Drug-Eluting Nitinol Stent Treatment of the Superficial Femoral Artery and Above-the-Knee Popliteal Artery (The Zilver PTX Single-Arm Clinical Study): A Comparison Between Diabetic and Nondiabetic Patients

Purpose To describe the 1-year results of drug-eluting nitinol stent placement in the femoropopliteal artery of diabetic and nondiabetic patients. Materials and Methods All patients enrolled in this prospective, multicenter study underwent paclitaxel-eluting stent placement for de novo or restenotic lesions of the superficial femoral and/or popliteal artery. Baseline and follow-up walking impairment questionnaire (WIQ) scores, Rutherford classifications, and ankle–brachial index (ABI) measurements were obtained. Follow-up was completed at 1, 6, and 12 months. Results There were 285 diabetic patients and 502 nondiabetic patients treated. There were no significant differences in mean lesion length or lesion calcification between patient groups. Procedural success in both treatment groups was >97 %. There were no significant differences between diabetic and nondiabetic groups in Kaplan–Meier estimates of patency, event-free survival (EFS), or freedom from target lesion revascularization (TLR) at 6 and 12 months. Both groups experienced a significant increase in ABI and WIQ values after treatment, and these improvements were sustained to 12-month follow-up; however, nondiabetic patients had significantly greater 6- and 12-month WIQ scores compared with diabetic patients. Based on covariate analysis, the only factors shown to be significant and to negatively influence patency were longer lesion length ( p = 0.009), higher Rutherford classification ( p = 0.02), and lack of hypertension ( p = 0.02); diabetic status was not found to be a significant factor. Conclusion Diabetic and nondiabetic patients had similar estimates of primary patency, EFS, and freedom from TLR; however, diabetic patients showed less improvement in WIQ scores compared with nondiabetic patients.