Effect of Drug-Coated Balloon Versus Stent Angioplasty in Patients With Symptomatic Intracranial Atherosclerotic Stenosis.

Background And Objectives: Drug-coated balloons (DCBs) have exhibited promising results in coronary and peripheral artery diseases, but conclusive evidence is lacking in intracranial vasculature. We assessed the safety and efficacy of DCBs vs stent angioplasty for symptomatic intracranial atherosclerotic stenosis (sICAS) and initially identified patients who might have benefited most from DCB treatment.

Methods: A single-center, retrospective cohort study was conducted from June 2021 to May 2022 with 154 patients with sICAS divided into 2 treatment groups: a DCB group (with or without remedial stenting, n = 47) and a stent group (n = 107). The treatment outcomes were compared using 1:2 propensity score matching. The primary safety end point was perioperative stroke or mortality, and the primary efficacy end point was the rate of target vessel restenosis at 12 months. The degree of luminal change was analyzed as a subgroup, defined as the difference between the degree of stenosis at follow-up and immediately after intervention.

Results: One hundred eighteen patients were enrolled using propensity score matching, with 43 patients in the DCB group and 75 in the stent group. The incidence of perioperative adverse events was 2.3% in the DCB group and 8.0% in the stent group ( P = .420). At a median follow-up of 12 months, the incidence of restenosis (11.9% [5/43] vs 28.0% [21/75], P = .045) and the median degree of stenosis (30% [20%, 44%] vs 30% [30%, 70%], P = .009, CI [0-0.01, 0.2]) were significantly lower in the DCB group than in the stent group. DCB angioplasty effectively prevented adverse events in the target vessel area and significantly reduced the degree of luminal change in the M1 segment of the middle cerebral artery (0 [0, 15%] vs 10% [0, 50%], P = .016).

Conclusion: DCB angioplasty might be a safe and effective alternative to stent angioplasty to treat sICAS, particularly among patients with M1 segment of the middle cerebral artery stenosis.