Periprocedural safety and postprocedural outcomes
| DEB group (n=29) | Conventional group (n=36) | P value | |
| Periprocedural neurological complications* (within 1 month after PTAS) | 1 (3.4%)† | 0 | 0.197 |
| Early postprocedural MRI within 24 hours after PTAS | |||
| Numbers of REIL‡ | 1.0±2.1 (0–8) | 1.3±1.5 (0–7) | 0.592 |
| Ultrasonography 6 months after PTAS (short-term outcome) | |||
| PSV (cm/s) | 81.95±31.35 (26.3–185.2) | 104.13±42.76 (50.1–301.2) | 0.023 |
| CTA/MRI 12 months after PTAS (long-term outcome) | |||
| Operation to delayed CTA/MRI time (days) | 364±6 (346-376) | 363±5 (340-370) | 0.264 |
| Delayed in-stent restenosis (%) | 26.58±8.75 (8.8–51.0) | 45.93±20.86 (17.1–97.4) | < 0.001 |
| Significant in-stent restenosis (≥50%) | 1 (3.4%) | 8 (22.2%) | 0.029 |
Results are shown as number (%) or mean±SD (range).
*Neurological complications within 1 month after PTAS were referred to amaurosis, transient ischemic attack, or minor or major stroke.
†This subject experienced transient ischemic attack at 23 days after PTAS. Although the exact causes of this event were difficult to investigate, this event was counted as periprocedural neurological complications based on the common definitions (neurological events within 30 days after procedures).
‡REIL was defined as restricted diffusion in the treated vascular territory of the brain parenchyma.
CTA, CT angiography; DEB, drug-eluting balloon; PSV, peak systolic velocity; PTAS, percutaneous angioplasty and stenting ; REIL, recent embolin ischemic lesion .