Vessel Patency and Associated Factors of Drug-Coated Balloon for Femoropopliteal Lesion

Abstract

Background Although clinical trials have reported favorable outcomes after drug-coated balloon (DCB) therapy for femoropopliteal lesions, their real-world performance and predictors have not been well evaluated. This study aimed to elucidate 1-year freedom from restenosis and to explore the associated factors after a DCB for femoropopliteal lesions in clinical settings. Methods and Results This multicenter, prospective cohort registered 3165 de novo or restenotic femoropopliteallesions (mean lesion length, 13.5±9.3 cm; chronic total occlusion, 25.9%; severe calcification, 14.6%) that underwent successful DCB (Lutonix [24.2%] and IN.PACT Admiral [75.8%]) treatment between March 2018 and December 2019. Patency was assessed at 12±2 months. The primary outcome measure was 1-year freedom from restenosis and its associated factors. Bailout stenting was performed in 3.5% of patients. The postprocedural slow flow phenomenon was observed in 3.9% of patients. During a median follow-up of 14.2 months, 811 patients experienced restenosis. The Kaplan-Meier estimate of freedom from restenosis was 84.5% at 12 months (79.7% at 14 months). Focal, tandem, diffuse, and occlusive restenosis accounted for 37.4%, 9.8%, 18.9%, and 33.9%, respectively. Freedom from target lesion revascularization was 91.5% at 12 months. Risk factors independently associated with 1-year restenosis were a history of revascularization, smaller distal reference vessel diameter, severe calcification, chronic total occlusion, low-dose DCB, and residual stenosis. Conclusions The 1-year clinical outcomes after DCB use for femoropopliteal lesions in real-world practice was favorable. The additive risk factors were associated with a lower rate of freedom from restenosis.

Keywords: drug‐coated balloon; endovascular therapy; femoropopliteal lesions; peripheral artery disease; restenosis; re‐occlusion; target lesion revascularization.

Figure 1. Freedom from restenosis and TLR.

A, Kaplan–Meier estimates of 1‐year freedom from restenosis and morphology of restenosis. B, Kaplan–Meier estimates of 1‐year freedom from TLR. Dotted lines represent 95% CIs. TLR indicates target lesion revascularization.

Figure 2. Limb salvage, freedom from any reintervention and MALE, and all‐cause mortality.

A, Kaplan–Meier estimates of 1‐year limb salvage. B, Kaplan–Meier estimates of 1‐year freedom from any reintervention. C, Kaplan–Meier estimates of 1‐year freedom from MALE. D, Kaplan–Meier estimates of 1‐year all‐cause mortality. Dotted lines represent 95% CIs. MALE indicates major adverse limb event (major amputation, bypass conversion, and reintervention).

Figure 3. Prediction of 1‐year restenosis risk.

The simple risk score was calculated as the number of accumulated independent risk factors, that is, history of EVT, distal reference vessel diameter <5 mm, severe classification (PACSS classification grade 4), chronic total occlusion, Lutonix use, and residual stenosis (see Table 3). Kaplan–Meier estimates of 1‐year primary patency by the simple risk score. Dotted lines represent 95% CIs. EVT indicates endovascular therapy; and PACSS, peripheral arterial calcium scoring system.