Background Drug-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.
Objective To evaluate the safety and efficacy of a DCB in patients with severe VAOS.
Methods A 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.
Results Technical success (<50% residual stenosis) was achieved in 26 patients (mean age 66.2±7.0; seven women). Four patients received bailout stenting and were excluded. Ultrasound confirmed restenosis at 6 months in 10 (38.5%) of 26, which was significantly less frequent in LSBP (LSBP vs SSBP=10% vs 56.3%, p<0.05). No adverse events occurred within 30 days of treatment. 19 patients were followed up for 2 years, with two deaths due to cancer.
Conclusion This 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.
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Contributors YW is the principal investigator, and initiated the study. YF was involved in the study design and drafted this manuscript. YM, PG, JC, YC, BY, and LJ were involved in the conception and study design. TW made important statistical contributions. All authors provided feedback on drafts of this paper and read and approved the final manuscript.
Funding This work was supported by the National Key Research and Development Project (2016YFC1301703) and the Beijing Scientific and Technologic Project (Z201100005520020)
Competing interests None declared.
Patient consent for publication Obtained.
Ethics approval This study has confirmed with the declaration of Helsinki and has been reviewed and approved by the medical ethics committee of Xuanwu Hospital, Capital Medical University (010.). All patients and/or their proxies will be asked to sign a written informed consent form.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.
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