Boston Scientific Initiates Trial of Agent DCB for Coronary In-Stent Restenosis 

May 11, 2021—Boston Scientific Corporation announced it has initiated the AGENT investigational device exemption (IDE) trial, which will evaluate the safety and effectiveness of the company’s Agent drug-coated balloon (DCB) in patients with coronary in-stent restenosis (ISR).

According to Boston Scientific, the Agent DCB is a percutaneous transluminal coronary angioplasty balloon that is coated with an antirestenotic drug and delivered via the company’s coating technology. This technology was granted Breakthrough Device designation by the FDA earlier this year. The Agent device has been approved in Europe since 2014 for patients with ISR and previously untreated small vessel coronary disease, noted Boston Scientific.

The company stated that the prospective, randomized AGENT trial will compare the Agent DCB to treatment with plain old balloon angioplasty in patients with ISR in lesions up to 26 mm in length in coronary arteries of 2 to 4 mm in diameter. The study will evaluate the 12-month target lesion failure rate, defined as myocardial infarction related to the target vessel, the need for a revascularization procedure, or cardiac mortality. The study plans to enroll a minimum of 480 patients at 40 sites in the United States.

Robert W. Yeh, MD is the principal investigator of the trial.

“While the possibility of ISR remains a challenge for cardiologists, the Agent DCB provides a potential new approach to reopening the vessel and reducing the risk of ISR reoccurrence over time,” commented Dr. Yeh in Boston Scientific’s announcement. “In this new study, we are evaluating a metal-free and radiation-free treatment that could become a safe and more effective long-term alternative for certain patients.” Dr. Yeh is Director of the Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology at the Beth Israel Deaconess Medical Center, and Associate Professor of Medicine at Harvard Medical School in Boston, Massachusetts.