Scripps Clinic Cardiologist First in Southern Calif., to Use Newly Approved Drug-Coated Balloon to Clear Clogged Coronary Stent

First-of-its-kind device approved by FDA in March

An image of a new drug-coated stent clearing device, representing how a Scripps cardiologist was first to use it in So Cal.

Image courtesy of Boston Scientific.

First-of-its-kind device approved by FDA in March

Scripps Clinic interventional cardiologist Paul Teirstein, MD, this week became the first in Southern California to use a newly approved drug-coated balloon to clear a clogged stent that previously had been placed in a blocked heart vessel.

The procedure, with the AGENT Drug-Coated Balloon developed by Boston Scientific, was performed in a cardiac catheterization laboratory in the John R. Anderson V Medical Pavilion on the campus of Scripps Memorial Hospital La Jolla shortly after the Food and Drug Administration approved the device for commercial use in the United States.

Every year, more than 2 million stents are placed in the hearts of U.S. patients to open vessels that have become blocked with plaque due to coronary artery disease, which significantly increases the risk of heart attacks, blood clots and heart failure. But over time, 10% of those stented vessels become clogged with new plaque or scar tissue, a condition known as in-stent restenosis, according to research published in 2020. 

“This drug-coated balloon gives us an important new option for treating in-stent restenosis.“

Paul Teirstein, MD

“The procedure this week is just the latest example of Scripps Health bringing innovative medical treatments and technologies to patients in the San Diego region,” Dr. Teirstein said. “This drug-coated balloon gives us an important new option for treating in-stent restenosis, which until now has been limited to therapies that didn’t provide adequate results for some patients.”

Patients with diabetes, small arteries or several layers of stents in vessels are the most prone to the growth of scar tissue, requiring additional procedures months or years following placement of an initial stent, Dr. Teirstein explained.

The new blockage typically has been treated with conventional balloon angioplasty, placement of another stent, cutting away the built-up tissue, or radiation — all approaches that come with their own drawbacks.

In 2021 the FDA granted Breakthrough Device Designation to the AGENT angioplasty system to speed up final testing of the device, which had been approved for use in Europe since 2014.

During the minimally invasive procedure, doctors use a catheter to deliver the balloon through a small incision in the groin into a vein and up to the beating heart. Once scar tissue is removed from inside the blocked stent, the balloon is inflated for one minute to deliver the anti-scar tissue drug paclitaxel, which prevents the blockage from recurring.

Last fall, Boston Scientific reported positive results from its prospective, randomized controlled clinical trial of the device, which involved 480 patients enrolled at 40 U.S. study sites. The data showed that the drug-coated balloon met all targets for safety and effectiveness.

“When used in the appropriate patient, the AGENT balloon decreases the need for repeat coronary procedures and reduces subsequent heart attacks by 50%,” Dr. Teirstein said. “We expect this newly FDA-approved, drug-coated balloon will be a major help to many of our patients who suffer from recurrent coronary artery disease.”

Scripps Health treats more than 212,000 cardiovascular patients every year. Its Prebys Cardiovascular Institute brings together leading researchers, physicians, staff and technologies in one of the most advanced centers dedicated to heart care on the West Coast.

Learn more about Scripps Health, a nonprofit integrated health system in San Diego, Calif.

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Keith Darce

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