Safety and efficacy of paclitaxel drug-coated balloon treatment of femoropopliteal claudicants: Data and analytic methods matter.

Claudicants with femoropopliteal disease average 25% higher primary patency and reduced target lesion revascularization long term with crystalline paclitaxel eluting stent and balloon treatment compared to uncoated devices. In animal models, local and downstream tissues have detectable paclitaxel for greater than 180 days. Aggregate data meta-analyses of 28 randomized trials suggested 50-100% higher all-cause mortality with paclitaxel device treatment. In contrast, more complete ascertainment of follow-up and pooled individual patient data analyses do not find significantly increased mortality, a dose-mortality relationship, or an unexpected cause of death pattern with paclitaxel eluting device treatment in femoropopliteal claudicants.