Twelve-Month Results of Zilver PTX in Long Femoropopliteal Lesions Presented at LINC

January 29, 2014—At LINC 2014: The Leipzig Interventional Course in Leipzig, Germany, Prof. Thomas Zeller, MD, presented the 12-month results of a postmarket study evaluating the Zilver PTX paclitaxel-eluting stent (Cook Medical, Bloomington, IN) in long lesions. The study looked at safety, device integrity, and primary patency in 45 patients with single-segment lesions ≥ 80 mm and ≤ 280 mm in length. 

Study subjects included patients with de novo or restenotic lesions with > 50% diameter stenosis, Rutherford classification ≥ 2, and reference vessel diameter of 4 to 9 mm; in-stent restenosis was not included. Lesion length as assessed by angiographic core lab was 189.3 ± 91.1 mm; percent diameter stenosis was 95.4 ± 11.1. Total occlusions were noted in 82.2% of lesions, and 97.8% were de novo. Severe calcification was present in 40%. 

Prof. Zeller reported that there was no procedure- or device-related mortality, and the event-free survival rate (defined as freedom from death, amputation, target lesion revascularization, and worsening Rutherford classification) was 86.1%. There were no stent fractures detected by the core lab at 12 months (0/93). Primary patency by Kaplan-Meier estimate (PSVR < 2.0) was 86.1%. These results are in line with what has been previously published and presented from studies including patients in similar cohorts treated with Zilver PTX, noted Prof. Zeller.