Why is this study important?  

Paclitaxel-coated peripheral devices were considered the standard of care when treating PAD patients due to the decreased need for revascularization, a common risk of peripheral vascular intervention. A meta-analysis in 2018 found that paclitaxel-coated peripheral devices were associated with increased mortality, drawing into question the safety of the devices. The SAFE-PAD study was created in collaboration with the U.S. Food & Drug Administration to evaluate the long-term safety of paclitaxel-coated devices compared with non-paclitaxel-coated devices for femoropopliteal artery revascularization among a broad, real-world population of patients with PAD. 

What question was the study supposed to answer? 

Long-term safety of DCB in patients with peripheral arterial disease.  

What did the study show?  

This update reflects long-term data from the SAFE-PAD study and found no meaningful difference in mortality between patients treated with a paclitaxel drug-coated device (DCD) and those treated with a non-drug coated device (NDCD) for up to six years after the index procedure, regardless of the patient’s mortality risk and device type. In this report from SAFE-PAD, there remained no evidence of harm associated with DCDs. The findings were robust in sensitivity analyses and consistent across all subgroups, in particular those at the lowest risk of mortality.