Background Drug coated balloon (DCB) angioplasty can provide sustained anti-restenotic efficacy without the limitations of permanent vascular implantation and is presumably ideal for treating intracranial atherosclerotic disease. However, the safety of paclitaxel in the neurovasculature remains a concern.

Methods 242 patients with angiographically verified symptomatic stenosis >70% in intracranial arteries treated with DCB angioplasty were reviewed divided into two groups: group A, patients with stenotic intracranial arteries; and group B, patients with acute, subacute, or chronic occluded intracranial arteries. The primary endpoint was any stroke or death within 30 days. The secondary endpoint was arterial restenosis of >50% during follow-up.

Results 16 major and 12 minor complications occurred among 245 procedures (6.5% and 4.9%, respectively). Five patients died within 30 days after the procedure (2.1%, 5/242). 12 major and 12 minor complications occurred among 211 procedures in group A (5.7% and 5.7%). In group B, four major complications occurred among 34 procedures (11.8%). Hyperperfusion and perforator stroke accounted for half of all complications (53.6%, 15/28). Restenosis >50% was present in eight lesions during the follow-up period (4.8%, 8/167).

Conclusions After treatment with DCB angioplasty, complications were no different from those after standard balloon angioplasty or stenting. This study suggests that DCB angioplasty may be a safe and effective procedure for intracranial arterial stenosis.