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Study: No major difference in mortality between patients treated with drug-coated and non-drug-coated devices
Peripheral artery disease (PAD), or blockages in the arteries outside of the heart, affects more than 200 million people worldwide and 12.5 million people in the United States. Patients with this circulatory disorder may develop severe leg pain or unhealing wounds that require a minimally invasive revascularization procedure to open the blood vessels to improve blood flow.
For nearly a decade, proceduralists and surgeons have depended on devices coated with a drug called paclitaxel which reduces the need for another procedure by up to 50 percent during procedures to open the arteries of the leg. 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.
Cardiologists at Beth Israel Deaconess Medical Center (BIDMC), designed the Safety Assessment of Femoropopliteal Endovascular Treatment With Paclitaxel-coated Devices (SAFE-PAD) study to provide the information necessary to make scientifically-sound regulatory decisions about the safety of these devices.