Abstract 13533: 1-Year Results of Paclitaxel-Coating Nitinol Stent Placement for Chronic Total Occlusion in the Femoropopliteal Artey

Abstract

Introduction: The mid-term outcomes of paclitaxel-coating nitinol stent (Zilver PTx) placement for chronic total occlusion (CTO) in the femoropopliteal artery have not been assessed. Hypothesis: Zilver PTx placement for CTO in the femoropopliteal artey is reliable. Methods: All patients enrolled in this prospective, single center study underwent Zilver PTx placement for de novo or restenotic CTO and non-CTO in the superficial femoral and/or popliteal artery. Baseline and follow-up Rutherford classification and Ankle-brachial index (ABI) measurements were obtained. Follow-up was completed at 3, 6, 12 months. Results: There were 61 of CTO and 58 of non-CTO treated. Mean age was 74 ± 8 years and male was 82 % in overall. Patients characteristics and degree of lesion calcification was not different significantly between two groups. CTO group had a longer mean lesion length than non-CTO group (209 mm ± 93 mm vs 131 mm ± 87 mm, P < .0001). Procedural success in both treatments was over 98 %. The operative complications were 3 cases in CTO group and 2 cases in non-CTO group. The primary patency of CTO group was significantly lower than non-CTO group in Kaplan-Meier estimate curves at 12 months (75 % vs 82 %, Log-rank P < 0.05). There were no significant differences in event-free survival or freedom from target lesion revascularization in Kaplan-Meier estimate curves at 12 months (68 % vs 70 %; Log-rank P = 0.82, 63 % vs 65 %; Log-rank P = 0.47, respectively). Both groups experienced a significant improvement in Rutherford classification and ABI after treatment, and these improvements were sustained to 12-months follow-up. Based on multivariate analysis, CTO was the negative predictor for primary patency at 12 months (HR 2.37, 95 % CI 1.02 to 5.9, adjusted P < 0.05). Conclusions: CTO influences negatively the primary patency of Zilver PTx placed in the femoropopliteal artery. However, Improvement of Rutherford classification and ABI at 12-months after CTO- intervention is sustained.