Low-dose Paclitaxel-coated Versus Uncoated Percutaneous Transluminal Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease: 1-year Results of the ILLUMENATE European Randomized Clinical Trial

Numerous studies have reported favorable outcomes using drug-coated balloons (DCBs) for treatment of symptomatic peripheral artery disease (PAD) of the superficial femoral and popliteal arteries. However, the treatment effect compared to an uncoated balloon has differed greatly amongst the randomized trials with better outcomes observed with higher-dose DCBs. This European trial was designed to assess the safety and effectiveness of a next-generation low dose (2 µg/mm2 surface dose of paclitaxel) DCB. This was a prospective, randomized, multi-center, single-blinded trial. Patients were randomized (3:1) to treatment with a low-dose DCB or an uncoated percutaneous transluminal angioplasty (PTA) balloon. The primary safety endpoint was a composite of freedom from device- and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization through 12 months post-procedure. The primary effectiveness endpoint was primary patency at 12 months. Patients were randomized to treatment with a DCB (222 patients, 254 lesions) or uncoated PTA balloon (72 patients, 79 lesions) following successful pre-dilatation. Mean lesion length was 7.2 cm and 7.1 cm, and 19.2% and 19.0% of lesions represented total occlusions, respectively. The primary safety endpoint was met and superiority was demonstrated; freedom from a primary safety event was 94.1% (193/205) with DCB and 83.3% (50/60) with PTA, for a difference of 10.8% (95% CI: 0.9%—23.0%). The primary effectiveness endpoint was met and superiority of DCB over PTA was achieved [83.9% (188/224) vs. 60.6% (40/66), p<0.001]. Outcomes with DCB were also superior to PTA per Kaplan Meier estimate for primary patency (89.0% vs. 65.0% at 365 days, log rank p<0.001) and for rates of clinically-driven target lesion revascularization (5.9% vs 16.7%, p=0.014). Superiority with a low dose DCB for femoropopliteal interventions was demonstrated over PTA for both the safety and effectiveness endpoints. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01858363 Circulation is published on behalf of the American Heart Association, Inc., by Wolters Kluwer Health, Inc. This is an open access article under the terms of the Creative Commons Attribution Non-Commercial-NoDerivs License, which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited, the use is noncommercial, and no modifications or adaptations are made.