Study: Drug-coated devices show no added risk of death in patients with peripheral artery disease

Illustration of peripheral artery disease showing blocked blood vessel in legs.

Initial results of an observational study demonstrate that drug-coated devices used to treat peripheral artery disease (PAD) provide no added risk of death compared to non-coated devices. The results contradict a previous study that raised a safety concern about coated devices used for this purpose.

PAD, a circulatory disorder that affects more than 8 million people in the United States and millions more worldwide, is characterized by plaque buildup in the legs, which reduces blood flow to the legs and feet. It can cause muscle pain and weakness and may lead to serious complications such as stroke and heart attack. In severe cases, doctors may recommend a surgical procedure to open or bypass blockages in the arteries using a stent or balloon device. 

For nearly a decade, doctors have depended on devices coated with a drug called paclitaxel, which reduces the need for another procedure by up to 50 percent. However, in the wake of a 2018 study that found a potential link between these drug-coated peripheral devices and death after two years post procedure, the FDA restricted the use of these devices for the treatment of PAD out of an abundance of caution.

To further explore the safety of these drug-coated devices, researchers designed the Safety Assessment of Femoropopliteal Endovascular Treatment With Paclitaxel-coated Devices (SAFE-PAD) study. Using data from Medicare patients, the researchers evaluated survival following treatment with either drug-coated or non-drug coated devices in more than 160,000 leg artery revascularization procedures conducted between 2015 and 2018.

The researchers found no statistically significant difference in death rates between patients treated with the drug-coated devices verses non-coated devices through a median follow-up of almost three years (53.8 % with drug-coated devices and 55.1% with non-drug-coated devices).  Additional results at five years of follow-up are anticipated, they said.  The study, partly funded by the NHLBI, was published in JAMA Internal Medicine. The study was accompanied by an editorial written by NIH-supported researchers.