Midterm Outcomes of Drug-Coated Balloon Angioplasty in Femoropopliteal Lesions in a Daily Practice Cohort

Abstract

Background: Most previous drug-coated balloon (DCB) angioplasty studies used strict inclusion and exclusion criteria and therefore might not be representative for daily practice. This study was performed to evaluate the midterm outcomes of DCB angioplasty in femoropopliteal artery disease and to identify risk factors for restenosis.

Materials and methods: All patients treated with DCB angioplasty between January 2015 and September 2016 were included. Provisional stents were placed if indicated. Data were retrospectively collected from digital patient records. No exclusion criteria were applied. The primary end point was primary patency. Secondary end points were primary assisted patency, secondary patency, clinically driven target lesion revascularization (CD-TLR) and major adverse events. All end points were calculated with the Kaplan-Meier analysis. The univariable and multivariable Cox regression analyses were performed to identify risk factors for restenosis.

Results: A total of 109 patients (113 legs) were included (45% male; mean age, 72 ± 10). The rate of critical limb ischemia was 52% and total occlusions were treated in 38%. The mean follow-up was 24 ± 13 months. Primary patency rates were 87%, 79%, and 61% at 1, 2, and 3 years, respectively. Primary assisted patency rates were 95%; 89%, and 79%; secondary patency rates were 99%, 97%, and 91%; and CD-TLR rates were 6.9%, 14.3%, and 20.6% at 1, 2, and 3 years, respectively. Overall mortality and major target limb amputation rates were 18% and 5% at 3 years. Multivariable analysis demonstrated that only Trans-Atlantic Inter-Society Consensus (TASC) D lesions were associated with restenosis (P = 0.008).

Conclusions: DCB angioplasty is an effective and safe treatment option for femoropopliteal lesions in daily practice with excellent 1- and 2-year results. The 3-year results were slightly less favorable, which may be caused by the ongoing vascular disease or a late "catch-up" phenomenon. Only TASC D lesions were associated with loss of primary patency after adjustment for confounders.