Paclitaxel drug-coated balloons and drug-eluting stents became commercially available for the treatment of intermittent claudication in 2015 and 2012, respectively. Both devices demonstrated superiority in limb revascularization compared with non-paclitaxel-coated devices and were rapidly accepted into clinical practice. In a recent systematic review and study-level meta-analysis, Katsanos et al reported a late all-cause mortality signal for patients in the drug-coated balloon and drug-eluting stent arms of randomized clinical trials for both devices. As a result of this safety signal, Vascular InterVentional Advances Physicians (VIVA), a not-for-profit 501c(3) organization, convened the Vascular Leaders Forum on March 1 and 2, 2019, in Washington, DC, to initiate an open and collaborative process of investigation into this finding. The Vascular Leaders Forum brought together 100 stakeholders, including 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 reviewed the natural history of peripheral arterial disease, the use of paclitaxel in peripheral arterial disease and other conditions, the harm signal noted by Katsanos et al, the impact of the methods chosen by Katsanos et al, possible 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. This document integrates the most current data to help establish an appropriate path forward to understand the risks and benefits associated with these technologies while ensuring the best treatment paradigm for patients.
