Primary Patency of Long-Segment Femoropopliteal Artery Lesions in Patients with Peripheral Arterial Occlusive Disease Treated with Paclitaxel-Eluting Technology

Background: The aim of this study is to evaluate the performance and predictors of failure of paclitaxel drug-eluting stents and paclitaxel-coated balloons in the treatment of long-segment femoropopliteal disease. We report a retrospective cohort analysis of patients treated with paclitaxel-eluting stents and paclitaxel-coated balloons in lesions >100 mm, which were not included in any of the pivotal trials. Methods: Ninety-seven patients with peripheral vascular disease (Rutherford III–VI) underwent long-segment (≥100 mm) femoropopliteal drug-eluting stent (DES) implantation or angioplasty with drug-coated balloons (DCB). Patients were followed after their initial procedure for target lesion restenosis, defined as a reduction in lumen diameter by greater than 50% as measured by duplex ultrasonography (ratio >2). Results: The median length of the affected arterial segments was 110 mm (interquartile range [IQR] 100–150, absolute range 100–260) using up to 4 overlapping stents. During the median 13-month follow-up (IQR 7–16), no early thrombotic occlusions occurred within 30 days, but 28 (29%) patients developed a target lesion restenosis after 1 year. Cumulative primary patency at 6 and 12 months was 87% and 71% overall, respectively. The cumulative patency during the same follow-up periods varied between patients treated with different paclitaxel modalities with 88% and 80% primary patency in patients treated with DES (n = 63) versus 81% and 49% in patients treated with DCB (n = 21) (adjusted hazard ratio 2.46, P = 0.03). Lesion length, concurrent tibial intervention, and recurrent target lesions were not associated with restenosis. Conclusions: Short-term outcomes in patients treated with paclitaxel-eluting stents and paclitaxel-coated balloons in long lesions, mirror results from the clinical trials. The primary patency observed in patients treated with DES was significantly higher than in patients treated with DCB.