1-Year Results From the RANGER II SFA Randomized Trial of the Ranger Drug-Coated Balloon.

Abstract

This study sought to evaluate the safety and effectiveness of the Ranger drug-coated balloon (DCB) (paclitaxel dose density 2μg/mm2) for treating superficial femoral artery or proximal popliteal artery lesions. Paclitaxel-coated balloon treatment prevents reinterventions, but dose and coating characteristics differ among balloons and necessitate discrete confirmation of safety and effectiveness. Patients with symptomatic lower limb ischemia (Rutherford classification 2 to 4) were randomized 3:1 to treatment with the Ranger DCB or standard percutaneous transluminal angioplasty (PTA). Twelve-month primary target lesion patency, freedom from major adverse events (i.e., target lesion revascularization, major amputations, death within 1month of the index procedure), and patient outcomes were analyzed. Mean lesion length was 82.5 ± 48.9mm for the Ranger DCB group (n=278) and 79.9 ± 49.3mm for the control group (n=98). Ranger DCB was superior to PTA (82.9% [n=194 of 234] vs. 66.3% [n=57 of 86]) with observed 12-month primary patency rates yielding a difference of 16.6% (95% confidence interval: 5.5% to 27.7%; p=0.0013). Noninferior freedom from major adverse events (94.1% [n=241 of 256] vs. 83.5% [n=76 of 91]) was demonstrated with a difference of 10.6% (95% confidence interval: 2.5% to 18.8%; noninferiority p<0.0001). Primary patency rate curves showed significant separation by Kaplan-Meier analysis (log-rank p=0.0005), with rates of 89.8% and 74.0% estimated at day 365 for the Ranger DCB and PTA cohorts, respectively. The low-dose Ranger DCB demonstrated significantly better effectiveness than standard PTA through 1 year and a good safety profile. (Ranger™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty [RANGER II SFA]; NCT03064126).