RANGER-SFA 12-Month Data Published for Boston Scientific's Ranger DCB

May 9, 2018—Sabine Steiner, MD, et al published 12-month results from the first-in-human RANGER-SFA trial of the Ranger paclitaxel-coated balloon (Boston Scientific Corporation) for the treatment of femoropopliteal arteries compared with uncoated balloon angioplasty. The study is available online in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.

The prospective, randomized RANGER-SFA trial enrolled 105 patients with symptomatic lower limb ischemia (Rutherford classification 2–4) and stenotic lesions in the nonstented femoropopliteal segment at 10 European centers. The Ranger drug-coated balloon (DCB) arm was composed of 71 patients (mean age, 68 ± 8 years; 53 men), and the control group included 34 patients (mean age, 67 ± 9 years; 23 men). The 12-month analysis included patency, safety, and clinical outcomes and quality-of-life assessments.

As summarized in JACC: Cardiovascular Interventions, the DCB group had a greater primary patency rate at 12 months compared with the control group (Kaplan-Meier estimate, 86.4% vs 56.5%) with a significantly longer time to patency failure (log-rank P < .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 = .01). There were no target limb amputations or device-related deaths in either group.

The 12-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, concluded the investigators in JACC: Cardiovascular Interventions.

In April 2017, 12-month data from the RANGER-SFA trial were presented at the 2017 Charing Cross Symposium in London, United Kingdom. Dierk Scheinert, MD, is the Principal Investigator of RANGER-SFA.