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

Abstract

Objectives: This study sought to evaluate the safety and effectiveness of the Ranger drug-coated balloon (DCB) (paclitaxel dose density 2 μg/mm2) for treating superficial femoral artery or proximal popliteal artery lesions.

Background: Paclitaxel-coated balloon treatment prevents reinterventions, but dose and coating characteristics differ among balloons and necessitate discrete confirmation of safety and effectiveness.

Methods: 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 1 month of the index procedure), and patient outcomes were analyzed.

Results: Mean lesion length was 82.5 ± 48.9 mm for the Ranger DCB group (n = 278) and 79.9 ± 49.3 mm 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.

Conclusions: 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).

Keywords: drug-coated balloon; paclitaxel; peripheral arterial disease; superficial femoral artery; vascular patency.

Conflict of interest statement

Funding Support and Author Disclosures The RANGER II SFA trial was funded by Boston Scientific. Dr. Sachar has served in the last 24 months as a consultant, advisory board member for, and received compensation for, educational programs from Boston Scientific and Medtronic; has received funds for research or clinical trials from Abbott Vascular, Bard Peripheral Vascular, Cook Medical, W.L. Gore and Associates, Medtronic, Terumo, and Veryan; and is a major shareholder of Contego Medical. Drs. Soga and Lopez have served as advisors to Boston Scientific. Dr. Ansari has served as an advisory board member for Boston Scientific, Medtronic, and Cordis; served as a steering committee member for Philips; received compensation for educational programs from Edwards, Gore, Bard, and Boston Scientific; and received funds for research or clinical trials from Abbott, Boston Scientific, and Bard. Dr. Brodmann has received honoraria from Abbott Vascular, Biotronik, Boston Scientific, Cook Medical, Medtronic, Philips-Spectranetics, and Shockwave; and served as a consultant for Boston Scientific, Cook Medical, Medtronic, Spectranetics, Intact Vascular, Shockwave, and Cagent. Dr. Schroë has served in the last 24 months as a consultant and advisory board member for Philips; received compensation for educational programs from Abbott and Boston Scientific; and has served as a consultant for Abbott, Bard, B. Braun, Biotronik, Cook Medical, Medtronic, and Philips. Dr. Ramanath has received honoraria from Shockwave Medical, Cardiovascular Systems, and Boston Scientific; and has received compensation for educational programs from Boston Scientific and Terumo Medical. Dr. Diaz-Cartelle is an employee of and owns stock in Boston Scientific. Dr. Zeller has received honoraria from Abbott Vascular, Veryan, Biotronik, Boston Scientific, Cook Medical, W.L. Gore and Associates, Medtronic, Philips-Spectranetics, TriReme, Veryan, Shockwave, Biotronik, B. Braun, and Efemoral; has served as a consultant for Boston Scientific, Cook Medical, W.L. Gore and Associates, Medtronic, Spectranetics, Veryan, Intact Vascular, and Veryan; and owns common stock in QT Medical. Dr. Kozuki has reported that she has no relationships relevant to the contents of this paper to disclose.

Copyright © 2021. Published by Elsevier Inc.