stenosis, % | 67.827±27.984 (20) | 80.547±22.920 (24) | –12.720 [–28.201, 2.761] | 0.130 |
| Binary restenosis (≥50%), % | 70.0 (14/20) | 83.3 (20/24) | –13.3% [–37.4%, 11.3%] | 0.472 |
| Subsegmental analysis | ||||
| LLL, mm◊ | 0.592±0.944 (19) | 1.260±0.810 (24) | –0.668 [–1.209, –0.128] | 0.017 |
| Acute lumen gain, mm‡ | 1.838±0.738 (23) | 1.602±0.575 (29) | 0.236 [–0.130, 0.602] | 0.201 |
| Loss index§ | 0.486±0.726 (19) | 0.786±0.417 (24) | –0.300 [–0.683, 0.084] | 0.030 |
| Number of subsegments with ≥50% stenosis | 2.800±3.286 (20) | 5.250±3.721 (24) | –2.450 [–4.608, –0.292] | 0.036 |
| Number of occluded subsegments (100% stenosis) | 1.900±3.227 (20) | 3.292±3.557 (24) | –1.392 [–3.476, 0.693] | 0.150 |
| Values are mean±SD (N) or % (n/N). *Core laboratory analysis determined a total of 24 target lesions in the DCB group and 29 target lesions in the PTA group. All core laboratory-based assessments use these values for counts and proportions. ◊Late lumen loss is defined as the difference between MLD at 9 months post procedure and MLD immediately post procedure. ‡Acute lumen gain is defined as the difference between MLD immediately post procedure and MLD at baseline. § Loss index is defined as LLL divided by acute lumen gain. CI: confidence interval; DCB: drug-coated balloon; LLL: late lumen loss; MLD: minimal lumen diameter; PTA: percutaneous transluminal angioplasty | ||||