Six-Month Results From the Initial Randomized Study of the Ranger Paclitaxel-Coated Balloon in the Femoropopliteal Segment

J Endovasc Ther. 2017 Aug;24(4):459-467. doi: 10.1177/1526602817710770. Epub 2017 May 31.

Abstract

Purpose: To evaluate the performance of the Ranger paclitaxel-coated balloon vs uncoated balloon angioplasty for femoropopliteal lesions.

Methods: Between January 2014 and October 2015, the prospective, randomized RANGER SFA study ( ClinicalTrials.gov identifier NCT02013193) enrolled 105 patients with symptomatic lower limb ischemia (Rutherford category 2-4) and stenotic lesions in the nonstented femoropopliteal segment at 10 European centers. Seventy-one patients (mean age 68±8 years; 53 men) were enrolled in the Ranger drug-coated balloon (DCB) arm and 34 patients (mean age 67±9 years; 23 men) were assigned to the control group. Six-month analysis included angiographic late lumen loss and safety and clinical outcomes assessments.

Results: Baseline characteristics of the DCB and control groups were similar, as were lesion lengths (68±46 vs 60±48 mm; p=0.731), severity of calcification (p=0.236), and the prevalence of occlusions (34% vs 34%; p>0.999). At 6 months, late lumen loss was significantly less for the DCB group vs controls (-0.16±0.99 vs 0.76±1.4; p=0.002). The DCB group had significantly greater freedom from binary restenosis (92% vs 64%; p=0.005) and primary patency rates (87% vs 60%; p=0.014). Target lesion revascularization rates were 5.6% in the DCB group and 12% in the control group (p=0.475). No target limb amputations or device-related deaths occurred in either group.

Conclusion: Six-month results suggest that Ranger DCB treatment effectively inhibited restenosis in symptomatic femoropopliteal disease, resulting in improved vessel patency and a low revascularization rate in the short term compared with uncoated balloon angioplasty.

Keywords: drug-coated balloon; drug-eluting balloon; femoropopliteal segment; late lumen loss; paclitaxel; patency; peripheral artery disease; peripheral vascular diseases; popliteal artery; restenosis; stenosis; superficial femoral artery.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Angioplasty, Balloon / adverse effects
  • Angioplasty, Balloon / instrumentation*
  • Cardiovascular Agents / administration & dosage*
  • Cardiovascular Agents / adverse effects
  • Coated Materials, Biocompatible*
  • Equipment Design
  • Europe
  • Female
  • Femoral Artery* / diagnostic imaging
  • Femoral Artery* / physiopathology
  • Humans
  • Male
  • Middle Aged
  • Paclitaxel / administration & dosage*
  • Paclitaxel / adverse effects
  • Peripheral Arterial Disease / diagnostic imaging
  • Peripheral Arterial Disease / physiopathology
  • Peripheral Arterial Disease / therapy*
  • Popliteal Artery* / diagnostic imaging
  • Popliteal Artery* / physiopathology
  • Prospective Studies
  • Recurrence
  • Time Factors
  • Treatment Outcome
  • Vascular Access Devices*
  • Vascular Patency

Substances

  • Cardiovascular Agents
  • Coated Materials, Biocompatible
  • Paclitaxel

Associated data

  • ClinicalTrials.gov/NCT02013193