Update From the Safety Assessment of Femoropopliteal Endovascular Treatment With Paclitaxel-Coated Devices (SAFE-PAD) Study—Coverage of SCAI 2022 Scientific Sessions | SCAI

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.  

Other Specialist Resources for Peripheral Vascular Disease

Including recently published studies, coverage of late-breaking science, updates from clinical trials and registries, and complex case presentations.