Beckman JA, et al. - In view of a recent systematic review and study-level meta-analysis reporting late all-cause mortality signal for patients receiving the drug-coated balloon and patients receiving drug-eluting stent for intermittent claudication in randomized clinical trials, Vascular InterVentional Advances Physicians convened the Vascular Leaders Forum on March 1 and 2, 2019, in Washington, DC, to launch an open and collaborative process of investigation into this finding. Hundred stakeholders were brought together for this work; these included an international group of representatives of cardiovascular medicine, interventional radiology, vascular medicine, and vascular surgery; oncologists; basic scientists; the Food and Drug Administration; the Centers for Medicare and Medicaid Services; and commercial manufacturers of these products. The Vascular Leaders Forum performed review of the natural history of peripheral arterial disease, the use of paclitaxel in peripheral arterial disease and other conditions, the harm signal perceived by Katsanos et al, the influence of the methods chosen by Katsanos et al, likely mechanisms of harm, the role of the Food and Drug Administration in a setting like this one, and guidance for clinicians taking care of patients with symptomatic peripheral arterial disease. In this document, the most recent data have been incorporated to assist in establishing an appropriate path forward to reveal the risks and benefits linked with these technologies while ensuring the best treatment paradigm for patients.