Today, Boston Scientific (NYSE: BSX) announced positive results for the Ranger™ Drug-Coated Balloon (DCB) during a late-breaking clinical trial presentation at the Vascular InterVentional Advances (VIVA) meeting in Las Vegas. The data included two-year results from the RANGER II SFA randomized controlled trial, confirming the safety and efficacy of the Ranger 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 (PPA).
Following the positive one-year results of RANGER II SFA, which were published in the Journal of American College of Cardiology, the new two-year results found that the Ranger DCB exhibited a significantly higher primary patency rate – a measure of the target vessel remaining unobstructed at two years – of 84.0% compared to 71.4% percent in patients treated with standard PTA (p=0.0129).i Additionally, subgroup analyses found consistent benefit with greater long-term patency in patients with more complex lesions treated with the Ranger DCB, exhibiting an 89.1% versus 72.4% primary patency rate in the moderate to severe calcium subgroup (p=0.0052) and a 76.6% compared to a 58.6% primary patency rate in patients with chronic total occlusions (p=0.1038).i
“These two-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,” said Ravish Sachar, M.D., UNC Rex Hospital physician-in-chief for Heart and Vascular services and principal investigator of the RANGER II SFA trial.ii
The Ranger DCB, which has a low drug dose density of paclitaxel, also demonstrated a significant reduction in reinterventions at two years with a freedom from target lesion revascularization (TLR) rate of 87.4% versus 79.5% observed with standard PTA (p=0.0316).i Additionally, there was no significant difference in all-cause mortality with a 5.7% rate for the patients treated with Ranger DCB and 3.2% in patients treated with standard PTA (p=0.4218).
“We’re very pleased to see that the Ranger DCB exhibited excellent, sustained results at two years and it is particularly gratifying that the RANGER II SFA subgroup analyses found no reintervention disadvantage for women, who have historically experienced greater patency challenges following endovascular intervention for PAD,” said Michael R. Jaff, D.O., chief medical officer and vice president clinical affairs, technology and innovation, Peripheral Interventions, Boston Scientific.
Late-breaking results from the EMINENT trial, which evaluated the Eluvia™ Drug-Eluting Stent vs. bare-metal stents, will be presented tomorrow, October 6, at the VIVA21 conference.
i Kaplan Meier Estimate
ii Dr. Ravish Sachar is a paid consultant for Boston Scientific Corporation. He has not been compensated for his quote within this press release.