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J Endovasc Ther. 2016 Jun;23(3):417-23. doi: 10.1177/1526602816645080. Epub 2016 Apr 20.

Single-Center Experience With Lutonix Drug-Coated Balloons in Infrapopliteal Arteries.

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Department of Interventional Angiology, Medical Faculty, University of Leipzig, Germany
Department of Interventional Angiology, Medical Faculty, University of Leipzig, Germany.



To examine patient outcomes following the use of the Lutonix drug-coated balloon (DCB) in patients undergoing endovascular intervention in below-the-knee (BTK) arteries.


A retrospective chart review identified 248 patients who were treated for symptomatic peripheral artery disease with the Lutonix DCB between May 2013 and October 2014. Forty patients were lost to follow-up, leaving 208 patients (mean age 74.1±9.7 years; 138 men) with evaluable data for outcome analysis. The patient cohort suffered from either severe claudication (38.6%) or critical limb ischemia (CLI; 61.4%) in 220 limbs. Almost two-thirds (140, 63.6%) of the 220 target lesions were total occlusions, and 37 (17.8%) of all patients had occlusion of all 3 BTK vessels before intervention.


Over a median 9-month follow-up, target lesion revascularization occurred in 15.9% of patients with an average time to first reintervention of 8 months. In total, 39 amputations were performed in 31 limbs. However, 17 of these amputations were preplanned minor amputations below the ankle; only 9 (4.1%) major amputations occurred corresponding to 6.6% of the CLI cohort. Freedom from the composite of death or major amputation was estimated as 92% and 85% at 6 and 12 months, respectively, by Kaplan-Meier analysis. In the full cohort, improvement of at least 1 Rutherford category was seen in 130 (59.1%) limbs after 1 year or at the last follow-up, with 104 (80.0%) of those limbs showing an improvement of ≥2 categories.


From this single-center experience, the Lutonix DCB shows therapeutic promise in a disease state where new treatment options are needed.


amputation; balloon angioplasty; critical limb ischemia; drug-coated balloon; drug-eluting balloon; infrapopliteal arteries; occlusion; paclitaxel; peripheral vascular disease; restenosis; stenosis

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