DCB group (n=32) | CB group (n=32) | OR (95% Cl) | P value | |
Primary safety endpoint within 30 days | ||||
Any stroke or death | 1 (3.1) | 2 (6.3) | 0.484 (0.042 to 5.621) | 1 |
Ischemic stroke | 1 (3.1) | 0 | NA | 1 |
ICH, SAH, or IVH | 0 | 2 (6.3) | NA | 0.492 |
Death | 0 | 1 (3.1) | NA | 1 |
Secondary safety endpoints from 31 days to 1 year | ||||
Ischemic stroke | 1 | |||
In target vessel territory | 2 (6.3) | 3 (9.5) | 0.644 (0.100 to 4.142) | 0.349 |
In other vessel territories | 1 (3.1) | 1 (3.1) | 1.909 (0.114 to 32.009) | 1 |
TIA | 2 (6.3) | 1 (3.1) | 2.067 (0.178 to 24.006) | 1 |
ICH, SAH, or IVH | 0 | 0 | NA | 1 |
All-cause death | 0 | 1 (3.1) | NA | 1 |
Primary efficacy endpoint | ||||
Restenosis | 2 (6.3) | 10 (31.3) | 0.147 (0.029 to 0.737) | 0.010 |
Secondary efficacy endpoints | ||||
Technical success | 30 (93.8) | 28 (87.5) | 2.143 (0.364 to 12.628) | 0.668 |
Symptomatic restenosis | 1 (3.1) | 4 (12.5) | 0.226 (0.024 to 2.143) | 0.352 |
Stenosis degree at follow-up | 23 (18.75) | 31 (30) | NA | 0.013 |
mRS score at 1 year | 0 (1) | 0 (1) | NA | 0.869 |
CB, conventional balloon; DCB, drug-coated balloon; ICH, intracerebral hemorrhage; IVH, intraventricular hemorrhage; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale; SAH, subarachnoid hemorrhage; TIA, transient ischemic attack.