Treatment of femoropopliteal in-stent restenosis with paclitaxel-eluting stents.

OBJECTIVES This study sought to evaluate the outcomes of drug-eluting stent treatment for femoropopliteal in-stent restenosis (ISR). BACKGROUND ISR after femoropopliteal interventions is an increasing problem. Although the role of drug-eluting stents in the treatment of coronary ISR is well defined, no published studies have examined drug-eluting stents in the treatment of femoropopliteal ISR. METHODS This study examines 108 patients with 119 ISR lesions who were enrolled in the ZILVER-PTX single-arm study, a prospective, multicenter clinical trial of 787 patients. All patients were treated with paclitaxel-eluting nitinol stents. RESULTS Mean patient age was 68.3 ± 9.4 years; 61.1% of patients were men. Mean lesion length was 133.0 ± 91.7 mm; 33.6% of lesions were >150 mm long and 31.1% of lesions were totally occluded. Procedural success was achieved in 98.2% of lesions with 2.1 ± 1.2 stents placed per lesion. Primary patency was 95.7% at 6 months and 78.8% at 1 year. Freedom from target lesion revascularization was 96.2% at 6 months, 81.0% at 1 year, and 60.8% at 2 years. Forty patients experienced major adverse events, exclusively target lesion revascularization. Before treatment, 81.1% of patients had Rutherford scores ≥3; at 2 years, 60.9% of patients had Rutherford scores ≤1. Both ankle brachial index and walking impairment questionnaire scores significantly improved following treatment. The 1-year fracture rate of stents used in ISR lesions was 1.2%. No significant risk factors associated with loss of patency were identified. CONCLUSIONS Treatment of femoropopliteal ISR with paclitaxel-eluting stents results in favorable acute, midterm, and long-term outcomes. (Zilver PTX Global Registry [ZILVER-PTX]; NCT01094678).