Drug-Coated Balloon Angioplasty for de Novo Subclavian Artery Stenosis: Mid-Term Outcomes and Independent Risk Factors for Restenosis.

BACKGROUND

Endovascular intervention is the first-line treatment for subclavian artery stenosis, but high-quality evidence for drug-coated balloon (DCB) angioplasty specifically in de novo lesions remains limited. This study aimed to evaluate the safety and efficacy of DCB for de novo subclavian artery stenosis and to identify independent risk factors for restenosis.

METHODS

This single-center retrospective cohort study enrolled 53 consecutive patients with de novo subclavian artery stenosis (≥70% confirmed by quantitative coronary angiography, QCA) treated with a paclitaxel-coated balloon (3.0 μg/mm2; Orchid®, Acotec, Beijing, China) between January 2020 and September 2025. The primary endpoint was 24-month primary patency. Secondary endpoints included technical success, residual stenosis, clinically driven target lesion revascularization (CD-TLR), and major adverse cardiovascular and cerebrovascular events (MACCE). Bailout stenting was required in 35.8% (19/53) of patients due to flow-limiting dissection or significant elastic recoil. Kaplan-Meier survival analysis and Cox proportional hazards regression were performed, with formal assessment of the proportional hazards assumption.

RESULTS

Mean age was 62.7±8.5 years (62.3% male). Technical success rate was 100%, with mean residual stenosis of 11.5±4.9%. Median follow-up was 24 months (IQR 12-36 months, range 6-74 months). Primary patency rates at 12, 24, and 36 months were consistently 94.3% (95% CI 87.6-100%), with all 3 restenosis cases detected at the 12-month CTA follow-up; all were asymptomatic and no CD-TLR was performed. Overall MACCE incidence was 3.8%. Severe lesion calcification (Grade 3) was the only independent risk factor for restenosis on multivariate Cox regression (HR=7.89, 95% CI 1.45-42.96, P=0.017); however, given the small number of events (n=3), these results should be interpreted with caution.

CONCLUSION

DCB angioplasty demonstrates favorable safety and mid-term patency for de novo subclavian artery stenosis in this single-center retrospective cohort. Severe calcification is associated with poorer patency outcomes, though this finding requires validation. These preliminary results suggest DCB as a potential endovascular option for non-severely calcified de novo subclavian lesions; however, the absence of a direct comparator group and the retrospective single-center design limit definitive efficacy conclusions, and prospective comparative studies are needed.