Researchers find no increased risk of death with drug-coated devices used in lower extremity revascularization procedures
This is because peripheral arterial disease (PAD) or blockage of the arteries outside the heart affects many people and minimally invasive revascularization procedures are sometimes employed, but the downside is the potential for severe leg pain and non-healing wounds, so the use of safer devices was studied.
For the past decade, we have relied on devices coated with a drug called paclitaxel during procedures that open up arteries in the legs, and while this procedure has reduced the need for additional procedures, it was discovered that the drug applied has a potential link to mortality two years after the procedure. This was discovered in a 2018 study and it was announced by the FDA to restrict the use of these devices for the treatment of PAD.
The results of the Paclitaxel-Covered Device for Endovascular Treatment of the Femoral Fossa Artery (SAFE-PAD) study provide the information needed to make scientifically appropriate regulatory decisions regarding the safety of these devices, and the Centers for Medicare & Medicaid Services (CMS) Using claims data from the Centers for Medicare & Medicaid Services (CMS), the researchers evaluated survival rates after more than 160,000 leg artery revascularization procedures and drug treatments performed between 2015 and 2018.
The researchers found no statistically significant differences in mortality among patients treated with or without the drugs.
The report was presented as the latest study at a scientific session of the American College of Cardiology on May 16 and simultaneously published in JAMA Internal Medicine.
To ensure the accuracy of these results, several new statistical methods were used and the results were consistent across different patient groups, including patients with lower overall risk, patients with more severe disease, and patients treated in outpatient centers, so the results were provided to the FDA to determine whether to adapt existing or restricted methods of treatment.
