Data from a large real-world study do not support an earlier signal of increased mortality risk with the use of paclitaxel-coated balloons and stents in treatment of peripheral artery disease, researchers say.

Initial findings suggest that the drug-coated devices (DCDs) are not inferior to nondrug-coated devices (NDCDs) in patients receiving femoropopliteal-artery revascularisation.

The SAFE-PAD (Safety Assessment of Femoropopliteal Endovascular Treatment with Paclitaxel-Coated Devices) study was designed, with input from the FDA in the US, to provide longitudinal data on the issue.

Its first report was presented at the virtual annual meeting of the American College of Cardiology last week and published simultaneously in JAMA Internal Medicine.