FDA Approves AGENT DCB for In-Stent Restenosis

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The approval of the AGENT Drug-Coated Balloon is based on the AGENT IDE trial and was announced by Boston Scientific on March 01, 2024.

The US Food and Drug Administration has approved the AGENT™ Drug-Coated Balloon (DCB) for the treatment of coronary in-stent restenosis in patient with coronary artery disease.

Announced by Boston Scientific on March 1, 2024, the AGENT DCB, which was approved based on a 12-month interim analysis from the AGENT IDE trial, is billed by Boston Scientific as the first coronary drug-coated balloon in the US to provide safe, effective alternative to treat coronary in-stent restenosis and reduce risk of reoccurrence.1

"The AGENT IDE trial demonstrated that the AGENT DCB is an effective and safe treatment option for coronary in-stent restenosis, even in a high-risk population, which included many individuals with multi-layer stents or diabetes," said principal investigator Robert W. Yeh, section chief of interventional cardiology at the Beth Israel Deaconess Medical Center.1 "Treating ISR has been challenging in the U.S. with limited therapies available, and this new technology will help physicians reduce the risk of restenosis without radiation or introducing additional metal layers, which do not provide an adequate result for some patients."

Already available in Europe and parts of Asia Pacific and Latin America for patients with in-stent restenosis and previously untreated small vessel coronary disease, the US FDA approval comes nearly 3 years after the DCB received a Breakthrough Therapy Designation in November 2021.1,2

The AGENT IDE trial was a multicenter, prospective, randomized controlled trial designed to assess whether the AGENT DCB was superior to conventional saloon angioplasty in reducing target lesion failure for treatment of coronary in-stent restenosis. For inclusion in the trial, patients needed to have in-stent restenosis of a lesion previously treated with a bare-metal stent or drug-eluting stent and have a lesion length less than 26 mm.1,2

Patients included in the trial were randomized in a 2:1 ratio to the AGENT DCB or balloon angioplasty. In total, the trial enrolled 600 patients across 40 sites in the US. However, the 12-month prespecified interim analysis used as the basis for approval was based on the first 480 patients enrolled in the trial. Among this group, 321 were randomized to AGENT DCB and 159 were randomized to balloon angioplasty.1

Results of the interim analysis, which were presented at the in a late-breaking clinical trial session at Transcatheter Cardiovascular Therapeutics 2023, suggested use of the AGENT DCB was associated with a statistically significant improvement in rate of target lesion failure (TLF) at 12 months compared to uncoated balloon angioplasty (17.9% vs. 28.7%; P = .006), which investigators noted represents a 38% reduction in relative risk.1,2

Further analysis demonstrated these differences were driven by a significant reception in rates of myocardial infarction related to the target vessel and the need for target lesion revascularization procedure (12.4% vs 24.0%; 51% relative risk reduction; P=.02). Additionally, analysis of secondary endpoints suggested the AGENT DCB was associated with 0 instances of stent thrombosis (0.0% vs 3.9% P =.001).1,2

According to their announcement of FDA approval, Boston Scientific expects the AGENT DCB to be available in the US in the coming months.1

"With more than 100,000 patients treated globally to date in both clinical and commercial settings, we are very pleased to introduce this proven therapy as the first drug-coated coronary balloon in the U.S," said Lance Bates, president of Interventional Cardiology Therapies at Boston Scientific.1 "The AGENT DCB addresses a critical unmet need by providing a dedicated treatment option for the challenging condition of ISR and we look forward to offering US physicians the opportunity to treat their patients with this novel device."


  1. Boston Scientific receives FDA approval for the agentTM drug-coated balloon. Boston Scientific. March 1, 2024. Accessed March 1, 2024.
  2. Boston Scientific Corporation. Boston Scientific AgentTM drug-coated balloon demonstrates superiority to uncoated balloon angioplasty in the agent Ide Trial. PR Newswire: press release distribution, targeting, monitoring and marketing. October 25, 2023. Accessed March 1, 2024.