Drug-coated balloon versus conventional balloon for stent angioplasty in symptomatic intracranial atherosclerotic stenosis

Background Due to limited evidence on the optimal strategy for intracranial atherosclerotic stenosis (ICAS), further evidence on the safety and efficacy of drug-coated balloon (DCB) predilation stent angioplasty was aimed to be provided. Methods Consecutive patients with symptomatic medically refractory ICAS from January 2016 to November 2022 who underwent balloon predilation stent angioplasty were retrospectively analyzed and dichotomized by whether DCB or conventional balloon (CB) was used. The efficacy and safety endpoints were compared by propensity score matching. Results A total of 95 patients in the DCB group and 100 patients in the CB group were selected. Of these, 134 patients were matched. The in-stent restenosis (ISR) incidence (1.5% vs. 16.4%, p = 0.006) and the median (IQR) stenosis degree at follow-up in the DCB group were significantly lower than those in the CB group [0(0) vs. 0(0), p = 0.031]. The primary safety endpoint within 30 days and secondary safety endpoints from 31 days to 1 year were not statistically different between the two groups. Conclusion Compared with CB predilation stent angioplasty, DCB predilation stent angioplasty effectively reduced the degree of restenosis and the risk of ISR, but had no advantage in terms of symptomatic restenosis risk currently. However, these findings should be interpreted cautiously because of the aforementioned limitations, and prospective multicenter randomized studies with larger patient number will be required to establish the efficacy and safety of DCB.