Boston Scientific’s Agent DCB Compared to Uncoated Balloon Angioplasty in the AGENT IDE Trial

October 25, 2023—Boston Scientific Corporation announced 12-month results from the pivotal AGENT investigational device exemption (IDE) clinical trial of the company’s Agent drug-coated balloon (DCB). The United States trial is evaluating the safety and effectiveness of using a DCB to treat coronary in-stent restenosis (ISR).

Boston Scientific’s Agent DCB is a paclitaxel-coated balloon catheter designed to treat in-stent restenonis and prevent its reoccurrence. AGENT IDE is a multicenter, prospective, randomized controlled trial.

The primary endpoint findings were presented in a late-breaking clinical trial session at TCT 2023, the 35th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 23-26 in San Francisco, California.

According to Boston Scientific, the data presented at TCT were from the first 480 of 600 patients enrolled across at 40 sites in the United States. Within the patient population, 44% had multiple stent layers in the target lesion, and 51% were diabetic.

The company reported that the trial met the primary endpoint of target lesion failure (TLF) at 12 months with the Agent DCB demonstrating statistical superiority to uncoated balloon angioplasty (17.9% vs 28.7%; P = .006). The difference was mainly driven by significantly reduced rates of target vessel-related myocardial infarction (TV-MI) and the need for a target lesion revascularization (TLR) procedure.

The data demonstrated an approximately 38% relative risk reduction in TLF. Additional 12-month event rates for the Agent DCB versus uncoated balloon that included:

• Zero definite/probable cases of stent thrombosis (0.0% vs 3.9%; P = .001)
• 51% risk reduction in TLR (12.4% vs 24.0%; P = .002)
• 49% risk reduction in TV-MI (6.4% vs 12.3%; P = .03)

The AGENT IDE trial’s principal investigator is Robert W. Yeh, MD, section chief of interventional cardiology at the Beth Israel Deaconess Medical Center and the Katz-Silver Family Professor of Medicine at Harvard Medical School in Boston, Massachusetts.

“Positive outcomes in this complex trial population—from the markedly lower rate of TLF to the significant reduction in heart attack and no stent thromboses—support the Agent DCB as an alternative treatment option for coronary in-stent restenosis,” commented Dr. Yeh in Boston Scientific’s press release. “Meaningful therapy advancements for this condition are critical, and the ability to reduce the risk of restenosis without using radiation or introducing another layer of metal stenting is a promising step forward.”

In the United States, the Agent DCB is an investigational device restricted by Federal law to investigational use only and is not available for sale. It was granted Breakthrough Device designation by the FDA in 2021. The Agent DCB was approved in Japan in 2023 and received CE Mark approval in Europe in 2014 for the treatment of patients with in-stent restenosis and previously untreated small vessel coronary disease, advised Boston Scientific.