Boston Scientific’s Ranger DCB for SFA Treatment Evaluated in 2-Year Data

October 5, 2021—Boston Scientific announced the presentation of findings confirming the safety and efficacy of the company’s Ranger drug-coated balloon (DCB) compared to standard percutaneous transluminal angioplasty (PTA) for the treatment of patients with peripheral artery disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery.

The 2-year results from the RANGER II SFA randomized controlled trial were presented during a late-breaking clinical trial presentation at VIVA 2021, the annual Vascular Interventional Advances meeting held October 4-7 in Las Vegas, Nevada.

“These 2-year data demonstrate a sustained, high rate of efficacy, including in patients with more complex lesion subtypes, yet another proof point for physicians to consider when determining the best individualized treatment option for their patients with PAD,” commented Ravish Sachar, MD, in Boston Scientific’s press release. Dr. Sachar, who is Physician-in-Chief for the heart and vascular services at UNC Rex Hospital in Raleigh, North Carolina, serves as Principal Investigator of the RANGER II SFA trial.

The presentation follows the positive 1-year results of RANGER II SFA, which were published by Dr. Sachar et al in Journal of the American College of Cardiology: Cardiovascular Interventions (2021;14:1123-1133).

Results from the RANGER II SFA pivotal trial supported FDA approval of the Ranger DCB, which Boston Scientific announced in November 2020.

According to Boston Scientific, the new results presented at VIVA 2021 showed favorable comparisons for the Ranger DCB, which has a low drug dose density of paclitaxel, versus standard PTA, including the following:

• A significantly higher 2-year primary patency rate compared to standard PTA (84% vs 71.4%; P = .0129)
• In subgroup analyses, greater long-term patency in patients with more complex lesions in the moderate-to-severe calcium subgroup (89.1% vs 72.4%; P = .0052) and a greater primary patency rate in patients with chronic total occlusions (76.6% vs 58.6%; P = .1038)
• Significant reduction in reinterventions at 2 years, with a freedom from target lesion revascularization of 87.4% vs 79.5% (P = .0316)
• No significant difference in all-cause mortality (5.7% vs 3.2%; P = .4218)