Gray WA, Jaff MR, Parikh SA, et al. - Because excess late mortality in the paclitaxel-treated patients has been reported in a recent summary-level meta-analysis of randomized, controlled trials (RCTs) of femoropopliteal paclitaxel-coated balloon and stent intervention, researchers analyzed patient-level data from all patients in the Stellarex femoropopliteal clinical program in an independently conducted meta-analysis in order to assess if Stellarex drug-coated balloon (DCB) is safe for femoropopliteal artery disease. They analyzed data from 2 RCTs, including 419 and 170 patients treated with DCB and percutaneous transluminal angioplasty (PTA), respectively, to compare mortality following DCB or uncoated PTA. From 6 poolable Stellarex DCB studies (2 RCTs, 3 single-arm studies, and 1 registry), data were obtained and analyzed in an additional analysis. Three years of follow-up revealed indistinguishable mortality rates between patients treated with the DCB and uncoated PTA. Age, diabetes mellitus, congestive heart failure, and renal insufficiency were identified as mortality predictors via multivariable Cox modeling.