RANGER II SFA trial of Ranger Drug-Coated Balloon shows safety and efficacy for peripheral artery disease.
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). 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).
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). 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).
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