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

Abstract Objective The aim of this study was 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 paclitaxel eluting stent (DES) implantation or angioplasty with paclitaxel 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. Conclusion 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 DCBs.