Drug-coated balloon for vertebral artery origin stenosis: a pilot study

BackgroundDrug-coated balloon (DCB) is a potential treatment for patients with low restenosis risk in vertebral artery origin stenosis (VAOS). However, the clinical data of long-term outcome are limited.ObjectiveTo evaluate the safety and efficacy of a DCB in patients with severe VAOS.MethodsA prospective, non-randomized, single-center pilot study enrolled 30 patients with severe VAOS treated with DCB between 2017 and 2018. The first 20 patients were treated with a balloon-to-vessel ratio of predilation (pBVR)＜0.8 (small-size balloon predilation) and the following 10 patients were treated with a pBVR 0.8–1.0 (large-size balloon predilation). Primary safety endpoints included 30-day death, stroke, and transient ischemic attack (TIA). The main efficacy outcome was restenosis at 6 months, defined as a peak systolic velocity >140 cm/s measured by Doppler ultrasound. Long-term outcomes, including TIAs, stroke, death, and modified Rankin Scale score, were followed up to 2 years.ResultsTechnical success (ConclusionThis pilot study suggests that DCB is a safe approach for VAOS. The relatively low restenosis rate indicates the its potential long-term efficacy for VAOS. Future randomized controlled trials to confirm its efficacy are warranted.