• Sabine Steiner, Andrea Willfort-Ehringer, Horst Sievert, Volker Geist, Michael Lichtenberg, Costantino Del Giudice, Antoine Sauguet, Juan Diaz-Cartelle, Claudia Marx, Armin Ströbel, Ingolf Schult, Dierk Scheinert, and RANGER SFA Investigators.
• Universitätsklinikum Leipzig, Leipzig, Germany.
• JACC Cardiovasc Interv. 2018 May 28; 11 (10): 934-941.

ObjectivesThe authors sought to evaluate the performance of the Ranger paclitaxel-coated balloon versus uncoated balloon angioplasty for femoropopliteal lesions at 12 months.BackgroundDrug-coated balloons (DCBs) are a promising endovascular treatment option for peripheral artery disease of the femoropopliteal segment, and each unique device requires dedicated clinical study.MethodsThe prospective, randomized RANGER SFA (Comparison of the Ranger™ Paclitaxel-Coated PTA Balloon Catheter and Uncoated PTA Balloons in Femoropopliteal Arteries) study (NCT02013193) enrolled 105 patients with symptomatic lower limb ischemia (Rutherford category 2 to 4) and stenotic lesions in the nonstented femoropopliteal segment at 10 European centers. Seventy-one patients (mean age 68 ± 8 years, n = 53 men) were enrolled in the Ranger DCB arm, and 34 patients (mean age 67 ± 9 years, n = 23 men) were assigned to the control group. Twelve-month analysis included patency, safety, and clinical outcomes and quality-of-life assessments.ResultsThe DCB group had a greater primary patency rate at 12 months (Kaplan-Meier estimate 86.4% vs. 56.5%), with a significantly longer time to patency failure (log-rank p < 0.001). The estimated freedom from target lesion revascularization rate was 91.2% in the DCB group and 69.9% in the control group at 12 months, with a significantly longer time to reintervention (p = 0.010). No target limb amputations or device-related deaths occurred in either group.ConclusionsTwelve-month results show that patency was maintained longer after Ranger DCB treatment than after conventional balloon angioplasty, and this result was associated with a low revascularization rate and good clinical outcomes.Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

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