LAUSR

Recent developments in the management of peripheral artery disease have been momentous, and a key advance has been the introduction of drug-coated balloons, which capitalise on the mechanical effects of angioplasty balloons, and on the pharmacologic effects of anti-restenotic drugs [ 1 , 2 ]. Indeed, single reports from randomized trials and pooled estimates from meta-analyses have clearly showed that paclitaxel-coated balloons reduce the risk of restenosis and repeat revascularization, while improving patency, limb salvage, and freedom from claudication [ 3 , 4 ]. A bomb was however dropped in the endovascular arena in late 2018 by Katsanos and colleagues, who pooled available trials on paclitaxel-coated balloons and paclitaxel-eluting stents for endovascular therapy, and strongly hinted at an increased risk of death when using these devices [5] . A heated debate has followed suite, with device companies updating previous reports from controlled studies of drug-coated devices, further weakening the case in favor of paclitaxel, and the US Food and Drug Administration convening a panel of experts and recommending caution when considering the use of these devices [6] .