Outcomes of Adjunctive Drug-Coated Versus Uncoated Balloon after Atherectomy in Femoropopliteal Artery Disease

Abstract

Background: The purpose of this study is to evaluate outcomes using drug-coated balloon (DCB) in comparison with uncoated balloon as adjunctive treatment after atherectomy for femoropopliteal artery lesions.

Methods: This single-center retrospective and prospective study included 115 patients with 126 femoropopliteal artery lesions treated with endovascular treatment using atherectomy. Of these, 58 patients received adjunctive DCB after atherectomy (group A) and 57 patients were managed with uncoated balloon after atherectomy (group B). Immediate and late clinical outcomes were compared.

Results: Baseline clinical and lesion data were comparable between the 2 groups. However, group A included more uses of rotational atherectomy (43.9% vs. 1.7%, P < 0.001) or embolization protection filter (53.0% vs. 6.7%, P = 0.001), and fewer cases requiring provisional stenting (4.5% vs. 18.3%, P = 0.014). Clinical primary patency at 1 year was significantly higher in group A than in group B (76.3% vs. 61.1%, P = 0.039). There was a trend toward higher 1-year target lesion revascularization (TLR)-free survival in group A (89.8% vs. 77.9% at 1 year, P = 0.275) without statistical significance. Proportional hazards regression analysis indicated that age (hazard ratio [HR] 0.94, 95% confidence interval [CI] 0.90-0.99, P = 0.016) and provisional stenting (HR 9.78, 95% CI 2.20-43.46, P = 0.003) were independent factors associated with restenosis after combined treatment with atherectomy and DCB.

Conclusions: In femoropopliteal artery disease, the combination of atherectomy with adjunctive DCB achieved better clinical outcomes in terms of clinical primary patency compared to atherectomy plus uncoated balloon while TLR-free survival may also be improved.