Table 2

Safety and efficacy endpoints

DCB group (n=32)CB group (n=32)OR (95% Cl)P value
Primary safety endpoint within 30 days
 Any stroke or death1 (3.1)2 (6.3)0.484
(0.042 to 5.621)
1
 Ischemic stroke1 (3.1)0NA1
 ICH, SAH, or IVH02 (6.3)NA0.492
 Death01 (3.1)NA1
Secondary safety endpoints from 31 days to 1 year
 Ischemic stroke1
 In target vessel territory2 (6.3)3 (9.5)0.644
(0.100 to 4.142)
0.349
 In other vessel territories1 (3.1)1 (3.1)1.909
(0.114 to 32.009)
1
 TIA2 (6.3)1 (3.1)2.067
(0.178 to 24.006)
1
 ICH, SAH, or IVH00NA1
 All-cause death01 (3.1)NA1
Primary efficacy endpoint
 Restenosis2 (6.3)10 (31.3)0.147
(0.029 to 0.737)
0.010
Secondary efficacy endpoints
 Technical success30 (93.8)28 (87.5)2.143
(0.364 to 12.628)
0.668
 Symptomatic restenosis1 (3.1)4 (12.5)0.226
(0.024 to 2.143)
0.352
 Stenosis degree at follow-up23 (18.75)31 (30)NA0.013
 mRS score at 1 year0 (1)0 (1)NA0.869
  • 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.