Study Organized by Main Line Health Researchers Reverses FDA Warning on Vital Peripheral Artery Disease Treatment

Four years ago, following a publication based on the limited data available, the U.S. Food and Drug Administration (FDA) warned doctors that stents and balloons coated with a drug designed to improve peripheral artery disease (PAD) treatment outcomes might be linked to increased mortality. Research organized by the Lankenau Institute for Medical Research (LIMR), part of Main Line Health, has led the FDA to remove those warnings and is now being circulated worldwide.

Results of the study on devices coated with paclitaxel were presented today at the TCT 2023 meeting in San Francisco, the world’s largest interventional cardiology meeting. The study shows no increased risk of death from use of paclitaxel-coated devices and has simultaneously been published on a fast-track basis by The Lancet. William A. Gray, MD, system chief of cardiovascular diseases, Main Line Health; co-director of the Lankenau Heart Institute; and LIMR professor, is the study’s senior author. Based on the findings issued prepublication, along with the totality of other supportive data, the FDA issued a letter rescinding its warning in July.

“The study and the FDA’s response restore a critical tool for treating patients with PAD, and we are extremely pleased that LIMR was able to play such a central role,” Dr. Gray said. “Because of the prior FDA warning, far fewer patients had access to a treatment known to be beneficial in preventing arteries from renarrowing due to post-procedural scarring. They were getting inferior procedures or not being treated at all. Now that the regulatory slate has been wiped clean, I hope interventional cardiologists will once again feel comfortable relying on paclitaxel-coated devices again.”

PAD primarily occurs in the legs or lower extremities. It is characterized by the narrowing or blockage of the arteries that carry blood from the heart to the legs and can cause severe pain with physical activity. Approximately 200 million patients worldwide have PAD. The disease is associated with risk factors for atherosclerosis including hypertension, elevated lipid levels, tobacco use and diabetes.

An independent three-physician steering committee comprising Dr. Gray, Dr. Sahil Parikh (Columbia University) and Dr. Peter Schneider (University of California, San Francisco) organized a platform to conduct the analysis. John Wellenbach, clinical business manager for LIMR, obtained contractual agreements from seven manufacturers of paclitaxel-coated devices to provide unrestricted grants to fund a metaanalysis of published studies and to provide their data for analysis, which was conducted with input from the FDA.

“This is a truly consequential achievement for LIMR and demonstrates our leadership in cardiac research,” said George Prendergast, President and CEO. “Thousands of people were negatively affected during the four years the FDA warning was in effect. I’m proud of the efforts of Dr. Gray, John and the rest of the Institute team that aided in this important research.”

The study presented an updated, and likely final, analysis of deaths using the most complete and current data available from pivotal trials of paclitaxel-coated devices vs. devices in the control group. The study pools data from 10 randomized studies.

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