Boston Scientific’s AGENT IDE Trial Results Presented and Published

March 11, 2024—Boston Scientific Corporation announced the presentation and publication of the primary endpoint data from the total enrollment cohort of all 600 patients in the AGENT investigational device exemption (IDE) trial.

According to the company, the AGENT IDE trial is a randomized controlled trial conducted in the United States examining the efficacy and safety of Boston Scientific’s Agent coronary drug-coated balloon (DCB) in patients with coronary in-stent restenosis (ISR).

On March 1, 2024, Boston Scientific announced FDA approval for the Agent paclitaxel DCB, which is indicated to treat coronary ISR in patients with coronary artery disease. The paclitaxel-coated balloon catheter transfers a consistent, therapeutic dose of the antirestenotic drug to the artery wall via the company’s technology to help prevent ISR reoccurrence, and without leaving behind another layer of metal stenting.

Robert Yeh, MD, who is Principal Investigator of the AGENT IDE trial, delivered the results in a late-breaking presentation at CRT 2024, the Cardiovascular Research Technologies annual meeting held March 9-12 in Washington, DC. The findings were simultaneously published by Dr. Yeh et al online in the Journal of the American Medical Association. Dr. Yeh is Section Chief of interventional cardiology at the Beth Israel Deaconess Medical Center in Boston, Massachusetts.

The company further advised that positive results from the new data set (n = 600) are very similar to those from the prespecified analysis (n = 480) that were presented at TCT 2023, the 35th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 23-26, 2023 in San Francisco, California. The findings were submitted in the FDA application supporting approval of the device.

As summarized in the company’s press release, Agent DCB was statistically superior to conventional, uncoated balloon angioplasty for the primary endpoint of target lesion failure at 12 months (17.9% vs 28.6%; P = .003). This reflected at 41% relative risk reduction with the Agent DCB.

These differences were driven by approximately 50% reductions in the rates of target lesion revascularization (13.0% vs 24.7%; P = .0005) and myocardial infarction related to the target vessel (5.8% vs 11.1%; P = .023) after treatment with the Agent DCB compared to uncoated balloon angioplasty.

At 12 months, the Agent DCB also demonstrated statistically lower adverse event rates. Notably, no cases of definite or probable stent thrombosis occurred in the Agent DCB arm (0.0% vs 3.2%; P = .0004).

The company advised that it plans to launch the Agent DCB in the United States in the coming months. Currently, the Agent device is available in Europe, parts of Asia Pacific, and Latin America to treat patients with ISR and previously untreated small vessel coronary disease.