Background: Atherosclerotic peripheral artery disease (PAD) is common and results in limitations in quality of life and potential progression to limb loss. Options for therapy include medical therapy, supervised exercise, surgical revascularization, and more recently, endovascular therapies to restore arterial perfusion to the limb. Endovascular revascularization has evolved over the past two decades, from percutaneous transluminal angioplasty (PTA) to self-expanding stents, atherectomy, laser angioplasty, and drug eluting stents. Despite impressive technologic advances, PTA remains the standard of care at many institutions and is the recommended primary treatment modality for femoral-popliteal PAD according to current ACCF/AHA guidelines. However, restenosis after PTA is common. Therefore, a significant clinical need remains for a device that is able to achieve more durable patency than PTA but does not require a permanent implant.
A C C E P T E D M A N U S C R I P T ACCEPTED MANUSCRIPT3 PAD designed to demonstrate superior efficacy and non-inferior safety of a novel paclitaxel DCB compared to PTA. The primary efficacy endpoint is primary patency at 12 months. The primary safety endpoint is composite freedom at 12 months from perioperative death, index limb amputation, re-intervention, and limb-related mortality. A series of important secondary endpoints include physical functioning, quality of life, revascularizations, and alternative measures of patency. In order to minimize bias potential for confounding variables, LEVANT 2:(1) excluded patients stented after predilation prior to randomization;(2) incorporated very stringent criteria for bailout stenting; Conclusions: LEVANT 2 represents the first US-inclusive multicenter, randomized, controlled trial to assess the safety and efficacy of a novel drug coated balloon (DCB) compared to PTA as primary therapy for symptomatic PAD on the background of standard medical therapy.