Paclitaxel-based devices in subintimal versus intraluminal angioplasty for chronic total occlusion of the femoropopliteal artery

<h2>Abstract</h2><h3>Objective</h3> Chronic total occlusion (CTO) of the femoropopliteal artery lesion is a common manifestation of symptomatic lower limb atherosclerosis. However, femoropopliteal chronic total occlusion (FP-CTO) lesions remain a major challenge in endovascular treatment (EVT). Although drug-coated balloons and drug-eluting stents have demonstrated superior outcomes compared with plain old balloon angioplasty and bare nitinol stents in treating femoropopliteal lesions, the optimal strategy for subintimal approaches in FP-CTO remains unclear. <h3>Methods</h3> We retrospectively analyzed 62 patients with FP-CTO who underwent EVT using paclitaxel-based devices (drug-eluting stent or drug-coated balloon) at our institution. Patients were assigned to subintimal (n = 15) or intraluminal (n = 47) groups. At 18 months, the primary end point was freedom from clinically driven target lesion revascularization (CD-TLR), and secondary end points included freedom from reocclusion and the composite of CD-TLR and reocclusion. <h3>Results</h3> At 18 months, freedom from CD-TLR was higher in the intraluminal group than in the subintimal group (76.6% vs 53.3%, <i>P</i> = .045). Freedom from reocclusion was also higher in the intraluminal group (87.2% vs 53.3%, <i>P</i> = .003) than in the subintimal group. In multivariable Cox proportional hazards analysis, the subintimal approach and lesion length were independent risk factors for CD-TLR. <h3>Conclusions</h3> In EVT for FP-CTO, intraluminal paclitaxel-based device therapy was superior to subintimal therapy, with significantly higher rates of freedom from retreatment.