Sam Brusco, Associate Editor10.26.23
Boston Scientific released 12-month results from its pivotal AGENT IDE clinical trial of the AGENT drug-coated balloon (DCB) at this year’s Transcatheter Cardiovascular Therapeutics (TCT) meeting, the annual scientific symposium of the Cardiovascular Research Foundation.
AGENT DCB is a paclitaxel-coated balloon catheter designed to re-open vessels affected by coronary in-stent restenosis (ISR), then transfer the therapeutic drug to the vessel wall to prevent ISR recurrence.
The balloon catheter demonstrated “statistical superiority” for the primary endpoint of target lesion failure (TLF)—17.9% vs. 28.7%—compared to uncoated balloon angioplasty. Boston Scientific said data showed about 38% relative risk reduction in TLF.
The data also demonstrated 51% risk reduction in target legion vascularization and 49% reduction in myocardial infarction related to the target vessel (TV-MI).
"These encouraging results add to the growing body of clinical evidence supporting the AGENT DCB, spanning nearly 7,400 patients in 14 completed and ongoing studies worldwide," Dr. Janarthanan Sathananthan, MD, chief medical officer, Interventional Cardiology Therapies, Boston Scientific, told the press. "In light of the successful real-world use of the device outside the U.S., we look forward to using these encouraging data to support FDA approval and bringing this important therapy to more physicians and patients in need."
The AGENT DCB was approved in Japan in 2023 and received CE mark in 2014 for treatment of patients with ISR and previously untreated small vessel coronary disease.
AGENT DCB is a paclitaxel-coated balloon catheter designed to re-open vessels affected by coronary in-stent restenosis (ISR), then transfer the therapeutic drug to the vessel wall to prevent ISR recurrence.
The balloon catheter demonstrated “statistical superiority” for the primary endpoint of target lesion failure (TLF)—17.9% vs. 28.7%—compared to uncoated balloon angioplasty. Boston Scientific said data showed about 38% relative risk reduction in TLF.
The data also demonstrated 51% risk reduction in target legion vascularization and 49% reduction in myocardial infarction related to the target vessel (TV-MI).
"These encouraging results add to the growing body of clinical evidence supporting the AGENT DCB, spanning nearly 7,400 patients in 14 completed and ongoing studies worldwide," Dr. Janarthanan Sathananthan, MD, chief medical officer, Interventional Cardiology Therapies, Boston Scientific, told the press. "In light of the successful real-world use of the device outside the U.S., we look forward to using these encouraging data to support FDA approval and bringing this important therapy to more physicians and patients in need."
The AGENT DCB was approved in Japan in 2023 and received CE mark in 2014 for treatment of patients with ISR and previously untreated small vessel coronary disease.